Fitbit plans on making waves this holiday season. That’s when the company's long-awaited smartwatch, which has faced production issues and delays, will finally be released, CEO James Park said in a second-quarter earnings call.
 
The smartwatch will offer features such as health and fitness tracking, GPS capability, water resistance up to 50 meters and compatibility across platforms, as well as a battery that’s expected to last for days -- something that is certain to draw comparison to the Apple Watch's notoriously short charge.
 
The ultimate price has yet to be revealed, but Park said it will be “attractive,” in a range carefully calibrated to lure consumers. Which is exactly what Fitbit hopes to do: Apple’s smartwatch, which ranges from about $269 to $369, has started to incorporate more health and wellness functions and might well be digging into Fitbit’s sales; Fitbit reported a 40 percent drop in its second-quarter revenue, down to about $353 million in sales. Representing a little more than 3.4 million devices, that’s half of last year’s sales.
 
Overall, Fitbit reported a loss of more than $58 million in the quarter, down 25 cents per share. At this time last year they boasted a profit of $6.3 million and were up 3 cents per share.
 
Not all the financial news was bad, however. Fitbit’s full-year fiscal forecast is now between $1.55 billion and $1.7 billion, about half a billion more than its previous forecast. It posted revenues of $353.3 million for the quarter, while expectations had placed them in about the $341.6 million range.
 
That news is encouraging for the company, which earlier this year fell to third place overall in the wearable category, behind Apple and Chinese outfit Xiaomi.
 
Exact timing for the shipping of the new Fitbit watches is uncertain; CFO Bill Zerella said in the earnings call that the “vast majority of revenue in Q3 will be related to legacy products,” indicating a Christmas season launch.
 
Along with the smartwatch will come a developer kit, which will eventually allow companies to create compatible apps. Initially, a limited number of partners, selected by Fitbit, will be able to develop those apps.
 
"It will be really exciting and interesting to see how the developer community, primarily initially from Pebble, reacts to the tools," said Park. "I think developers are going to be surprised and excited by the ease of use and simplicity of the developer tools."
 
Park expressed confidence that the new smartwatch will help the company make inroads against its competitors, and the company is already looking beyond the product’s launch, examining technologies that could track sleep apnea and other conditions.
 
“We have a firm vision of the future,” he said. “Devices are a means to an end.”
 
The U.S. proved to be one of Fitbit’s eaker markets, with revenue in the States shrinking by 55 percent to $199 million, reflecting fewer Fitbits sold -- 3.4 million devices compared to 5.7 million last year.
 
The Asia-Pacific region proved to be a much stronger market. Fitbit saw a 21 percent growth in revenue in that region over last year, $21 million total. And because of spending cutbacks on advertising and marketing, it trimmed is operating costs by about 7 percent

According to a new report by analyst firm Strategy Analytics, Chinese tech upstart Xiaomi has, for the first time, surpassed Apple and Fitbit as the world's top wearable maker in terms of shipments. Xiaomi, which competes on price, selling wrist-worn trackers for as little as $15, became the market leader with 17 percent market share to Fitbit's 16 and Apple's 13.

"Xiaomi’s Mi Band fitness trackers are wildly popular in China, due to their highly competitive pricing and rich features such as heart-rate monitors, step-counters and calendar alerts," Neil Mawston, executive director at Strategy Analytics, said in a statement. "... Fitbit is at risk of being trapped in a pincer movement between the low-end fitness bands sold by Xiaomi and the fitness-led, high-end smartwatches sold by Apple.”

It's true that the shift has at least as much to do with Fitbit's decline as it does with Xiaomi's ascendance. While Xiaomi only jumped from 3 million shipments in Q2 2016 to 3.7 million in Q2 2017, Fitbit dropped from 5.7 million to 3.4 million in the same period. Apple, meanwhile, rose steadily from 1.8 million to 2.8 million. Taken altogether those changes have led to a dramatic shift in marketshare for Fitbit, which dropped from 29 percent down to 16.

Xiaomi's accessories, including its fitness devices, became available in the US in 2015, but the bulk of the company's sales lead still comes from China. It has kept pace with the fitness tracker arms race, adding heart rate sensing, sleep tracking, and even a $102 smartwatch offering called the WeLoop.

Both Apple and Fitbit could reverse the trend, at least temporarily, when they launch highly anticipated upcoming devices. Fitbit's long-awaited smartwatch offering will be available at the end of this year, while Apple is rumored to be working on an Apple Watch Series 3.

"Apple has for now lost its wearables leadership to Xiaomi, due to a lack of presence in the sizeable fitnessband subcategory," Cliff Raskind, director at Strategy Analytics, said in a statement. "However, the rumored upcoming Watch Series 3 launch with enhanced health tracking could prove to be a popular smartwatch model and enable Apple to reclaim the top wearables spot later this year.”

