More than a decade ago, when most people were still using not-so-smart mobile phones, the first human genome was sequenced. It cost $3 billion. In the time it took for smartphones to become the essential consumer technology, DNA sequencing rapidly evolved from a costly, uncommonly used process into a quick, reliable, relatively cheap and widely used predictive tool to give insight on disease risk and personalized treatment.

Today, DNA sequencing – largely carried out by San Diego-based Illumina – has since become a critical part of healthcare technology. It is used to develop targeted drugs and therapies, has spawned countless research collaborations and notable investments like President Obama’s Precision Medicine Initiative, and led to the creation of direct to consumer genetic testing kits offering insight on ancestry and snippets of health information. 

But as consumer-focused digital health tools have evolved, those delivering the whole of what genomics have to offer have only recently started to materialize. According to Rock Health, genomics and sequencing shot into the top six categories in digital health funding the first time this year, accounting for $274 million by the third quarter.

Consumer genomics at an turning point

Justin Kao, co-founder and SVP business development and partnership at genetic testing startup Helix, said the industry has reached a time of significant change.

“The consumer genomics industry is reaching an inflection point—sequencing and data storage costs are declining, our understanding of the genome is exponentially growing, and consumer interest continues to increase as well. We believe that these factors will drive enormous growth in the industry,” Kao said in an email to MobiHealthNews.

His company is working on a platform to collaborate with multiple partners, aiming to become a central hub for all things related to DNA sequencing.

“By developing a platform that enables companies of all shapes and sizes to develop novel and innovative applications powered by genomics, we also believe that innovation in genomics will take off. We have seen explosions in innovation on other platforms, such as mobile and cloud, when a hardware problem becomes a software problem,” he wrote. “We’re trying to bring that same disruption to genomics, so that any developer can incorporate personal genomic insights into their product to deliver a richer consumer experience.”

While the FDA still isn’t going easy on direct to consumer testing companies (and has actively called out several who are offering and marketing testing and interpretive analysis without submitting premarket review) that has stopped a new generation of companies from trying.

The buildup to current consumer genomics companies

Recently, we’ve seen a new breed of companies creeping into the consumer genomics space doing one of two things: offering tests that go through third party labs so the company can then offer lifestyle coaching on everything from nutrition to what exercise they can do, or building a new service based on next-generation sequencing. But how ready is it for the consumer market?

Dr. Eric Topol, a geneticist and cardiologist at Scripps Translational Science Institute said the current consumer genomics landscape is a mix of trusted, reliable data and practices as well as prematurely deployed market offerings based on weak science.

“There’s a big, I guess, divergence of companies that are peddling things that have no evidence basis – like nutrigenomics, weight management, sports genomics, all kinds of things, and on the other hand, lots of hard, impressive data for drug DNA interactions and risks of major diseases,” Topol told MobiHealthNews in an interview. “So there is data that is terrific and continues to be evolving, but its not widely commercialized, and then there’s these very questionable entities selling data services that have no basis.”

While companies have definitely come under fire from the FDA, that doesn’t mean the agency can prevent companies that aren’t making any actual health claims from entering the market.

“Just like a lot of things in our world and in America, like supplements, they are not regulated,” Topol said. “As long as they don’t make medical claims, they can sell whatever they want. A lot of people buy this stuff and its really unfortunate. It’s basically taking advantage of people who don’t know better.”
 
Of course, Topol thinks the FDA has a much larger role to play than just saying no.

“There are lot of things that are marketed to the public – tests and supplements and all sorts of devices. I wish this stuff could get fixed,” he said. “I wish the FDA and Consumer Reports and other public citizen watchdog agencies could provide this honest, objective recording and advise the public, but unfortunately, it isn’t being done.”

He also thinks the FDA should work with reputable consumer genomics companies to allow them to deliver more health information.

While products like 23andMe’s saliva-testing kit paved the way for consumer genomics by getting people curious about their ancestry and their health, the FDA decreed such companies could only give limited health information without going through a clinician. In 2013, the company was ordered to immediately stop selling its testing service. In a public letter, the FDA made it clear that they would require clearance for each of the myriad genetic tests 23andMe performed on each partially sequenced genome, which created a serious impediment to 23andMe’s approach. 

The company stopped selling the home testing kits, save a version that would return ancestry information only. After that, 23andMe began selling the service in the UK, while declaring its intention to comply with FDA regulations stateside. They submitted a clearance request for their DNA test for Bloom Syndrome. That test was finally approved in February 2015 as a de novo clearance, meaning the FDA didn’t consider any predicate device to exist. As the company awaited clearance, they raised $79 million to shift focus on research and drug development, and began selling a new test in the US again in October 2015. At the time of the relaunch, 23andMe branded the new offering as better than before, but it doesn’t offer all the same level of disease risk analysis as the first.

“I think they were actually making a nice contribution: giving people not only drug-DNA interactions, and recessive allele but many disease risks,” Topol said. “I think it’s unfortunate that that was taken down by the FDA and they have not brought all of it back.”

23andMe currently offers genotyping, which examines a set of points on the genome to learn ancestry, relationships and some health risks. Though the company began working on efforts to develop exome, or next-generation sequencing, which offers a much larger information to the consumer, it abandoned that plan in October and said it will instead focus on its current offerings.

“Everything we do at 23andMe is in hopes of supporting our customers today and tomorrow, by driving scientific research and furthering the study of genomics in a variety of ways. In addition to our consumer product, we also have our therapeutics team, which is working to help transform the way we discover and develop novel therapies,” a 23andMe spokesperson told MobiHealthNews in an email.

The company wouldn’t comment specifically on what they have planned for the next few months or year, but emphasized the still-nascent factor of consumer genomics.

“By starting with genetic information and understanding the basics of disease, we hope we can make discoveries that will have a meaningful impact on society at large, much beyond our customer-base,” the spokesperson said. “We aim to be a trusted source as understanding of human genetics evolves—we will definitely know more about genetics tomorrow than we do today.”

Another leader in the “omics” space is San Francisco-based uBiome, which makes a direct-to-consumer microbial genomic testing kit. The company recently beefed up their repertoire by adding a new DNA- sequencing-based screening test called SmartGut to their offering.

With an at-home collection kit, SmartGut aims to give individuals and their doctors access to a comprehensive screening test to weed out important microorganisms (which can only be detected through DNA sequencing) that could be causing health distress. The test, which is not yet available, requires users to swab a tiny amount of fecal matter with a cotton swab, and the material is sent directly to the UBiome laboratory for sequencing. Once the results are back, SmartGut will give users actionable information about their gut microbiome to share with their doctors.

Topol pointed to companies like uBiome and 23andMe as standouts for their clinical validation and peer-reviewed work, and said all companies getting into the space should put out evidence-based data supporting their work.

“We don’t see that when you are peddling things like what food you should eat and what sports you should be doing. There’s a whole spectrum, and you like to educate the public while giving them information that’s at least worthy,” he said. “I’m aware of companies that have done very good work, but as far as the ones that are food and athletics, and one that just came out about what wine you should drink? I mean it’s just absurd.”

Topol didn’t name names, but one such company has been on our radar. Vinome, a Northern California-based wine delivery service that will be teaming up with Helix, is packaging a service that offers people wine personalized to their DNA. While there is a dearth of science to back up whether such a specific pairing could be made, the company is more focused on giving consumers a fun experience. Vinome soft-launched earlier this year and has already shipped some 300 bottles of wine to customers, according to Stat News. 

Vinome starts by asking customers their taste preferences, and then looks at variants in their genes on taste receptors  (gleaned from the results of a saliva DNA testing kit). Given that there is only a small amount of research suggesting that certain genes are equated with certain tastes, Vinome set out to do their own research by analyzing genetic variants in 500 people, who then did taste tests. It was then that Helix got interested.

“Helix understands that there are no genetic studies that show genetic polymorphisms related to individual wines,” Dr. James Lu, Helix’s senior vice president of applied genomics said in a statement to Stat News, saying Helix is, “excited to partner with Vinome because of their novel, fun and modern approach to building a wine recommendation algorithm.”

The important thing with offerings like these is for consumers to understand the state of genomics understanding. Another recent report by Rock Health exploring the implications for healthcare said the more consumers are brought into genomics research, the better, because the field needs all the data it can get.

“One of the primary aims of genomics is to generate personalized and actionable insights that lead to better health,” the report stated. “Because much work is still needed to understand how genes influence and interact with a person’s health, scientists need greater amounts of diverse genetic and phenotypic data (e.g. personal health information) and unfettered access to those linked data sources.”

This can be achieved by building awareness around the field of genomics, creating better consumer products and devising more relevant consumer use cases, the report said.

“Genetic data in the ecosystem increases when consumers buy direct-to-consumer genomics products, opt in at the physician’s office to get a genetic test, or participate in clinical research trials. The genomics industry can and should encourage participation at these touch points.”

Expanding the range of consumer genetic tests

While 23andMe is still the leader in consumer genomics, that doesn’t mean other digital health companies are too intimidated to miss out on the estimated $2 to $7 billion market, and others are now stepping in to deliver that next-generation sequencing.

Personal genomics startup Helix, which we mentioned is developing a digital hub for all things related to DNA testing ranging from direct-to-consumer to doctor-ordered, announced a slew of notable partnerships: the Icahn School of Medicine at Mount Sinai, National Geographic and a startup called ExploraGen. All will collaborate to deploy Helix’s Illuminia-powered genetic testing-service. The company also partnered with genetic information company Invitae.

Helix aims to offer an approachable platform for people who order DNA tests from multiple organizations – National Geographic’s popular ancestry product, Gene 2.0 Next Generation will launch on the Helix platform in November. Helix will send the saliva swab kits, sequence their DNA and store data in the cloud, and National Geographic will look for the ancestry markers in the DNA. Additonally, innovation company Exploragen is working on a number of applications that match DNA and the science of taste to create personalized “epicurean experiences,” according to the company. (The first offering will be Vinome).

Helix’s test will offer advanced exome sequencing, which looks at the part of the genome that encodes genes, which other direct-to-consumer tests have not offered. With all the partnerships, however, it hasn’t been decided how exactly consumers will pay for the centralized digital platform to access their genetic interpretations (aside from the National Geographic test, which runs $149).
Rather than focus on building one singular app at this time, Helix aims to be the facilitator for others to create new consumer genomics products.

“By handling the lab processes, ecommerce, sample collection, data storage, and associated logistics and operations, we’re enabling our partners to focus on what they’re best at—developing innovative software and applications for consumers,” wrote Helix co-founder Kao in his email to MobiHealthNews. “With this model, partners (large, trusted companies or lesser-known indie developers) will be able to develop DNA-powered applications that previously would have been impractical due to the associated fixed costs.”

Kao envisions the future of genomics will become as “a software problem, not a hardware or chemistry problem,” that will also be increasingly more affordable to consumers.

“In fact, developers don’t need to ever understand the complexity of sequencing itself because that’s what Helix spends all of its time on,” he wrote. “On the Helix platform, we anticipate that there will be DNA-powered applications available for less than $20.”

The partnership with the Icahn School of Medicine at Mount Sinai marks the company’s entrée into healthcare in ways that put it on a new level unlike competitors like 23andMe. The first Mount Sinai application on the Helix platform will be only be available with a clinician’s approval, and will allow prospective parents to learn about their risks of potentially passing on certain inheritable genetic disorders to their children. Additionally, genetic counseling will be offered.

“There is definitely an awareness of where all of this is going – consumer genomics is one of the next frontiers,” Dr. Yvonne Chan, director of digital health and personalized medicine at Icahn told MobiHealthNews in an interview. “There’s one thing about practicing clinical care, but really using digital technology to reach the masses is something that is really awesome.”

 Chan explained how the partnership with Helix will enable Mount Sinai to offer a whole genetic sequencing and counseling experience to a much wider range of people.

“We recognize there is a subset of the population that is not being served,” Chan said. “They might be interested in learning about genomics, divining some insights with the absolute medical need or urgent applications. With the Helix partnership, we can launch, on their main platform, a product that will be all-inclusive and offer everything genetic counseling has to offer, and by expanding this to more people, we will learn more about what patients want to hear, how they need to hear it."

While the Icahn-Helix partnership will have the benefit of genetic counseling, one of the hitches in expanding consumer genomics is the relative dearth of qualified experts to talk with patients.

“There is a relative lack of genetic counselors for this essentially booming new area,” Chan said. “This is where I really embrace digital health and advocate where it could really help fill that void. Any time there is a real supply and demand for a resource like genetic counselors, we could start looking at things like telemedicine and unlocking workforces that would not be available and also automating more mundane processes so we can leave the human touch in place.”

Chan embraces the enthusiasm over consumer genomics, but tempered that by acknowledging the field is ripe for misuse or misinformation.

“Think of it this way. I recently became addicted to Twitter. You are just bombarded with a whole spectrum from truly reliable information to garbage,” she said. “And there’s that same spectrum on what we call the strength of scientific evidence. There are some that have been truly studied, replicated and trusted, and those that are just hearsay.”

Another issue with all that genetic information is what to do with it, Topol said. As consumer genomics matures, it will be critical to develop the right tools and programs to make all that data actually usable on a daily basis.

“No human being, no doctor could ever process all that data. It’s speeding continuously, and it’s perfect for machines to do, and I think that is where you’ll see this thing take off in a really big way,” he said. “If you’ve ever used a virtual assistant, it takes getting used to, but then you realize, oh my gosh, this is actually pretty remarkable and its just scratching the surface of where it’s going to go, especially when you talk about each person’s health and medical side of life. That’s why you have computing. Good algorithmic software processing preempts TMI.”

Speaking of knowing more: another company looking to give consumers even more information about their DNA is Boston-based Veritas. While entire gene sequencing is normally only done in clinical setting for specific conditions, Veritas wants to democratize the entire gene sequencing experience to anyone and everyone. The company recently announced the availability of myGenome:  a $999 service that includes whole genome sequencing, interpretation and pre- and post-test genetic counseling. Consumers can use an app to explore their results. 

The company initially launched last year with a $199 test to identify specific gene mutations, then expanded to a $299, 26-gene test in January that could assess certain genes associated with a heightened predisposition to certain cancers. But myGenome tops all of that by offering the whole sequencing, plus on-demand video counseling, and the company believes the $999 tag is the price point that will drive mainstream adoption of the technology. 

Consumer genomics tackles wellness

Using a genetic sequencing test as a jumping-off point, several so-called wellness companies have risen up to offer what others aren’t quite yet: actionable insight, albeit based on some very basic genetic data and offering no medical claims.

In September, Seattle-based Arivale began selling a saliva kit and companion app to create tailored plans they bill as the “scientific path to wellness.” Arivale offers people a package that includes a Fitbit, collection containers for saliva, urine, cheek swabs, and a prescribed order of blood tests to do on their own time, plus a companion app. Users download the app and complete an online assessment to share goals, health history and lifestyle, stress levels, personality and happiness. Once the data results are in (analyzed by independent, external clinical partner, LabCorp) users are paired with an Arivale coach. The goal is to create a personalized data cloud for each user based on their genetics, clinical lab results, gut microbiome, sleep and activity level.

While individuals are forking over quite a bit of themselves, Arivale isn’t looking for information on any sort of diseases or disorders, and they aren’t offering up anything as involved as genetic counseling, although that is a long-term goal.
Toronto-based Newtopia offers a health management and coaching plan based on genetic testing and behavioral science.
Through testing, personalized coaching, and a connected scale and activity tracker with a companion app, Newtopia’s goal is to reduce preventable, chronic diseases like obesity, type 2 diabetes, heart disease and stroke. The platform works in four steps: Employees complete an online profile to assess their current health and lifestyle choices, then mail in a saliva sample, and, once the genetic test results are in, they are matched with a personal coach. Together, they then work to take actionable steps towards better health.

Habit, a personalized nutrition startup backed by $32 million from Campbell’s Soup, announced plans in October to launch in 2017. Consumers will form a new Habit when they purchase a test kit and collect data about their genetics, their vitals, and their metabolism, which is sent to a lab. They also input data about their health goals. Then the company uses that data and machine learning algorithms to determine the user’s ideal diet. The user receives online guidance from a diet coach and specially-prepared meals delivered to their door. The company will also have an app that allows users to track progress and connect with one another socially.

”Look around you. We are all different shapes, sizes, ages, genders and we all have different lifestyles. It’s just common sense to reject the idea that we all need the same food, in the same amounts, at the same time,” Habit CEO Neil Grimmer wrote in a blog post. “Science now backs up this common sense. Our bodies need different things. Our biology, our DNA, the blood running through our veins tells us that. We just need the tools to tune into our bodies and listen to what foods it’s asking for.”

So, even though consumer genomics is still in its infancy, we’ve seen a number of companies coming into the space and leveraging the innate curiosity people have about themselves and working to transform that information into a guide for living based on their genes. But the science lighting those paths is still fuzzy.

“Genomics is really mind-boggling,” said Chan. “We’ve come so far, but at the same time, we need to remain really humble. It’s a process and evolution, and some stages are still really early. We have not solved all of the problems. It’s going to be tricky if people are not careful, responsible and critical.”
 

A tiny new wearable designed to be worn on a baby or toddler’s wrist will soon be an option for families in the United States and European Union. Neebo, a baby monitoring device from Czech Republic-based Daatrics, has opened up pre-orders and will begin shipping by spring 2017.

The small, egg-shaped wearable aims to give parents and guardians peace of mind by tracking vital signs and any sound the baby makes, flagging any abnormalities and notifiying parents via a companion app. Neebo monitors heart rate, oxygen intake, body temperature and sends information via Bluetooth to a smartphone companion app as well as central device that can be placed in the baby or child’s room. The device, which runs on a battery that lasts a week, also picks up sounds from the baby – not surrounding sounds in the room, which can make for too much noise on traditional monitors – alerting parents of signs of distress or simply the baby being awake. 

“When I became a parent for the first time, I was really crazy,” Daatrics CEO Andrey Kharullaev told MobiHealthNews in an interview. “Me and my wife were worried all the time about the baby, and we really wanted something that would give us peace of mind, especially when they were quiet.”

Kharullaev assembled a team to work building a prototype of Neebo, which is in its iteration and will get smaller and more sensitive by the time it is ready for shipping. Since it is worn on the wrist, it had to be safe for the baby to chew on, and also had to have a childproof clasp.  On top of that, it had to be smart enough to tune out false alarms.

“It’s built around the idea that parents don’t need a lot of extra alerts,” said Kharullaev. “These are smart alerts. If it cannot deliver to mobile, it goes to the charging station and it produces a smart an audible alert, but only in case of emergency, such as abnormal heart rate or a high or low temperature.”

Similar to other baby monitoring wearables like Owlet or Sproutling, Neebo measures heart rate and oxygen intake. But Neebo is worn on the wrist, and plans to add more biometrics. Kharullaev said they definitely want to pursue FDA clearance.  The company, which has thus far only done internal, unofficial testing with children in the Czech Republic, is currently in talks with a hospital in Portugal to begin studies for clinical validation, and is eager to begin more studies across the EU and US.

“We are also giving away the API to certain parenting apps, and are looking to connected health platform integration as we move towards FDA submission,” said Kharullaev.

While the wearable is just monitoring the basics for now, the Neebo team eventually wants to apply AI and more sophisticated sensors to form an “eavesdrop feature,” notifying parents or guardians if another caretaker or person is harming or yelling at the baby.

“With the final iteration, it will start to educate the AI and detect baby abuse – slapping, yelling, pushing – and will start to analyze the audio environment to detect patterns,” said Kharullaev. “We want it to be able to detect the event and confirm with other sensors to work with higher accuracy.”

The company is limiting pre-orders to 2,000, and it will sell for $199 during the initial phase before it goes up to $295. As the Neebo team is working on making the device smarter and more sensitive, they are looking towards the future applications for their device. Kharullaev said the company has received a lot of attention from parents of children with health issues like respiratory illness, or those with special needs.