The USPTO granted Apple a new patent last week that details ways the iPhone itself could be used as a health sensor to detect "blood pressure index, blood hydration, body fat content, oxygen saturation, pulse rate, perfusion index, electrocardiogram, photoplethysmogram, and/or any other such health data." This data could be gleaned from the front-facing camera, the ambient light sensor, the proximity sensor, or a special electrode built into the device.

Patents are notoriously dubious sources of information about a company's future plans. At many companies the practice is to seek patents early to keep the company's options open and mazimize the chance that they'll beat competitors to the filing -- whether or not there are actual plans to develop the offering. Additionally, patents can take a long time between filing and the patent being granted (this one was filed in 2015) and companies' plans can change in the meantime.

All that said, this patent from Cupertino is one more piece of the increasingly complicated puzzle that is Apple's plan for health devices, so it's worth considering the claims.

One aspect of the filing, the idea of using the iPhone's camera to detect pulse, is not a new idea by any means. Azumio's Instant Heart Rate app, which launched in 2011, is one of the most famous applications of the technology. But we found six others back in 2013. Using light to detect some of the other biomarkers listed in the patent, like blood pressure and blood oxygenation, is not unheard of either -- in fact standard of care fingertip pulse oximeters already use a light sensor.

The idea of using an electrode in the device to turn the iPhone into an ECG is also pretty well established, currently the domain of companies like AliveCor and Cardiac Designs. Apple could build the functionality into the phone itself. In fact, emails between Apple and the FDA uncovered by MobiHealthNews last fall included discussions of "two possible (and related) products in the cardiac space" and we speculated at the time that an AliveCor-like accessory could be one of those products. 

“Nothing would be better for AliveCor than Apple introducing an ECG device but I am very skeptical,” AliveCor inventor Dr. David Albert told MobiHealthNews in an email at the time. “The market is small in Apple terms. Most iPhone customers don't need an ECG. However, were they to introduce something, I suspect AliveCor would be acquired in a nanosecond. Alphabet, Microsoft, Fitbit, Medtronic, GE, Philips, Samsung, Huawei, Xiaomi, etc. would need a solution fast and getting into the highly regulated medical field would not be fast for any of the nonmedical companies and the medical companies take years to develop products.”

Rumors have been kicking around regarding technology giant Samsung’s new Gear Fit2 Pro, but those rumors have taken on concrete form with a leak from Venture Beat revealing a design that builds on its predecessor, the Gear Fit2.
 
The wearable fitness tracker -- which could be unveiled as soon as next month -- takes much of its physical design from the Gear Fit2, including what will likely be a curved super AMOLED display. Most of the changes will probably come under the hood.
 
The leak suggests that Samsung has made the device tougher and more durable, able to survive intense workouts thanks in large part to a watch-style clasp. It appears the Pro will also feature a built-in GPS, a Speedo On app which offers swim tracking, and offline syncing capabilities with Spotify.
 
On top of that, it’s rumored to have a 5ATM water resistant rating, as well as a yearlong subscription to Under Armour’s premium app. The water resistance is a step up from its predecessor; the Gear Fit2 was IP-68 certified for brief interactions with water, but it wasn’t submersible.
 
Analysts are speculating that the Pro takes its moniker from a fuller array of health monitoring options. Wareable suggests that Samsung might finally be deploying the sensor-packed chip it announced at CES in 2016. With that chip, the device could monitor PPG, skin temperature, galvanic skin response and body fat data.
 
Last week, the Gear Fit2 Pro appeared on a support page on Samsung’s website, and while the page was lacking in info, it was accompanied by a model number, which recently got approval from the FCC. Its unveiling may come as soon as Aug. 30.

The wearables market continues to generate a lot of attention, both positive and negative. Fitness trackers and smartwatches remain the flag bearers of the wearable market, seeing growth but at a slower pace than has been estimated, according to a new report from Tractica.
 
Meanwhile, other wearable device categories such as body sensors continue to show strong promise, driven largely by wearable patches used in healthcare applications -- which, more broadly, are expected to drive much of the momentum in the overall wearables market.
 
Tractica forecasts that annual wearable device shipments will increase from 118 million units in 2016 to 430 million units by 2022, representing a compound annual growth rate of 24.1 percent. The market intelligence firm forecasts that, by the end of that period, smartwatches will have become the largest wearable device category, followed closely by fitness trackers and body sensors.
 
Other devices, according to Tractica, will also play a role in the growth of the market, including smart clothing, wearable cameras, smart glasses, smart headphones and other wearables.
 
“Healthcare and health-focused applications in general will be a major driver for the next phase of growth in wearables,” said research director Aditya Kaul in a statement. “Wearable device companies that pivot beyond fitness and activity tracking, toward preventing and managing chronic health conditions like diabetes and heart problems will succeed in the long run. Tractica believes that chronic health management, both in a professional healthcare setting, as well as a general consumer setting, will help wearables break into the mainstream.”
 
Tractica’s report, “Wearable Device Market Forecasts”, quantifies the market size and growth opportunity for wearable devices.
 
The market data includes device shipments and revenue segmented by world region, application market, and connectivity technology. The application markets covered in this study include consumer, enterprise, industrial, public safety, healthcare, sports and others.
 