“You may be in a situation where you just need to be away from your baby and want to know what is going on around them,” said Kharullaev. “Particularly when you are in places where you don’t have maternity leave, you have to work, you don’t necessarily have a medical need to know, but you want to trust you can leave your baby alone. You just want to know.”

Fertility apps aren’t just for women. A new male fertility kit and companion app from Medical Electronic Systems, which makes commercial-grade automated semen analyzers, allows men to test their semen at home using their smartphone.

The test is called YO, and features a clip-on mini microscope that users attach to their smartphone, plus a sample collection cup, a testing slide, a plastic pipette and a special liquefying powder. Users start by opening the app and assembling the supplies, then get to work producing a sample. That’s the easy part, as the next few steps require some serious attention to detail.

Once the user has a sample, they then mix the powder into the collection cup and swirl it around for 10 to 15 seconds before letting it rest for 10 minutes. As the sperm is resting (which is timed on the app), users can play a sperm trivia game on the app. Then, they pipette a bit of the sample onto the slide, insert the slide into the clip, and tap “start testing.” The app takes 30 seconds to take a video of the same, then spends a couple minutes analyzing before the video appears on the screen along with a sperm count and motility.

The idea is to give men an idea of their fertility status without having to walk into a doctor’s office and do the highly personal and oftentimes embarrassing process there. With the YO test, a man can just do it at home and show it to a doctor later.

“The explosion of apps and wearables dedicated to optimizing the chance of pregnancy is evidence that people crave more awareness of their fertility status. However, the bulk of these new technology tools cater to women. No other company is tackling male reproductive health in this manner,” Marcia Deutsch, CEO of Medical Electronic Systems said in a statement.

While there have been other home test kits available, Deutsch said YO is different in that it also offers a motility assessment in addition to a sperm count.

“If a man is producing 100 million sperm and they are all dead or not swimming, it’s useless to know your sperm concentration is 'normal'. The key is to assess sperm that are moving, as these are the sperm that will fertilize an egg during normal conception,” Deutsch said. “YO is trailblazing a new approach offering consumers valuable and reliable information and bringing clarity to one of life’s biggest moments, that of starting a family.”

The test is geared towards men who may be concerned about fertility status, whose spouses or partners are having a problem conceiving and want to know if it is due to the man’s fertility (which is the case in approximately 40 to 50 percent of infertility cases), men who want to know more about their reproductive health, or those who are simply curious and want to see their live sperm up close and personal.

The test, which is now in preorder on the company’s website, sells direct to consumers at $49.95 for two tests and will begin shipping in January 2017.  

Angel, a company that has been working since 2013 on an open source wearable tracker that could be programmed for different use cases, has shut down the project and, likely, the company. 

The company announced the news via a large banner on its website reading "This project is no longer active". Angel executives did not respond to MobiHealthNews's request for an interview. Bob Troia, known as "Quantified Bob" in quantified self circles, spotted the announcement and posted about it on Twitter and on the Quantified Self forum.

"Well, looks like the Angel Sensor folks have (finally) officially thrown in the towel,"he wrote. "Not really a surprise, as they had gone silent for nearly a year after delivering their crowdfunded product over two years late. They did release code for their open-source SDK, and there is a community of developers who have forked it on GitHub3 to continue development. Too bad they gave up, as the promise of a truly open source wearable with an array of useful sensors is lacking in the QS space."

Angel completed a well-funded Indiegogo campaign in late 2013, raising $334,000 out of an original goal of $100,000. The wristband could measure pulse, temperature, activity and blood oxygen level and was aimed at researchers, hackers, and quantified selfers.

"Angel is the first device designed with developers in mind," the company wrote on its Indiegogo page. "Currently most trackers for fitness and health are built for use by a single proprietary app. We want to change that. We are opening up communication protocols, API/SDK and sensor data streams. Ultimately, this will mean more apps to choose from."

But, as is often the case, the company ran into a number of manufacturing problems. The company's last blog post, from April 2015, lays out some of these struggles. 

"We’ve been through a really rough patch over these past months," the company wrote. "We’ve experienced engineering and financing difficulties, downsized our R&D and fought many battles to keep the project alive."

It's unclear whether all of the backers even received their devices. In addition, prior to shutting down, the company was taking pre-orders for both the original wearable and a second-generation device.

The open source nature of the product means that some of the researchers that had already begun to use the device should be able to continue, though they may run into trouble if they want to scale the project or replace a defective unit. For instance, a Spanish university launched a project using the Angel Sensor to detect epileptic seizures just last month.

London-based genomics company DNAFit has launched Elevate, an online training platform that incorporates users’ genetic information to create personalized workout plans.

Elevate, which DNAFit developed with the input of Olympic track and field athlete Greg Rutherford, is based on the company’s saliva-based genetic test kit. It screens for 45 specific gene variants, which may be linked to each individual body’s ability to respond to training and nutrition, such as those identified as being linked to obesity.

The $126 (99 British pounds) test then algorithmically calculates a score for each user to determine their endurance response, and this figure is then plugged into the Elevate online platform people can access on their smartphone, tablet or laptop. Users add their weight and other vital statistics and the days they are able to train, and the app guides them through the workout with a training schedule and videos of how to perform exercises.

“The ‘best way to train’ has long been a topic of hot debate, but it is now clear that the answer to this is an individual journey that requires the consideration of a person’s lifestyle demands and biological profile,” DNAFit founder Avi Lasarow said in a statement. “Whether you’re looking to shape up, build muscle or just want to eat a little healthier, your genetics hold valuable information about the best way to do this.”

While there still isn’t a lot of firm data to support claims that specific dietary and workout plans can be optimized for each individual based on their genetics, (geneticist Dr. Eric Topol recently told MobiHealthNews that the consumer genomics landscape is still in its early days) researchers are working to figure that out.

A recent study at the University of Central Lancashire, published in the journal Biology of Sport, suggest that those who train to their possible genetic “strengths” improved their athletic performance up to three times more than those who were using a regular training program.

Geneticist Dr Keith Grimaldi, one of the authors of the study and an advisor to DNAFit, said Elevate could be a valuable tool that takes the guesswork out of trying out different training and nutritional plans.

“We know quite a lot about some genes that do affect your biochemistry and physiology. So, we add this factor into the picture,” Grimaldi said in a statement. “If you don’t know your genes, you’ll just have to guess the right training and diet regimes by trial and error, and we want to reduce this with an extra layer of personal information from the genetic point of view.”

It's been a rough couple of weeks for wearables. Yesterday, Lenovo announced it was abandoning its Moto Androidwear line indefinitely, with head of global product development Shakil Barkat saying "wearables do not have broad enough appeal for us to continue to build on it year after year,” according to The Verge. Last week it came out that Pebble, which arguably invented the smartwatch space, is being bought by Fitbit for a price that reportedly won't cover its debts. And Angel, which was to be the open source wearable that allowed anyone to adapt the technology to their needs, also shut down recently (MobiHealthNews broke the news last week).

If that's not enough for you, go back a little further and you'll see Intel laying off its wearables group and killing the Basis line and Microsoft essentially killing the Microsoft Band back in October. And that's without even mentioning Jawbone, which has been in a sort of slow motion decline for months if not years without a new product in sight. This is surely not a complete list.

With all that, it's enough for some to start making some rather grim predictions for the industry. Earlier today, Variety magazine pronounced the smartwatch dead, pointing out that even Apple is seeing big declines in shipments for the Apple Watch. And if the smartwatch is dead, the fitness tracker doesn't seem all that much healthier, judging by most of this recent news.

It could just be denial, but voices in digital health are painting all this news with a slightly more hopeful brush. Dr. Dave Albert, inventor of the AliveCor smartphone ECG, said on his Twitter that he thinks wearables have entered 'the trough of disillusionment'. That's a reference to the Gartner hype cycle, a theory about how technology adaptation happens. In the hype cycle, the trough of disillusionment follows the "peak of inflated expectations" and is the lowest point in the cycle: it's followed by the slope of enlightenment and the plateau of productivity.

All of which is to say that maybe the shutdowns and consolidations are a prelude to the beginning of a healthy market. Rachel Kalmar, a fellow at the Berkman Klein Center for Internet & Society at Harvard University who has previously worked for Misfit Wearables, gets at the same idea in a blog post she published today. Kalmar posits that the thing that will bring wider, mainstream adoption to wearables is bridging the gap between collecting data and using it productively -- whatever that means for each individual device and consumer.

"I often compare wearables to mills for grinding wheat into flour,"Kalmar writes. "Though some consumers have ideas of things they’d like to bake, most don’t want flour, they want cookies. The same is true for data: most people don’t want the data itself, they want cookies: the useful products and services that are built with this data. The problem is that for wearables data, we still don’t know what a cookie looks like. This is not the fault of wearables companies, but rather a reflection of where we are as a field."

Kalmar thinks that as we as a society and an industry solve this problem of a lack of meaning for the data, wearables will have a corresponding comeback.

It's also worth noting that "dead" in the consumer realm doesn't always mean dead in the enterprise. We saw that with Google Glass last year, which, even after its consumer program shut down, continued to have uses in enterprise, especially healthcare. And if Kalmar's reasoning is correct, this makes sense for wearables too: While consumers might still be looking for the reason to wear a smartwatch, a person with epilepsy knows exactly why they're wearing the Embrace watch from Empatica, for instance.

We noted earlier this year that consumer wearable companies seem to be moving more and more into enterprise healthcare. That move could turn out to give those companies an important edge.

Fitbit confirmed the rumored acquisition of Pebble today, but clarified that it is not acquiring the business in its entirety -- only the software IP and some personnel. Notably, Fitbit won't take on Pebble's debts or it's hardware assets, which the company could still sell in a separate deal, and Pebble CEO Eric Migicovsky will not start a job at Fitbit. Instead, according to a report in Bloomberg, he'll be moving to a position at Y Combinator. 