The forecast period extends from 2016 through 2022. An executive summary of the report is available for free download on the firm’s website.

If Samsung Electronics has anything to say about it, those with visual impairments will soon be able to use their smartphones to make things a bit clearer. Samsung is launching Relúmĭno, a visual aid application that works in conjunction with the Gear VR.

The app processes images from videos projected through the rear camera of a smartphone, and makes the images a little more friendly for the visually impaired. Specifically, its major features include magnifying and minimizing the image; highlighting the image outline; adjusting color contrast and brightness; reversing color; and screen color filtering.

The end effect is that Relúmĭno enables visually challenged people to see images more clearly when they are reading a book or viewing an object.

“Relúmĭno will be the life-changer for 240 million of the visually impaired people around the world and we promise a firm and continuing support,” said Jaiil Lee, vice president and head of the Creativity and Innovation Center at Samsung, in a statement.

For those suffering from a blind spot in their vision, or tunnel vision -- the loss of peripheral vision with the retention of central vision -- Relúmĭno works by remapping unseen images and placing them in the parts of the eye capable of seeing them.

When users set the sizes of a blind spot or tunnel vision for the first use, the app automatically places the blind point in the visible surrounding parts and puts images within the “tunnel,” or visible range, thereby helping users who have a visual field defect to see things better. Other visual aids offer similar quality, but Samsung is promising that Relúmĭno will be far less expensive that the competition.

Selected as a C-Lab project last May, Relúmĭno was first designed to help the visually impaired enjoy daily activities such as watching TV and reading books. (C-Lab is a startup business program that nurtures a creative corporate culture and innovative ideas among Samsung employees.) While most C-Lab projects are completed within a year, Relúmĭno will be an ongoing project of sorts, with plans to develop glasses-like products that are perhaps a bit more subtle.

In Latin, “Relúmĭno” means “light up again.”

EarlySense is known for contact-free, continuous health monitoring solutions, and its latest offering is a mouthful: the EarlySense Live Family Health Monitoring Kit with SmartShare. It’s a complex title with a simple premise -- it provides caregivers, such as parents of young children or adults caring for the elderly, with a platform to track and manage a dependent’s health. And this can be done whether said dependent is just down the hall or in another state entirely.
 
Using the same technology as the EarlySense Live, the Family Health Monitoring Kit is geared toward caregivers overseeing the health of people who don’t have smartphones. The monitoring device shares real-time health data through the EarlySense Live mobile app on the caregiver’s phone, and it measures key signals like breathing, heart rate, stress levels and sleep cycles. The goal is to encourage a more proactive approach to caring for children and aging adults.
 
To get an accurate depiction of a person’s health, the monitor uses artificial intelligence-based algorithms. The monitoring of breathing and sleep information may be of particular benefit to parents of children with asthma, allergies and sleep apnea; in fact, in a recent study led by Prof. Asher Tal, head (emeritus) and founder of the Pediatric Pulmonary Unit and Sleep Center at Soroka Medical Center, the EarlySense Live device delivered a 90 percent accuracy rate for detecting sleep apnea and disordered breathing in children. The device was also found to accurately detect apnea episodes, thus allowing for early consultation with a healthcare professional.
 
“As a father, I understand firsthand what it is like to worry about the health of your child. This sense of responsibility for another life -- whether it’s your child, an aging parent, or any other loved one -- is a common experience for most adults,” said Avner Halperin, CEO of EarlySense, in a statement. “This is why I feel so passionately about the EarlySense Live Family Health Monitoring Kit, as it will bring peace of mind to thousands of caregivers through its hospital-proven sensor technology, remote monitoring capabilities, and life-improving insights.”
 
Another benefit to the new kit and the subscription-based SmartShare service is that it puts together real-time alerts and morning data reports based on information from the dependent’s sensor. The Family Health Monitoring Kit also sends updates if heart or breathing rates cross certain thresholds set by the users, ostensibly making it easier to determine when professional consultation may be needed.
 
The device also slips underneath a bed mattress, eliminating the need for dependents to wear any sort of uncomfortable contraption.
 
Used worldwide in hospitals, rehab and skilled nursing facilities, EarlySense assists clinicians in the early detection of patient deterioration, helping to prevent adverse events -- including code blues, which are a result of cardiac or respiratory arrest, preventable ICU transfers, patient falls and pressure ulcers.

The EarlySense Live Family Health Monitoring Kit with SmartShare should be available for $199 on EarlySense.com and Amazon.com later this year. 
 

While Google the company -- now known as Alphabet -- has spun its health operations into several growing subsidiaries, Google the search engine continues to be one of the major ways people seek to learn about their health. To its credit, Google has displayed an awareness of the "ask Dr. Google" phenomenon and over the years has steadily improvedwhat people see when they make health-related search queries. Most recently, they partnered with Mayo Clinic and Harvard Medical School to provide high-quality health information.