“With basic wearables getting smarter and smartwatches adding health and fitness capabilities, we see an opportunity to build on our strengths and extend our leadership position in the wearables category,” James Park, CEO and cofounder of Fitbit, said in a statement. “With this acquisition, we’re well positioned to accelerate the expansion of our platform and ecosystem to make Fitbit a vital part of daily life for a wider set of consumers, as well as build the tools healthcare providers, insurers and employers need to more meaningfully integrate wearable technology into preventative and chronic care.”

Pebble also posted a farewell message as an update to its latest Kickstarter campaign, in which it confirms that the Pebble Core and Time 2 devices will not be shipped and anyone who pre-ordered those devices will be refunded. As for the fate of existing Pebble devices, the company hopes to allow users to keep them running for a while at least.

"Active Pebble watches will work normally for now," the company wrote. "Functionality or service quality may be reduced down the road. We don’t expect to release regular software updates or new Pebble features. Our new mission will focus on bringing Pebble’s unique wearables expertise to future Fitbit products. We’re also working to reduce Pebble's reliance on cloud services, letting all Pebble models stay active long into the future."

For many, losing functionality of a Pebble device will be an annoyance or an inconvenience, but for a few it might be much more than that. Pebble was one of the preferred wearables for the Nightscout project, a crowdsourced DIY project in which people with diabetes network their own insuling pumps, CMGs, smartphones, and wearables together to regulate their glucose levels. Nightscout posted an update on its Facebook page saying that Fitbit is committed to supporting the project.

"(1) The infrastructure will remain in place, the lights are going to be on for quite a while. Short- and mid-term, don't expect any changes to existing devices in the wild," James Wedding wrote on the group's Facebook page. "(2) For now, they plan to keep the Pebble app in the app stores to support existing devices. This could change, but they wouldn't take something away without a plan to keep functionality going. 
(3) Many of the folks going over to Fitbit know about Nightscout and are well aware of this project. They're going to get through this change, and then we'll start looking at how we can continue to develop together."

Bloomberg reports, citing anonymous sources, that about 40 percent of Pebble employees, mostly software engineers, got job offers. It remains to be seen what that means for Pebble's impact on Fitbit culture and offerings. In Pebble's farewell letter, they encourage their fans to reach out to Fitbit and encourage the company to adapt Pebble features.

"Pebble’s expertise, philosophy, and culture will live on at Fitbit," the company wrote. "Much of our team and resources will join Fitbit to deliver new 'moments of awesome' in future Fitbit products, developer tools, and experiences. As our transition progresses, we’ll have exciting new stories to tell and milestones to celebrate. It’s a bittersweet time, no doubt. We’ll miss what we’re leaving behind, but are excited for what the future holds. It will be important for Pebblers to extend a warm welcome to Fitbit—as fans and customers—sharing what they love about Pebble and what they’d like to see next."

Orbita announced its Voice Experience Designer at the Connected Health Conference on Monday. The company described the software as a graphical tool healthcare organizations can use to build voice assistants that aid patients in their homes.

“We provide the connectivity services, the orchestration logic for data that comes in and collaboration app for caregivers to communication with patients,” Orbita Co-Founder and President Nathan Treloar said. “We want to be able to work within care plans.”

Likely applications include medication adherence, pain management, patient monitoring and coordination among various caregivers, the company said.

Treloar also said that it will begin collaborating with the Boston-based Commonwealth Care Alliance next year to put the Voice Experience Designer to work in patients’ homes.

“Alexa is a way for people to report objective data, such as blood pressure readings, as well as subjective data, like ‘I don’t feel that great today,” Treloar added.

That said, while the version Orbita is showing at the Connected Health Conference works with Alexa, Treloar said the company is not prescriptive about which voice assistants its software will run on and, in fact, it's already working on Google Home, Apple Siri and Microsoft Cortana iterations to follow sometime next year -  just not before HIMSS17.

“Right now we’re completely focused on getting shored up for HIMSS,” Treloar said.

In Orlando Orbita will be showing the Voice Experience Designer, as well as tools for patient journey management, the care coordination experiences and the entirely new Care Pathways Manager.

“We’re planning to have those ready and demonstrable at HIMSS,” he said.

Globally and in the US, use of connected health devices is still low and hasn’t changed since last year, according to extensive survey data from Ipsos, shared today at the Connected Health Conference in National Harbor, Maryland.

“What we lack is objective data,” Reena Sangar, head of digital and connected health at Ipsos, told conference attendees. “The data [that’s out there now] is very US-centric, lots of different stats that are difficult to decipher. So we felt there was a real gap here. One of the really important things to really increase adoption is to understand the profiles of individuals using connected health.”

Ipsos interviewed a total of 18,180 individuals representing a total of 23 countries. They found that, worldwide 12 percent of people said they currently used a connected health device (including fitness trackers) and another 12 percent said they had formerly used one. But this wasn’t at all the same across all countries. 

People in China were the most likely to use a connected health device, with 28 percent responding that they did, followed by India with 26 percent and the United States with 21 percent. Turkey and Indonesia rounded out the top five. The US had a comparatively low dropout rate, with only 10 percent saying they formerly used a device.

On the other hand, Polish respondents were the least likely to use a connected health device, at just 3 percent, followed by Peru at 4 percent, Russia and Brazil at 6 percent, and Japan and France at 7 percent.

Ipsos conducted a similar survey last year in just a few countries, and saw adoption staying steady in most, with only Japan showing a slight increase.

Not all countries’ residents used devices for the same reasons. China, India, and the US all said they were mostly interested in monitoring and improving exercise, whereas Turkish responders said they were interested in their own health data and Indonesians wanted a device to store health data.

In the countries with low adoption, however, the top two barriers were all the same: cost and lack of knowledge about what wearables can do.

“Cost is there as a barrier, often is, but I think the most important thing in this slide is ‘I don’t know enough about them’,” Sangar said. “I wouldn’t take that as awareness. What it means is ‘I don’t know enough about what it would do for me’. And that’s the piece that’s missing.”

Outside of the country breakdown, Ipsos found somewhat predictable results about who uses wearables: 25 to 34 year-olds are most likely and groups get less likely as they older. Educated and working class people are more likely than uneducated and low income folks.

Most interestingly, they asked respondents whether certain stakeholders, namely their doctors and insurance companies, could persuade them to start using a tracking device. Globally, 85 percent said they would use a device if their doctor recommended it and 68 percent would use a device if their insurance company recommended it. Here in the US those numbers were quite a bit lower, at 68 and 49 percent, respectively.

“The role of the health care professional and health insurers will need to be better defined as we plan the new human-centered design of healthcare,” Sangar said. “Because without them it’s not going to happen. We have to empower the healthcare professional because they are the heart of the health service.”

Consumer adoption of digital health has reached its tipping point. More people than ever are using wearable devices, accessing telemedicine, and going online to search health information. They are also more willing to pay for digital health tools, more willing to share their data, and want to take more ownership of their health, according to a new report from San Francisco-based venture fund Rock Health.

In a survey of over 4,000 consumers, Rock Health found 46 percent are considered active digital health adopters, meaning they have used three or more categories of digital health – which includes telemedicine, wearables, apps or mobile health coaching. That’s up from 19 percent just a year ago.

Consumers and are also using digital health tools at the behest of their physicians –nearly a third downloaded a health app because their doctor recommended it. The most popular metrics they record are activity, at 44 percent, and heart rate, at 31 percent. Blood pressure and medication adherence are the least-recorded metrics, at 14 and 10 percent, respectively.

Nearly a quarter of Americans own a wearable, up from 12 percent last year. With the top most popular being Samsung, Fitbit and Apple. And experts surveyed for the report said these devices could see even more adoption if they are integrated with user’s personal healthcare.

“People would be more inclined to use wearables and track their health if they knew their physician was using that information and it directly impacted their clinical care,” Boston Children’s Hospital Chief Innovation Officer John Brownstein was quoted as saying.

A big draw to adopting digital health tools could be the desire for health data ownership and control, the report found. Nearly 87 percent of survey respondents said they want to be in control of who has access to their data, and 86 percent want to know what data is collected about them.In 2016, 20 percent of consumers asked for or downloaded a copy of their electronic health record. Even with privacy and security concerns, 77 percent want to share their health information, especially with their physicians and family members. While these two groups are the most trusted by individuals, government and tech companies are the least, demonstrating that consumers feel these entities’ interests are less aligned with theirs.

“Americans are more altruistic than they are greedy,” the report authors wrote. “More people would freely share their health data to contribute to research (62 percent) than would share their data in exchange for money (42 percent).”

All tech companies aren’t viewed equally, of course, and Google was ranked the most trusted tech company in digital health. While we continuously see IBM Watson in the space, they ranked last.

The report also found 2016 was an “impressive growth year for telemedicine,” with video-based telemedicine adoption more than tripling to 22 percent usage in the last year. In 2015, only 7 percent of consumers had used it. Telephone is the most popular medium for telemedicine, followed by email and text, but the highest satisfaction is from live video. Across all platforms, though, satisfaction rates are high – 75 percent. When it comes to paying for telemedicine, consumers are still primarily responsible for the cost of telemedicine themselves, with 30 percent of visits self-paid versus 11 percent by insurers and 10 percent by employers.

Even novel consumer technologies, like virtual and augmented reality, are being used at home for things like mental health, pain management and rehabilitation. While it’s not just for younger folks, millenials are still the driving force in digital health adoption, with 40 percent of 18-to-34-year-olds surveyed reporting owning a wearable and 42 percent saying they have used synchronous video telemedicine. Folks 55 and older are still coming around to digital health slowly. While 84 percent of those aged 55 and older saying they trust their physician to keep their health data secure, only 19 percent trust tech companies to do the same. They are also less likely to use telemedicine (only 5 percent have used live video in the past year, and only one in 10 owns a wearable).

“Technology companies still have a long way to go in gaining the trust of one of healthcare’s largest consumer groups: seniors,” the report states. 

American Well and EarlySense have partnered to make telemedicine visits available to users of EarlySense's bed-based sleep sensor. The service is related to EarlySense Live, the long-awaited home use version of the the Ramat Gan, Israel-based device maker's signature product.

"One of the key attributes of a superior telehealth experience is how informed the physician is about the patient in front of them," Roy Schoenberg, CEO of American Well, said in a statement. "The ability of new technologies to collect and deliver patient information to the remote physician, during a telehealth consult, will have a dramatic impact on its value to patients. Companies like EarlySense are at the forefront of this evolution."

EarlySense's contact-free sensor, placed under the user's mattress, measures heart rate, breathing cycles, stress and sleep indicators. Up until now, EarlySense has mostly been used in hospitals and skilled nursing facilities. The device has been used by consumers through partnerships with companies like Samsung and iFit, but with EarlySense Live, the company is finally bringing the device into the home directly. And the partnership with American Well allows them to do so without having to worry that they are giving customers health data without a way to interpret it.

"A common question we receive from customers is what to do when they see fluctuations in their health data," EarlySense CEO Avner Halperin said in a statement. "With American Well's consumer telehealth service, Amwell, the answer is clear. Users can connect with health professionals in minutes to receive expert personalized advice. This is the next crucial step toward empowering people to take control of their health from the comfort of their home, and also provides a safety net for family members, who are able to remotely monitor their loved ones."

Users of EarlySense Live will have access to American Well doctor's via AmWell, the company's direct-to-consumer offering. According to the companies, users will be able to schedule online consultations "whenever users have questions or see opportunities to improve their sleep or general health". EarlySense Live will have a price tag of $199; it's not clear whether that includes a discount on AmWell.

American Well seems to be embracing partnerships with connected health devices as a way to stand out in the direct-to-consumer telemedicine space. The company inked a similar deal with Tytocare at the end of November.

While digital health doesn't have as big of a presence at the Consumer Electronics Show in Las Vegas as other industries, there were a fair number of wearables, apps and sensor-enabled tools showcased. There were also several partnerships announced, which you can read about here. Some have already been covered in MobiHealthNews yet didn't make their official debuts til this week, but most were new announcements to the world. Here is a list of 31 digital health tools we've rounded up from CES.

Fitness gear company Polar, which has historically been known for its heartrate-monitoring watches and chest straps, unveiled its new product: a smart clothing item called the Polar Team Pro Shirt. The sleeveless base layer shirt is embedded with heart rate-monitoring sensors that contact the wearer’s skin, eliminating the need for a chest strap or wristworn band. Wearers also have a motion-tracking sensor “pod” to place in a pouch underneath the collar to track speed, distance and acceleration. The shirt integrates with Polar’s Team Pro coaching platform, and will also integrate with Polar Flow and the company’s other wearables.

Sleep Number debuted its sensor-enabled mattress that
adjusts to movements, warms feet, nudges people over if they start snoring. It’s called the 360 Smart Bed, and it works with Sleep Number’s biometric sensor technology, Sleep IQ, to track heart rate, motion and breathing and respond in near-real time. All the sleeping activity is sent to a companion app so users can track their sleep quality over time and learn their “SleepIQ Score.”

UK-based Bodytrak showed off its in-development wearable: a pair of earbuds equipped with an in-ear thermometer to measure core body temperature during activity to give wearers physiological feedback for a range of users  – from elite athletes and members of the military to hospital patients. The data is sent wirelessly to the users’ smartphone, watch or internet hub. Mainly, it’s geared towards athletes, and the device measures heart rate and VO2 as well as speed and distance while also playing music and giving the wearer feedback. 

Smart oral care company Kolibree launched Ara, an artificial intelligence-embedded toothbrush that collects data through sensors every time the user brushes their teeth. All brushing data (frequency, duration, and brushed area) is captured in the toothbrush and synced via Bluetooth Low Energy when the companion app is running, and Ara uses deep learning algorithms from the sensors to understand individual brushing habits and help the brusher develop more accurate brushing techniques the more it is used.

Wearable maker Onitor unveiled its new weight loss program that consists of a wristworn activity tracking band, a biometric sensor-embedded clip that attaches to a chest band or sports bra, and a companion app. Data from both sources is combined along with weekly weight inputs from the user to create an exercise program and nutritional coaching advice that adapt to the users progress.      

Motiv is taking a smaller approach on fitness tracking with its new ring, a titanium-encased wearable to be worn on the finger, all day, every day, that tracks sleep, fitness (steps, calories, distance and heart rate), and is powered by a battery that lasts three to five days. People can also wear it swimming, and it comes in seven sizes. Presales are at $199.

Digital health company Qardio launched its wearable ECG monitor, QuardioCore. The medical-grade monitor lets people monitor their heart health thanks to Qardio’s proprietary sensor technology that records more than 20 million data points that stream to a companion smartphone app.  The data can be shared with medical profesionals. The strap is worn around the chest and records continuous ECG, heart rate, heart rate variability, respiratory rate, temperature and activity data, and the strap can also work alongside Qardio’s other products including their smart blood pressure monitor, a wireless scale and a the QardioMD dashboard for doctors.                                           
Garmin announced a bevy of new apps, data fields and watch faces available for users to download from third party companies via ConnectIQ, an open platform that developers can use to build content for Garmin products. The new offerings include an ETA tracker from Uber that will display information right on the Garmin wearable, a control function for Trek/Bontrager bike headlights and taillights, and a  hydration and refueling reminder and  for when Garmin Edge wearers need to refuel with GU Energy Labs gels or nuun Active Hydration.

Montreal-based Cogilex launched a new health-specific search engine called Seenso Health. Seenso works as a curator and guide to health information and provides users with “knowledge maps” of key information with a guided exploratory interface. This is the first of Cogilex’s specialized search engines they are working on.

Plume Labs showed off Flow, a smart air quality tracker designed for users to take everywhere they go. The small sensor measures dust, exhaust fumes, gases and chemicals and displays different colors to indicate the air quality around the user. The data syncs with a companion app, and Plume is working on creating a crowdsourced, real-time pollution map.

The 2breathe Sleep Inducer was introduced by father-son team Erez and Benjamin Gavish, who also make an FDA-cleared hypertension wearable called RESPeRATE. Realizing that their original wearable was making its users fall asleep, they were prompted to create the new tracking module, which people wear on an elastic strap around their torso. As they breathe, the data from the rhythm of their breath feeds into their companion app, which creates a melody to synchronize with their breathing and ostensibly guide the user to slow down their respiration and fall asleep.  

PillDrill officially showcased its medication adherence hub and companion app. The device, which launched in April, consists of a compact scanning system called the PillDrillHub that is designed to sit next to the user’s pills. When doses are due, it sends out audio-visual alerts, and the user waves their medication container (which has been affixed with a scanning tag). Each scan, or absence of a scan, notifies family members or other concerned parties with an update via a companion app.

HealthyMation, the healthcare animation studio started by experts from the Harvard Joslin Diabetes Center, gave the official demonstration of their recently launched digital diabetes prevention program, Why WAIT.  

Wearable company Misfit showed off Vapor, their new touchscreen smartwatch. The Bluetooth-enabled Vapor has music and GPS, plus activity and sleep tracking.  

Johnson & Johnson and Rest Devices announced their collaboration on a connected sleep tracking and coaching system for babies. The system, which will be fully available next month, consists of Rest’s Mimo wearable baby monitor and a companion app called Nod, which both companies built together.

Diabnext showcased its artificial intelligence tool for diabetes management. The Diabnext AI platform uses J.A.R.V.I.S. interface to connect doctors and patients, and Clipsulin, a smart connected insulin dose recorder that is compatible with a range of insulin pens, captures injection data and saved to the Diabnext AI system on either a smartphone or computer.
 
Gyenno technologies launched a Smart Spoon and Fork designed to offset hand tremors from Parkinson’s Disease and other unsteadiness-causing conditions. The devices also collect data about tremors, informing doctors and researchers as well as developing smarter algorithms to improve its performance over time.

London-based Doppel made the US debut of its “mood-changing” wearable, also called Doppel. The device is worn with a sensor placed on the inside of the user’s wrist and is synced with a companion app. Doppel emits a heartbeat-like vibration, and the user taps or strokes the device to adjust the beat to move faster or slower, purportedly increasing alertness or calming one down. It will be launched in a few months and is available for preorder.  

Navigation company TomTom launched their new app, TomTom Sports. Pairing with the companies wearable trackers, the app can track up to 12 different activity types, create dashboards for progress and competition, and syncs with third party platforms including Strava, Nike+, Endomondo, MapMyFitness and Runkeeper.

New Balance and Intel launched fitness smartwatch RunIQ, which was built in collaboration with the two companies along with Google and Strava. Runners can upload and share workouts with a global community, and the watch has built-in GPS, heart rate monitoring and is battery powered (they estimate a battery life of 24 hours with typical use and five hours with continuous GPS and heart rate monitoring). Balance also debuted PaceIQ, a set of Bluetooth wireless sport headphones made with Jabra audio hardware. The smartwatch will be $300, headphones $110 when they are available in a few weeks.

UK-based BioBeats unveiled the latest version of Hear and Now, the company’s app designed to reduce stress and improve wellbeing. The app acts as a mindfulness coach to guide users through customized breathing exercises and identify stress triggers.

Health and nutrition app company DietSensor announced the launch of its app designed to improve chronic condition management like diabetes and obesity.

Now available on Android, the app works with the sensing enabled smartphone Changhong H2, which embeds the SCiO sensor from Consumer Physics. This capability allows users to scan the cells of their food, enabling counting of proteins, lipids and carbohydrates to monitor nutrition and fitness and providing personalized nutrition and fitness coaching.

Valencell announced the launch of two new versions of its Benchmark sensor systems– one system specifically for hearables (the new version is smaller to allow for faster time to market) and one for wearables worn on the wrist and arm. Both new modules measure continuous heart rate, VO2 and VO2 max, resting heart rate, caloric burn and recovery. 