Now the search giant is turning its attention toward depression, working with the National Alliance on Mental Illness (NAMI) to direct people who search for clinical depression on mobile devices to a clinically-validated screening test (the PHQ-9) that can help them evaluate whether they might have the disease. 

"Clinical depression is a very common condition — in fact, approximately one in five Americans experience an episode in their lifetime," Mary Giliberti, CEO of NAMI, wrote in a blog post for Google. "However, despite its prevalence, only about 50 percent of people who suffer from depression actually receive treatment. To help raise awareness of this condition, we’ve teamed up with Google to help provide more direct access to tools and information to people who may be suffering."

Providing any kind of screening tool online can be a difficult tightrope for companies that want to provide a service to casual information seekers without claiming to be a diagnostic tool, especially since false negatives present such a danger. But Google and NAMI are skirting that risk both by making the nature of the tool as clear as possible upfront and by using an existing evidence-based and clinically-validated tool.

"The results of the PHQ-9 can help you have a more informed conversation with your doctor," Gilberti wrote. "...Statistics show that those who have symptoms of depression experience an average of a 6- to 8-year delay in getting treatment after the onset of symptoms. We believe that awareness of depression can help empower and educate you, enabling quicker access to treatment. And while this tool can help, it’s important to note that PHQ-9 is not meant to act as a singular tool for diagnosis."

When a user searches for "depression," a button labeled "Check if you're clinically depressed" will appear within the existing Knowledge Graph card. Pressing that button takes the user to the questionnaire (and an assurance that the data won't be stored). Based on the results, Google will offer a score on a scale of zero to 27, along with an interpretation of that score and advice on how to proceed. Severe scores include a direct link to the National Suicide Prevention Lifeline.

Connected health device company Qardio has unveiled the next generation of QardioBase, the company’s smart scale and body analyzer which originally launched in 2015.

“We see this as an evolution,” Qardio Chief Business Officer Alexis Zervoglos told MobiHealthNews. “The original QardioBase was a product that moved the field forward and we were consistently told that, both by customers and by retailers. … We didn’t see any reason to move away from a winning formula, but we were getting a lot of feedback from customers about ways they were using it, the things we could do better, and the ways we could make it more useful and better for them.”

For one thing, the new QardioBase is slightly larger, to accommodate more sizes of feet. And the scale has been redesigned so that being on different surfaces — carpet vs hardwood floor, for instance — no longer affects the accuracy. The screen is brighter and the haptic feedback, another way the scale speaks to the user, is sharper.

There are also changes on the inside, with the sensors and algorithms updated to make the device both faster and more accurate. And the traditional alkaline battery has been subbed out for a rechargeable battery that lasts a year on each charge.

“Our objective is to be as frictionless and easy as possible,” Zervoglos. “We want people to step on, step off, and get on with their day.”

The original QardioBase has a few interesting features, and those are carried on to this device. For instance, by default the scale doesn’t actually show users their weight, but instead a smiley face that indicates whether they are making progress in the right direction toward their goals.

“A nutritionist will tell you, if you’re trying to lose weight, the worst thing you can do is look at the numbers on the scale,” Zervoglos said. “They want you to track the trends, but they don’t want you to obsess about the numbers because your weight changes every day.”

In addition to weight, the scale also tracks full body composition including percent of muscle, fat, water, bone. It uses this information to identify different users in a family and automatically upload their data to its own trend line. The scale also has a Pregnancy Mode for expecting mothers.

Qardio considers itself to be both a medical device company and a consumer electronics company. Its product suite is focused on heart health. In addition to QardioBase, the company has a smart blood pressure cuff called QardioArm and a heart monitoring strap called QardioCore. A software product, QardioMD, allows doctors to prescribe the devices to patients and receive data from them in a digestible way.

“The fact is that, in the US more so than any other country, healthcare is consumerizing,” Zervoglos said. You used to go to a doctor and have them tell you what’s wrong with you and what you should do about it. Now, more than half of patients go into the doctor because they know what’s wrong with them because they Googled it and are simply asking for a rubber stamp. There is no distinction between talking to the providers and talking to the patients. Our audience is both of them.”

QardioBase 2 is available now in the US, UK and continental Europe and will come to Canada, Australia, and Hong Kong September 18. It retails for $149.99.

IFA, a consumer electronics trade show that rivals CES for scope, begins this week in Berlin, and a number of wearables companies are taking the opportunity to announce next generation devices. At the same time, IDC has come out with its quarterly wearables tracking numbers.

IDC reports that wearables shipments grew 10.3 percent year over year, reaching 26.3 million during the second quarter of 2017. Specifically, most of that growth is in the smartwatch market, which IDC defines as wearables that can run third party apps. Those that can't, dubbed 'basic wearables', dropped just shy of one percent, while smartwatches grew 60.9 percent. 

"The transition towards more intelligent and feature-filled wearables is in full swing," Jitesh Ubrani, senior research analyst for IDC, said in a statement. "For years, rudimentary fitness trackers have acted as a gateway to smartwatches and now we're at a point where brands and consumers are graduating to a more sophisticated device. Previous niche features such as GPS and additional health tracking capabilities are quickly becoming staples of the modern smartwatch. Just a year ago only 24.5 percent of all wearables had embedded GPS while today that number has reached almost 41.7 percent."

Ubrani also noted that health and fitness are growing interest areas.

"Equally important to device features will be the algorithms tracking workouts and providing health insights," he said. "There is growing interest from the medical industry to adopt wearables and consumer expectations are also on the rise. This is where companies like Apple and Fitbit have the potential to maintain their lead as their investments in the tracking and perhaps diagnosing of diseases will be a clear differentiator from low-cost rivals."

Fitbit, of course, has just unveiled its Ionic smartwatch -- a move that seems to be in the right direction, given the trends IDC has noted.

"With the launch of our first smartwatch, Fitbit Ionic, we are delivering what consumers have not previously seen in other smartwatches: advanced health and fitness features, a highly personalized experience, industry-leading GPS, and apps and smart features – all with 4+ day battery life and cross-platform compatibility," a Fitbit spokesperson said in an email. "With the introduction of a new relative SpO2 sensor that could be used in the future to track health issues such as sleep apnea, Ionic also delivers on Fitbit’s commitment to develop innovative technologies that drive positive health outcomes, helping to transition wearables from a 'nice to have' to a 'need to have'."

New trackers, features from Garmin, Samsung, and Tom Tom

Garmin announced three new, updated devices at IFA, including a smartwatch offering. The vivomove HR is the company's first hybrid touchscreen smartwatch. It tracks activity and heart rate, and uses those sensors to provide stress tracking as well.

“When we first introduced the vívomove last year, it was geared towards customers who wanted a beautiful timepiece first and activity tracking functions second,” Dan Bartel, Garmin vice president of worldwide sales, said in a statement. “With the new vívomove HR, not only is the design as elegant as ever, the wearable technology is cutting edge. We’re the first on the market to offer a hybrid smartwatch with both wrist-based heart rate and a digital touchscreen display. And you get all of that without losing the classic, timeless look of an analog watch.”

Vivosport is the company's new fitness tracker, which includes GPS and heart rate but is slimmer than the vivomove. Finally, vivoactive 3 is the company's true smartwatch, with a fitness-focused app store and, notably, mobile payments -- a feature that the company argues is particularly useful for athletes.

"Anyone who is out and about being active can relate to the struggle of where to stash a credit card or cash, and has had to forgo a post-workout snack or coffee as a result,” Bartel said. “We’re solving that dilemma with Garmin Pay, an exciting feature on the new vívoactive 3. Use it pretty much wherever contactless payments are accepted, and give yourself one less thing to remember when you’re leaving the house.”

Samsung announced the Gear Sport smartwatch and the Gear Fit 2 Pro fitness band. Both are minor upgrades from the company's existing offerings, but they add features like water resistance and, again, in the case of the Gear Sport, NFC payment capabilities. 

Tom Tom didn't announce new devices, but added new features to its existing device line: Fitness Age and Fitness Points, two new ways for users to measure and track their fitness, and personalized workouts.

Good news for anyone who thought Fitbit's move toward the smartwatch market would be a move away from health: The wearable maker has just announced a partnership with Dexcom that will bring data from the company's continuous glucose monitor directly to the display of Fitbit's upcoming Ionic smartwatch.

Athough Fitbit's have been used in the management of chronic diseases in a number of hospital studies, the company's D2C strategy has mostly been fitness and wellness-based. However, the move shouldn't be seen as a complete surprise for either company. Fitbit partnered with Dexcom competitor Medtronic late last year, and at the time VP of Digital Health Adam Pellegrini told MobiHealthNews the deal was a sign of things to come. And Dexcom has been integrating with Apple Watch in a similar way for some time.

“The strength of our brand and our ability to track critical health metrics continuously for up to 4+ days, coupled with Dexcom’s market leadership in CGM, present a powerful combination that we hope will help millions of people better manage their diabetes,” James Park, CEO of Fitbit, said in a statement. “With Ionic, we are focused on driving positive health outcomes and more health focused tools, and this collaboration is a wonderful example of how we plan to bring that vision to our users.”

The integration will allow users of the FItbit smartwatch to display their glucose values alongside their activity tracking data on the wrist -- whether they use an iOS or Android device.

“The collaboration between Dexcom and Fitbit is an important step in providing useful information to people with diabetes that is both convenient and discreet,” Dexcom CEO Kevin Sayer said in a statement. “We believe that providing Dexcom CGM data on Fitbit Ionic, and making that experience available to users of both Android and iOS devices, will have a positive impact on the way people manage their diabetes.”

That flexibility is one way Fitbit will compete with Apple Watch, but Apple Watch has an edge on Fitbit as well. While the Ionic will still require the phone be present as an intermediary, Dexcom recently announced that the next generation of the Apple Watch will be able to display CGM readings without the phone present.