Bloomlife showed off its pregnancy-tracking wearableand companion app that helps women track and understand contractions.

Philips showed off its suite of connected health tools: The Avent uGrow digital parenting platform, which is a companion app paried with Philips' smart baby monitor and ear thermometer; Philips DreamStation Go portable CPAP device, which is designed for users to take anywhere; the connected Sonicare toothbrush and the Philips Heart Health program, which is an app-based behavior change program that pairs the Philips heath watch with mobile coaching. Philips also anounced a partnership with Daimler for the Mercedes Benz Fit & Healthy project to provide drivers with health information while driving. 

In addition to the many device launches, several digital health companies use CES (formerly known as the Consumer Electronic Show) in Las Vegas as an opportunity to announce updates and major partnerships and collaborations. Read on for the biggest non-launch health news from the show.

Lots of news from Fitbit

Wearable giant Fitbit announced a number of partnerships as well as updates to its app at CES. First, UnitedHealthcare announced that its wellness program Motion will soon offer participants the ability to use Fitbit’s Charge 2 to track activity metrics via a customized integration with Motion’s Frequency, Intensity and Tenacity (F.I.T.) program. Using the device, participants can track progress on their daily goals and earn financial incentives that can be applied towards their healthcare plan.

The company then announced three more integrations: Habit, the Campbell’s Soup-backed personalized nutrition startup that uses data from genetic tests and individual’s health and fitness goals to create tailored diet and exercise plans, will now incorporate Fitbit biometric data for each user’s plan. Indoor bicycle maker Peloton, which offers on-demand, virtual cycling classes with professional instructors available through an app (which also captures fitness metrics, workout history and offers the opportunity for competition and group classes), can now sync ride metrics directly to the Fitbit app to help riders see how cycling fits into their overall fitness goals. And Gaming company VirZoom is integrating Fitbit with its virtual reality workout – wherein users ride the company’s stationary bike with a VR headset to travel through race tracks, battlegrounds, countryside scenes in the forms of a racecar driver, tank commander or Pegasus as they pedal. Each workout will be logged in the Fitbit app as an exercise.

Finally, Fitbit also launched a new version of its Fitstar personal trainer app and new community and goal setting features to its regular app.

Samsung launches $150M fund

Samsung NEXT, the tech company’s investment arm, launched a new $150M fund to support early stage startups pursuing advanced software and services innovation. While the fund isn’t health-specific, it’s certainly open to investing in health companies, and in fact Samsung NEXT has already invested in digital health company BioBeats. It also recently opened up an office in Tel Aviv, a hotbed for digital health innovation.

LifeQ partners with Garmin, Analog, and Medibio

LifeQ, a new digital health company that uses computer simulations and continuous monitoring to study biological processes, also announced several partnerships at CES. The company partnered with Garmin to launch a joint digital health solution, partnered with Analog Devices to create new, more accurate wearable devices, and partnered with Medibio to deliver mental wellness diagnostic and management solutions to users via insurance and corporate programs.

“[CES is] a huge opportunity to stand beside global brands and talk about our vision as a company and how much of an impact we can make. We want to change the way people think about their health, and this new development is finally allowing us to do that,” Executive Founder of LifeQ Dr. Riaan Conradie said in a statement. “We can now deliver incredible insights to people about their bodies, potentially even predicting a heart attack. CES speakers are watched by millions of people so it is a fantastic launch platform for us and a great place to engage with potential partners.”

Quell adds some new features

Neurometrix, which makes the FDA-cleared pain relief wearable Quell, announced several new features for the device. Users can now calibrate their devices using the app, customize their therapy dosage, and track multiple health dimensions including pain, activity and gait. The update also adds more battery life.

Data from large sleep study published

SleepScore Labs, a joint venture announced this week between ResMed, Dr. Mehmet Oz and Pegasus Capital Advisors, LP, published data from 20,000 people who both participated in a survey and used ResMed’s S+ device to track their sleep. Some highlights: 79 percent of people get less than the recommended seven hours of sleep, women sleep longer on average (6 hours, 9 minutes per night vs 5 hours, 45 minutes for men), and 50 percent of respondents reported regularly using a mix of two or more sleep aids per night, such as prescription medications, over-the-counter sleeping pills, or herbal remedies/food supplements for sleep. See more data here.

Digital health is back behind the wheel

Health economist and Health Populi blogger Jane Sarasohn-Kahn has a nice write-up on the newest concepts for digital health built into smart cars, a perennial CES idea that has yet to manifest in a meaningful way. Concepts included a stress-sensing car from Hyundai, a research project between Philips and Mercedes-Benz, and a report from Nissan that included the health benefits of autonomous cars.
 

When Fitbit bought Pebble at the end of last year, the evidence seemed against Fitbit branching into real smartwatches: The company explicitly declined to buy Pebble's hardware business or hire any members of Pebble's hardware team. But now Fitbit CEO James Park has confirmed to The Verge that Fitbit is planning to very soon launch its own app store, a sure sign, The Verge thinks, that Fitbit is planning to launch a real, Apple Watch-competing smartwatch.

Park told The Verge that Fitbit would be basing its app store on Pebble's, since Pebble had "worked out a lot of the kinks" and that they planned to launch "as soon as possible". 

“There are so many different applications [our partners] want to write,” he said, “from fitness-related ones to pill reminder applications. And we don’t have the support in place for that right now, or any software infrastructure on our devices to run those apps.”

The Verge draws the line from Fitbit's recent acquisition of Coin to its acquisition of Pebble to this news and concludes that Fitbit is definitely planning to launch a smartwatch, and it's a pretty reasonable conclusion to reach. (Fitbit declined to comment for this story.)

On the other hand, there's still quite a bit of evidence to the contrary, starting with the fact that Fitbit didn't have any interest in Pebble's hardware assets or engineers when it acquired the company last month. 

Furthermore, Park scoffed at the idea of competing with the Apple Watch as recently as last May, when he told the New York Times that, while they would gradually add more features to Fitbit, they had no interest in being seen as a mobile computing platform. “I think one of the general knocks against smartwatches is that people still don’t know what they’re good for, so they’ve crammed everything in," he told the Times at the time.

Indeed, Park has signalled many times that Fitbit is likely to go deeper into the realm of medical devices before it branches out into non-health use cases. In a recent earnings call, he called regulated medical devices"a pretty massive opportunity". In a July 2015 interview with Forbes he was even more explicit, saying ""I don’t think it’s a dichotomy between fitness and health. I think there’s an opportunity to do both and what’s more interesting is a blending of the two. I think part of the success of Fitbit has been the fact that we’ve really tried to consumerize more health and medical-based technologies."

Park's two examples of apps that might go onto a Fitbit app store -- fitness-related apps and pill reminder apps -- suggest a direction Fitbit could be going in, creating a new device that can incorporate apps, but still has a distinctly health and fitness bent. 

Our roundup of 31 health devices at CES covered a wide range of interesting launches, but there were a number of additional devices we didn't get to. In this part 2, check out 12 more digital health devices that debuted last week at the Las Vegas tech show.

We covered BACTrack's smartphone-connected breathalyzer way back in 2013, but at CES the company introduced the next generation: a wearable called the BACTrack Skyn that can either stand alone or take the place of an Apple Watch band. Whereas the BACTrack's previous offerings allowed for periodic discrete testing of blood alcohol level, the Skyn purports to tell you how drunk you are in real time via an app on your phone or smartwatch. The device is still under development but is scheduled for a release next year -- Engadget tested it out and concluded it's at least broadly accurate.

BACTrack wasn't the only continuous BAC monitor launching at the show: A company called Milo Sensors, launching out of stealth at CES, showed off a similar wearable called Proof. Founder Evan Strenk told TechCrunch that one of the use cases of Proof is to have it give the user an alert when they're about to hit a particular blood alcohol level: say, .08, the legal limit for driving. The device can also be adapted to track other substances in the blood like lactic acid or caffeine, Strenk said.

Partners Sensoria and Vivobarefoot (they teamed up back in 2014) showed off concept sneakers that can track speed, pace and location via GPS, as well as learn and adjust to the user's stride rate and foot-landing technique. Collecting this data could be useful for creating smart shoes and apps that help runners train and improve their technique. Sensoria is also offering their sensor, the Sensoria Core, with an SDK to other apparel companies.

Kaishi is a fetal heart monitor shaped like a pig. It connects to an app via Bluetooth and allows expectant mothers to monitor their baby's heart rate and even to share the sound file on social media. Though designed in America, the app is launching initially in China. It was an audience favorite in the CES Baby Tech Awards.

FInnish company Suunto showed off a movement and activity tracker for developers called MoveSense. The idea is to deliver developers a readymade tracker for just over a hundred dollars so they can iterate on the software and algorithm sides. The company is starting with a developer beta program for 50 developers and then will likely move on to making the devices available in bulk to aspiring developers. TechCrunch has more.

Seventh Sense Biosystems showed off their Touch Enabled Phlebotomy, or TAP, device which allows for easy, painless blood draws. Although not a digital health device yet, the company told MedScape it has plans to add a digital chip that would include a Bluetooth transmitter and to seek FDA clearance for patients to use the device at home without a medical professional. This could open the door for use cases in telemedicine and remote-enabled clinical trials.

French company Leti unveiled Relax, its wearable EEG device. "Using electroencephalography (EEG) to record the brain's alpha wave activity, the lightweight headgear called Relax measures the level of relaxation with an embedded electrode system that does not require the sensors to be attached to the scalp," the company wrote on its website. "Designed to allow users to maximize relaxation, the Relax headgear provides a new dimension to wellness management in every area of life, from working to studying to exercising or simply reading or listening to music. Medical certification-ready, user-friendly, affordable and non-invasive, it lets users monitor their own level of attention and enhance mindfulness. The Relax app, which is connected to the head device, provides live tracking of alpha wave activity."

Peel-and-stick connected thermometer company TempTraq announced an update to its technology that extends the battery life from 24 hours to 48 hours. Originally announced at CES 2015, TempTraq allows parents to continuously monitor their child's temperature via a mobile app, including setting up alerts when it exceeds pre-set parameters. The thermometer can measure temperatures from 86 degrees to 108.3 degrees fahrenheit. 