One day before another big announcement day for Apple, CEO Tim Cook has given some expansive comments to Fortune about the company's aspirations and motivations in the health space. In comments that touched on everything from the Apple Watch to ResearchKit, the tech giant CEO talked about how Apple approaches health differently than a lot of other companies.

"We’re extremely interested in this area," Cook told Fortune. "And, yes, it is a business opportunity. If you look at it, medical health activity is the largest or second-largest component of the economy, depending on which country in the world you’re dealing with. And it hasn’t been constructed in a way where the focus at the device level is making great products from a pure point of view. The focus has been on making products that can get reimbursed through the insurance companies, through Medicare, or through Medicaid. And so in some ways we bring a totally fresh view into this and say, ‘Forget all of that. What will help people?’"

In the interview, Cook discusses Apple's approach to altruism, choosing to incorporate its corporate do-goodery into the fabric of the company itself, rather than the more traditional approach of starting a foundation. He cites Apple's ResearchKit as an example of a healthcare inititative that doesn't actually generate a profit for Apple.

"We ... discovered, somewhat by happenstance out of our curiosity, that the way that research was being conducted was sort of an old-world kind of thing," he said. "People were still putting classified ads in to try to get subjects to sign up. We put out ResearchKit and made it a source so that people could run enormous-sized studies. And there have been studies in Parkinson’s and so forth that literally are the largest studies ever in the history of the world. And we’re just scratching the surface right now. There’s no business model there. Honestly, we don’t make any money on that. But it was something that we thought would be good for society and so we did it. Will it eventually lead us somewhere? We’ll find out. I can’t answer that today."

A lot has been leaked about the new iPhone announcement tomorrow, but not much so far about health or wellness. Some are betting this will be the occasion to announce the company's rumored work on replacing or augmenting the emergency health record. Cook didn't mention the announcement in his on-the-record remarks to Fortune, but it wouldn't be a Tim Cook interview without some vague hints about the company's future plans.

"There’s much more in the health area," he said. "There’s a lot of stuff that I can’t tell you about that we’re working on, some of which it’s clear there’s a commercial business there. And some of it it’s clear there’s not. And some of it it's not clear. I do think it’s a big area for Apple’s future."

Consumer electronics maker Huawei has partnered with mCareWatch, an Australian aging in place technology company, to include additional health monitoring and alert capabilities with the Huawei Watch 2. The new software would extrapolate various health data from the fitness measurement tools of the 4G sim-enabled wearable and link these data to mCareWatch’s existing app platform, as well as to other Bluetooth biometric devices.

The Huawei Watch 2 includes GPS, optical heart rate monitoring, and built-in activity-monitoring software, as well as the capacity to measure blood pressure and weight with the assistance of peripheral devices. Along with integrating these health diagnostics, mCareWatch’s software would take advantage of GPS functionality to alert family members or caretakers whenever an unwell individual stops moving or leaves designated “safe zones.” Further, the software adds an SOS Button pre-set with caretakers’ photos and phone numbers, gives medication and appointment reminders, and intermittently asks the wearer to answer a series of questions to assess their wellness.

“The Huawei Watch 2 is a quality product that addresses the need for 4G connectivity in a water-resistant watch that our clients can wear in the shower,” Peter Apostolopoulos, managing director of mCareWatch, said in a statement. “[Huawei Watch 2] complements and enhances our software, user, and connectivity requirements.”

The additional functionality contributed by the software would especially improve care for the elderly and the disabled while relieving those watching over them, Eric Zhai, managing director of the Huawei Consumer Business Group Australia, said in a statement. The Huawei Watch 2 will be the first 4G sim-enabled watch for sale in Australia, he added.

In their recent quarterly statement, IDC reported that wearables shipments grew 10.3 percent year over year, reaching 26.3 million during the second quarter of 2017. Most of this growth was in the smartwatch market. Meanwhile, competing consumer electronics company Garmin and other electronics producers announced new fitness monitoring-focused wearables at IFA this past month, while Apple CEO Tim Cook said in a recent interview that the juggernaut electronics company is “extremely interested” in the health care space.

Yesterday, Samsung also announced partnerships that would add similar monitoring software to their own Samsung Gear S2 and S3 smartwatchs. A platform developed by Reemo tracks the vitals of elderly or infirm wearers and provides a quick contact option for caregivers. Another, from Ability Wearables, is designed to monitor worker's fatigue levels, and a third Samsung Gear-based platform developed by SoloProtect focuses on ensuring the safety of solo workers who may not be able to seek help on their own. 

Among Apple’s many device and technology reveals today was an announcement that new health managing software would be built into Apple Watches. Starting Sept. 19, fitness-focused heart rate monitoring will be brought to the face of the watch, alongside warning notifications if an elevated heart rate is detected during a period of inactivity. 

The consumer electronics giant will be using this functionality to amass clinical data through a program that they call the Apple Heart Study. In conjunction with Stanford University researchers, Apple will use the sensors built into Apple Watches to observe and analyze arrhythmias. Apple has also been in conversation with the FDA about the study.