Omron showed off an "ultracompact" wearable blood pressure monitor that resembles a wristwatch. It's called Zero 2.0 and it also measures activity and sleep. In light of the seeming trend in wearables toward more clinical use cases, this is one to keep an eye on. "The Project 2.0 technology will redefine what have become standard notions of 'wearable'," Omron President and CEO Ranndy Kellogg said in a statement. "Our devices are a necessity, not a novelty. Omron blood pressure monitors are medical devices that measure far more than steps or heart rate; they provide accurate insights into your blood pressure numbers."

Similarly, a Chinese startup called Lohas Tech launched something called the BioRF artery radar, a wristworn device that offers pulse wave velocity and blood pressure monitoring from the wrist. "We hope that more and more potential partners will use our technology, so as to boost medical value for wearable devices, and help make life better for consumers," Gamp Zhu, Lohas Tech's CEO and founder, said in a statement. "Now with sophisticated technology to capture the artery pulse data, we are going to focus on providing more powerful device of daily health management merging with physiological signal and artificial intelligence."

Neofect showed off the Rapael Smart Glove, a powered glove with movement and activity sensors designed to help stroke patients with their rehabilitation as a control mechanism for physical therapy games. It already has FDA clearance and connects to an Android tablet which runs the software.

Kyomed, a French start-up working on personalized medicine, and Neogia, connected healthcare wearables startup, teamed up to create a prototype called Motio HW, a connected bracelet for "preventing, diagnosing, and monitoring" sleep apnea. It uses sensors to detect actimetry, heart rate, oxymetry, and respiratory rate and then plugs those values into an algorithm.

Last November, as part of an investigative series on Apple's meetings with the FDA, we reported the company's stated plans to develop "two possible (and related) products in the cardiac space" which would require FDA clearance. In that report we speculated, based largely on a quote from Tim Cook in the Telegraph, that one of the products might be a wearable ECG built into an Apple Watch strap, similar to Kardia's mobile ECG offering.

"We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” Cook told the Telegraph. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it -- maybe an app, maybe something else.”

But there's another strong contender for something adjacent to the watch -- or, as the case may be, adjacent to the phone: headphones. And there's actually evidence that Apple has been investigating heart-monitoring earbuds for at least three years.

Apple patented health-sensing earbuds back in 2014 and Mac Rumors reported in November that the company filed an update of that patent with language that clearly refers to AirPods, the wireless ear buds Apple announced alongside the iPhone 7, meant to soften the blow of the much-maligned removal of the headphone jack. 

A few months after the original patent, a source on now-defunct gossip app Secret -- who had previously leaked Nike's plans to shut down its Fuelband division, lending them some measure of credibility -- said a health sensor would be built into the next generation of Apple's earbuds. This obviously never came to fruition.

In addition, there's Valencell's patent lawsuit against Apple, which was filed a year ago and is close to closing its discovery period. While the patents at issue in the case deal with wrist-worn heart rate sensors, Valencell is known for building heart rate sensors into its earphones and the whitepapers that the company accuses Apple of accessing under false pretenses include one called "Earbud-Based Sensor for the Assessment of Energy Expenditure, Heart Rate, and VO2 max”.

Obviously a few rumors and patents over the years don't add up to a statement of fact, but it's a number of rare glimpses into Apple that all point to the same conclusion: the company has been interested in ear-based heart rate monitoring in the past. With so much riding on the success of AirPods to justify Apple's decision to nix the headphone jack, it would be a strong way to make future generations of the peripheral more enticing. 

Samsung news site SamMobile is reporting that a new version of Samsung's S Health app is in the works, and that it will add doctor's visits, telemedicine, and symptom checker features through partnerships with American Well and WebMD.

SamMobile expects the update to launch with the launch of the Galaxy S8 in late February. The site said it's a "deep integration" which will allow users to search symptoms and diseases and make doctor's appointments through WebMD, engage in video visits through an AmWell integration, and store information from appointments including symptoms, photos, or prescriptions. The report doesn't mention whether these features will be available in all countries.

The current version of S Health is mostly a wellness play, with a fitness tracker, features for building healthy habits, and an engine for launching competitions with friends. It also includes health education content. An SDK allows developers to send information into S Health, similar to how Apple HealthKit works for iOS devices.

Over the years Samsung has tried various times to do much more with the app, though not always in all countries where it exists. Samsung's S Health app originally launched for Galaxy S III users in the UK in the summer of 2012. At the time, it received data from Lifescan’s OneTouch UltraMini/UltraEasy Blood Glucose Meter via a USB connection. It also worked with Omron’s blood pressure monitors and one of its body composition scales via Bluetooth, and similar devices from A&D.

That release never found its way to the US, possibly because of FDA clearance concerns. S Health finally launched in the US with the Galaxy S4, but rather than connecting to third party medical devices, it relied on manual entry and purported to connect to three devices from Samsung: a weight scale, a heart rate strap, and a wrist-worn activity tracker. Those devices also never launched in the US. The company also launched a gamified version of S Health called S Health Buddy in Korea.

Samsung received an FDA clearance for S Health in 2014 but never really added any features that would have necessitated the clearance (it did add features letting users track their heart rate with the phone camera). In an interview at the end of 2014, Samsung Chief Medical Officer David Rhew explained the clearance by telling MobiHealthNews that S Health, which began as a consumer fitness application, was increasingly moving into the chronic disease and medical side. The company planned to make S Health work on the enterprise side, with hospitals and physicians, and was hoping that the open developer platform will promote those innovations as well as those that are consumer focused. 

"At the core, it’s still about fitness and health and general wellbeing, but at the same time we’re exploring how we can apply this for patients that may have chronic diseases, or may be those that perhaps we need to provide other types of devices and applications that connect with the S Health application," he said at the time. "We are trying to find ways to build on it. You have to start somewhere and we started with fitness. We’re finding that the opportunities go beyond that."

Apple periodically features groups of apps in its app store for particular use cases and audiences. Under “Apps for Patients” in its Medical section, the company highlights these 24 personal care apps, which range from well known apps like WebMD and Mayo Clinic to some more under-the-radar options. Some apps apply to people living with particular conditions, while others provide lifestyle help for anyone. Read on for Apple’s 22 picks for personal care apps.

Mayo Clinic

The Mayo Clinic’s app is not just for Mayo Clinic patients, though it has more features for patients. It also offers educational content such as fitness videos, recipes, and wellness tips. Mayo Clinic patients can also get access to test results and radiology images and can even sync the app up with their Apple Watch to get appointment reminders on the wrist.

Pacifica - Anxiety, Stress, & Depression relief

Pacifica is an app that promises to help users cope with stress, anxiety, and depression using tools based on cognitive behavioral therapy, mindfulness, and relaxation. The app offers audio tools for relaxation, tracking tools to track your health, mood, and even thought patterns. The app is free, but a premium version is available for $5.99 per month.

AskMD

Sharecare’s AskMD is the digital health company’s flagship app and includes a variety of features to help users manage their health. The centerpiece is a symptom checker, but that is paired with a recommendation engine for doctors that takes into account location, insurance and specialty. Users can also use the app to track and organize their health information.

Simple Contacts 

This app, which is registered with the FDA, provides a digital eye exam for renewing contact lens prescriptions. The test, which is then reviewed by an ophthalmologist, is just designed to demonstrate whether the user’s current lenses are working, not to generate a new prescription if they aren’t. If the user can see, they can then choose and order lenses from within the app.

Iodine

Founded a few years ago by former Wired editor Thomas Goetz, Iodine helps patients learn more about their prescription drugs by facilitating information sharing. People can post about their experiences with the efficacy and side effects of different drugs, and they can search drugs and learn about them — both from others and from professional pharmacists.
 

Cures

Cures by Healtho is designed to put insights from medical journals into the hands of patients. The app lets users search for medical problems and read up on possible treatments — over the counter, prescription, and homeopathic —  so they can explore them or mention them to their doctor. It also includes tools to track symptoms.

First Aid by American Red Cross

First aid is an app designed to give users first aid advice in a crisis. It includes step-by-step advice, interactive quizzes, and video lessons. The app can be toggled between English and Spanish and allows the user to call 9-1-1 from right in the app.

MyChart 

Epic’s MyChart is the patient-facing app that goes along with its electronic health record. The app allows users to review test results, medications, immunization history, and other data. It can also connect them to their physician and help them manage their appointments. More recently, MyChart has integrated with the Apple Health app to facilitate tracking and uploading of health and fitness data.

Calorie Counter & Diet Tracker by MyFitnessPal

MyFitnessPal, which has been owned by Under Armour since early 2015, is a well-known and well-regarded app for tracking diet and exercise. It includes a database of more than 5,000,000 foods and connects with more than 50 apps and devices for tracking fitness. The app also includes a built-in activity tracker. It’s free, but the premium option costs $9.99 per month.

CareZone

CareZone is an app for organizing medical information, especially managing medications. The app allows a user to take pictures of their medications and have the names, dosages, and other details automatically detected. It also includes medication reminders and other tools for staying on top of the user’s health.

mySugr: Easy to use daily diabetes logbook

For people with Type 1 or Type 2 diabetes, mySugr helps them to track their food intake and blood glucose levels. The pro version adds coaching services and a bolus calculator, as well as reminders. The app is registered with the FDA as a Class 1 device.

MyRA

MyRA, from Crescendo Bioscience (now a subsidiary of Myriad Genetics) is an app aimed specifically at people with rheumatoid arthritis, to help them track their symptoms. The app shows a picture of a body on which the patient can record where they feel pain, when they felt it, and what they were doing. Crescendo says the data from the app can complement the company's main offering, the Vectra DA (disease activity) blood test, or a rheumatologist’s clinical assessment of the user's arthritis.