The ability of the Apple Watch to monitor heart rhythms has previously been established in a study by Cardiogram, a startup focused on that very thing. They found in May that the Watch could detect atrial fibrilation with 97 percent accuracy.

Apple COO Jeff Williams said during the company’s keynote presentation that the Watch has been “effective” in identifying irregular rhythms during the company’s internal investigations, which led them to pursue the study.

“The challenge is, many people with [atrial fibrillation] don’t feel symptoms, so it often goes undiagnosed,” Williams said today. “We’ve been looking at this for a couple years, and we think Apple Watch can help.”

Williams' assertion that Apple has been working on this for a couple years -- and the involvement of the FDA -- suggests that the Apple Watch, with this software, could be one of the cardiac devices that MobiHealthNews exclusively reported Apple was discussing with the FDA in July 2016.

Apple Watch is the most frequently used heart rate monitor in the world, Williams said, and has a customer satisfaction rating of 97 percent.

The Apple Watch’s heart rate monitor app will be updated to include resting and recovery heart rate information throughout the day. In addition, Williams broke down a redesign of the Apple Watch’s fitness software, which, along with lap timing tools for athletes, will include the ability to sync metrics by tapping the watch to other devices.

Each of these additions will be included in the Apple Watch OS4 update, scheduled for Sept. 19, 2017. The company also announced the new iteration of their smartwatch, Apple Watch Series 3, which will be released on Sept. 22 at a cost of $399 with cellular service and $329 without.

Researchers at Harvard Medical School have built a point-of-use food allergen detector that fits onto a keychain and can conducts tests in under ten minutes.

The prototype device costs less than $40 to produce, and in restaurant settings could detect major antigens at sensitivities well below the regulatory limit. While the sensitivity and ease of the integrated exogenous antigen testing (iEAT) system could be of use to clinicians and food industry regulators, the researchers noted its particular appeal to on-the-go consumers often forced to carry emergency epinephrine and maintain strict food avoidance.

“Many existing analytical methods and devices for food testing are designed for sophisticated laboratory rather than consumer use and rely on complex equipment, infrastructure, and advanced training,” they wrote in the journal ACS Nano. “Consumer devices, on the other hand, are often slow, insensitive, or have other limitations … Moreover, their relatively low sensitivity, caused by insufficient brightness of signal-intensity reporters, may result in false negative results.”

The full system consists of an electrode chip, a disposable allergen extraction kit, and a pocket-sized detector that interfaces with a smartphone and can connect to cloud servers. Each assay costs less than four dollars, although the researchers wrote that costs for the entire system could decrease with scale-up.

In the study, researchers optimized the iEAT system to detect five major antigens found in peanuts, hazelnuts, wheat, milk, and eggs. After observing strong correlation between the iEAT system’s results and those of industry-standard enzyme-linked immunosorbent assay (ELISA), the researchers tested the novel system’s sensitivity using various consumer food products and foods purchased from restaurants.

iEAT detected allergens at sensitivities substantially lower than the standard regulatory limit, and in particular identified multiple cases in which the antigen levels of menu items labeled as “gluten-free” exceeded the 20 mg/kg regulatory limit.

“The device could have many interesting applications, such as verifying food origins, confirming the absence of contaminants, or supporting dietary restrictions for religious purposes,” the researchers wrote. “Irrespective of the specific application, we envision that the portable iEAT technology will allow for more rigorous and evidence-based analysis of food products, enhance consumer protection, reduce accidental allergy exposure, and identify problems in our food supply chain.”

iEAT offers a low-cost alternative to the Nima brand’s smartphone-connected allergen detectors. Currently, the company sells a starter kit that includes the device and three one-time-use test capsules for $199.

Engineers participating in a hackathon last weekend demonstrated an artificial intelligence that they say could someday detect cancerous moles, TechCrunch reports. Although the program is currently in its infancy, the team hopes that enough user submissions could allow Doctor Hazel to predict skin cancer with at least 90 percent accuracy.

After one day and thousands of image downloads, the AI is identifying cancer at an 85 percent success rate, the team said during a presentation at TechCrunch Disrupt’s San Francisco 2017 hackathon. However, the team has launched a beta and is inviting users to submit their own photos to improve Doctor Hazel’s performance.

“There’s a huge problem in getting AI data for medicine … no one wants to share,” Mike Borozdin, developer of Doctor Hazel, told TechCrunch. “But amazing results are possible. The more people share, the more accurate the system becomes.”

Doctor Hazel gauges 8,000 variables when viewing a sample to determine whether the image is of a mole, melanoma, another type of cancer, or nothing. The team plans to have an app accompany the platform, as well as an image capturing device that could someday be made available for sale.

A fraught, crowded field

Apps, mobile platforms, and camera devices designed to evaluate moles and estimate skin cancer risk have a long history filled with successes and failures.

In 2011, the Skin Scan app launched with claims of melanoma detection using only the iPhone’s camera, and rebranded as SkinVision in 2012. That same year, University of Michigan Health System physicians launched UMSkinCheck featuring reminders and instructions for patients to self-examine their moles and skin lesions over time. Then, in 2014, experts built upon nearly a decade of  image classification research to develop DermoScreen— an app that along with a $500 dermoscope was able to detect 85 percent of melanoma cases.