Medisafe Pill Reminder & Medication Tracker 

Medisafe’s app is part of the Israeli company’s cloud-based app system for medication adherence. Patients using MediSafe get a reminder to take their meds on their app, and are then prompted to record doses when they take them. If they don’t indicate that they’ve taken their meds, a series of friends and family members is informed who can then take action.

VueMe

From MIM Software, VueMe is a patient-facing app for viewing radiological imagery. Patients can use the app to view X-rays, ultrasounds, and MRIs transferred into the MIMcloud by their provider. The data is encrypted and password-protected.

Walgreens

Walgreens’ app includes a number of features for shoppers at the pharmacy, including some health-related ones: prescription refill, medication reminders, and even some telemedicine options through partnerships with partner MDLive.

Symple

Symple is a symptom tracking app that helps patients record their symptoms to show to a doctor later on. A user can track up to 10 symptoms at a time and rate them on a 5-point scale of intensity. Users can also import data from Apple Health, take pictures where appropriate, and record other factors like medications that might yield insight into those symptoms.

HealthSpek

The first personal health record app on the list, HealthSpek offers users a dashboard from which patients can add information that they find valuable, such as medication reminders, mammogram reminder, wearable activity information, and price transparency tools. They can also add family members and share the record with a doctor.

ZocDoc

ZocDoc’s app, which is available on iOS and Android devices, asks for a user’s zip code and insurance provider and then lists nearby doctors and their availability, as well as information including reviews from other patients. Users can then select a time to complete the appointment booking. ZocDoc also offers a check-in feature so that patients can also send over a basic medical history before they arrive instead of filling out the medical history clipboard.

PillBoxie

PillBoxie is another medication reminder app. It has an intuitive visual display that lets the user schedule a medication by dropping an animated pill into a pillbox. The reminders work even if the device is offline or asleep. At $1.99, PillBoxie is the only paid app on the list.

Mango Health

With Mango's app, users enter their medications or supplements, timing, and doses. Mango can remind patients when it's time to take their medication. It also automatically alerts them to potentially dangerous interactions between medications, or with food and drink. The app also includes a personal health journal. It’s also gamified: The app has an in-game currency users can earn by taking medications on time, and a leveling up system. By leveling and saving up, users can unlock real-world rewards with Mango's partners, including donations to charities and rewards at stores like Target.

WebMD

WebMD is famous for its symptom-checker, but the app is more far-reaching: it also includes medication reminders, habit and fitness tracking, first aid tips, a drug database, and educational content. Users can also use the app to find a nearby physician.

onPatient PHR

onPatient is the personal health record offered my mobile-based EHR company drchrono. The app allows patients to schedule appointments, see their medical records, message with their drchrono-using doctor, and see their medication and allergy lists. onPatient also integrates with Apple Watch.

Breathometer, the Mark Cuban-backed digital health startup that makes a smartphone-connected oral health sensor, has settled a suit with the Federal Trade Commission over its first product, a smartphone-connected breathalyzer. According to the terms of the settlement, Breathometer will have to offer a full refund to customers who bought the device.

The FTC says that it discovered serious accuracy problems with the breathalyzer device. Because it was advertised as a law enforcement-grade device and because consumers were encouraged to use it to determine whether or not they were safe to drive, the Commission took accuracy problems pretty seriously.

“People relied on the defendant’s products to decide whether it was safe to get behind the wheel,” Jessica Rich, director of the FTC’s Bureau of Consumer Protection, said in a statement. “Overstating the accuracy of the devices was deceptive — and dangerous.”

In addition to the initial accuracy problems, the FTC was further concerned by Breathometer's response after it became aware of them in 2014. The company first tried to fix the problem by updating the app to overestimate results, and then, when the problem couldn't be solved, discontinued the device but without telling customers or retailers why, FTC Senior Attorney Lesley Fair wrote in a blog post about the decision. It wasn't until October 2016 that the app was updated to permanently disable the breathalyzer.

Breathometer has been moving away from the Breathalyzer space for a while now, focusing on Mint, its oral health sensor. In a note to users on Breathometer's website, investor and "Shark Tank" shark Kevin O'Leary said the company chose to settle to focus on its digital health mission.

"We feel it is important to clarify that this settlement does not undermine our achievements in creating quality consumer health devices," O'Leary wrote. "We proactively stopped manufacturing Original and Breeze in 2015 prior to the FTC’s inquiry.  We stand behind our current product, Mint, and its quality and pioneering technology."

Mint measures measures volatile sulfur compounds in the breath, which are produced by anaerobic bacteria in the mouth. According to the company, these bacteria are correlated with poor oral hygiene and oral health, such as gum disease and bad breath. They recently secured an agreement to sell Mint in a bundle with Philips Sonicare electric toothbrushes.

In the rest of his post, O'Leary sought to distance the company from its past and cement its image as a more serious, mature company.

"When Breathometer was founded in 2012, our goal was to harness cutting-edge technology to deliver meaningful information about your body to you, immediately," he wrote. "Since then, we’ve evolved from a SharkTank sensation to a more mature company with a dedicated and talented leadership team with decades of collective experience in the medical device industry. We are firmly united in our effort to deliver best-in-class connected products that help everyday consumers monitor their body in meaningful ways."

In an interview with TechCrunch, Breathometer CEO Charles Michael Yim blamed the company's manufacturer for the accuracy errors, and said they will work with a better partner for Mint.

Breathometer experienced a boom in popularity after a good turn on investment reality TV show Shark Tank and ultimately did more than $5 million in sales -- which means the company could lose as much as $5 million in refunds if customers choose to take them up on the offer. In practice, the action is likely to cost the company much less.

As for the FTC, the agency shared several lessons that other companies should take from Breathometer's dangerous misstep. Fair wrote that companies should be extra careful with claims that effect safety; should make sure to test products outside of the lab, in the same conditions consumers use them; and should make sure their testing matches up with their advertising claims. Finally, companies should respond more quickly and appropriately to a problem.

"According to the FTC, the defendants’ failure to take appropriate action after learning that the device posed a public health and safety risk caused or was likely to cause substantial injury to consumers," she wrote. "That includes people who relied on the device in deciding to drive after drinking – and the rest of us on the road."

While most wearable baby monitors are designed with the intention to give parents peace of mind, some experts warn they may do just the opposite.

In a recent JAMA article, researchers outlined how the proliferation of baby wearables that monitor vital signs and alert parents of abnormalities via a companion app can cause undue alarm to parents. Moreover, the researchers point out, the devices have no evidence of medical benefits.

“These devices are marketed aggressively to parents of healthy babies, promising peace of mind about their child’s cardiorespiratory health, but there is no evidence that these consumer infant physiological monitors are life-saving or even accurate, and these products may cause unnecessary fear, uncertainty or self-doubt in parents,” Dr. Christopher Bonafide, pediatrician, safety expert and lead author of the article said in a statement.

Bonafide and his colleagues looked at five models of infant physiological monitors that have been introduced over the past two years: MonBaby, Baby Vida, Owlet, Sproutling and Snuza Pico, which take the form of smart, sensor-enabled socks, onesies, leg bands or diaper clips. The researchers noted that, despite the lack of publicly available evidence supporting the safety, accuracy and effectiveness of the devices, sales have been “brisk and the market is expanding,” with most products ranging from $150 to $300.

The researchers took issue with the fact that even though these companies are steering clear of the FDA by avoiding direct statements claiming that their products diagnose, treat or prevent disease, they often advertise their role as serving as an alert to parents when something is wrong with their infant’s health.

For example, the website for smart sock company Owlet features a statement from the company’s CEO saying they can’t promise to prevent Sudden Infant Death Syndrome, but believes notifying parents when something is wrong is helpful. Baby Vida, another sock-based pulse oximeter, recommends the use of its product every time the baby goes to sleep to alert parents if the baby stops breathing.

“There is no publicly available evidence that these baby monitors are accurate in measuring a baby’s vital signs,” David T. Jamison, executive director of Health Devices at the nonprofit research organization ECRI Institute and fellow author of the paper, said in a statement. “And since these baby monitors are not regulated by the FDA, we have to question what testing has been done to assure the safety and quality of these designs.”

Another issue was whether such monitoring is even necessary. Considering even healthy infants have occasional oxygen desaturations of less than 80 percent without consequences, the researchers worry the monitors could increase the risk of overdiagnosis.

“A single abnormal test – such as a self-resolving desaturation – can trigger a cascade of events,” the researchers write. “For example, a low pulse oximetry alarm from a consumer monitor could prompt an emergency department visit with laboratory tests, imaging studies, and hospital admission. Rather than reassuring parents, these experiences may generate anxiety and a false assumption that their infant is at risk of dying.”
 
In the short history of these devices, establishing their safety, accuracy and effectiveness hasn’t exactly been clear cut, the authors cede, but the FDA’s 2015 draft guidance on mobile medical apps should provide infant wearable companies some potential guidance. Additionally, the authors would like to see the FDA step in and take on their evolving role in digital health.

“Striking a balance between fostering innovation while providing appropriate and efficient regulation in the rapidly expanding mobile medical app market is challenging,” they write in the article. “In their 2015 guidance document on mobile medical apps, the FDA provides examples of apps that are the focus of their regulatory oversight and include ‘apps that transform a mobile platform into a regulated medical device,’ with breathing frequency monitors, apnea monitors, and oximeters among the device types listed. Based on these regulations consumer infant physiologic monitors would likely be categorized as FDA class II and subject to the 510(k) pathway that requires that the makers demonstrate ‘substantial equivalence’ to a legally marketed device.”

The authors also suggest that the clinical research community work either independently or in partnerships with these infant wearable companies to evaluate and publish the findings from scientific investigations. Until that happens, the researchers say, physicians should advise parents that the products can’t be considered helpful and are thus far potentially harmful.

“The current market of smartphone apps integrated with sensors that monitor infants’ vital signs are innovative and have the potential to improve care. However, their performance characteristics are unknown to the public and there are no medical indications for their use,” the researchers conclude. “Child and family advocates should make it clear to the FDA and policy makers that regulatory guidance and research evaluating the safety, accuracy and effectiveness of these products are needed.”