However, the need for rigorous validation became more apparent in early 2015, when the Federal Trade Commission took actionagainst the melanoma detection apps MelApp and Mole Detective. The FTC alleged that the marketers of both mole photography-based apps “deceptively claimed the apps accurately analyzed melanoma risk,” and that the marketers had insufficient evidence to make these claims.

Regardless, several apps and technologies targeting skin cancer detection have come to the forefront in the years since. Oregon Health and Sciences University researchers developed a ResearchKit study called Mole Mapper in 2015, which encourages users to track the growth of any moles using their smartphone camera and a dime for scale. Last year iDoc24, which does business as First Derm, launched a smartphone-connected dermatoscope that, through a companion app, sends pictures of users’ moles to a dermatologist for clinical evaluation.

A similar format is also employed by SkinVision, who since rebranding has received funding from Leo Innovation Lab as well as CE-certification. Weeks ago, VisualDx announced that its app — designed to support non-dermatological physicians by quickly categorizing skin images — would debut in Apple iOS 11. But perhaps Doctor Hazel’s most direct and recent competition comes from Stanford’s Artificial Intelligence Laboratory, which earlier this year released a study describing a convolutional neural network that matched the performance of 21 board-certified dermatologists. The Stanford researchers said that they hope to bring their platform to smartphones and the general population.

Basic health information and advice provided by the Mayo Clinic is now available on Amazon Alexa-enabled devices. Owners who have downloaded the Mayo Clinic First Aid skill (Amazon’s version of apps) need only voice their concerns to receive answers to dozens of everyday health issues or other self-care instructions.

“Mayo Clinic produces trusted, evidence-based health guidance to empower people to effectively manage their health,” Dr. Sandhya Pruthi, general internal medicine physician and associate medical director at Mayo Clinic Global Business Solutions, said in a statement. “This is the first health guidance skill Mayo Clinic has developed and launched for Amazon Alexa. Voice-enabled experience is a new and growing channel for reaching people and delivering information they are seeking, whether or not they have an existing relationship with Mayo Clinic.”

Users may open the voice-driven platform to access and browse a listing of common health topics. Otherwise, vocally addressing Alexa with the name of the skill and a specific question will prompt a spoken response from the device.

The Mayo Clinic First-Aid skill does not replace medical care and should not be used in emergency situations, the provider cautions. It joins the clinic’s other Amazon Alexa service, Mayo Clinic News Network, which offers listeners a 60-second daily presentation with easy-to-understand health tips.

But the Mayo Clinic is not the only provider of health info in the Amazon Alexa ecosystem. This March, WebMD launched their own integration with the platform to provide users information on a range of health-related topics such as conditions, medication, tests, and treatments. Users of the WebMD skill can have the information read to them aloud, or sent as text to their Alexa app.

"There are a number of reasons that voice-enabled interfaces are growing in popularity — they are generally hands-free, people can talk faster than they type, and when done right, they make it easier for consumers to quickly and easily get to the information they need,” WebMD Vice President Ben Greenberg, whose product team developed the new voice capabilities, said in a statement accompanying the launch.

Other voice-assisted health services available on Amazon Alexa include Fitbit integration, Boston Children’s Hospital’s KidsMD skill, and Healthtap’s Doctor AI diagnosis tool.

When we broke the news in July of the shutdown of Pact, a startup that aimed to motivate users to go to the gym with monetary carrots and sticks, we noted that the reasons for the company's demise weren't readily apparent. Now a new missive from the FTC (first spotted by Gizmodo) is shedding some additional — and, truth be told, not very flattering — light on that story.

While users were promised monetary payouts for completing their workout goals and fees for missing them, Pact seems to have let a lot of users down on both ends of the bargain, with the FTC fielding complaints from "at least tens of thousands of consumers" who claimed "that they were charged rather than paid for completing pacts," according to the commission's blog. 

The complaints mostly seem to be from users who, for whatever reason, weren't able to log workouts that they completed, and were charged despite filing complaints with Pact. Others tried to cancel their accounts or even delete the app, but kept getting billed.

“Consumers who used this app expected the defendants to pay them rewards when they achieved their health-related goals, and to charge them only when they did not,” Tom Pahl, acting director of the FTC's Bureau of Consumer Protection, said in a statement. “Unfortunately, even when consumers held up their end of the deal, Pact failed to make good on its promises.”

The settlement with the FTC requires Pact to pay $948,788 back to individuals who were unfairly charged. The full judgement — for $1.5 million — has been suspended based on the defendant's financial condition. The refunds will be delivered via the users' PayPal accounts, and Pact will be required to pay the full amount if it's found to have misrepresented its financial status.

According to the commission, Pact is up on two different charges: a larger umbrella charge of "unfair and deceptive practices" under the FTC Act, and a more specific charge of violating the Restore Online Shoppers Confidence Act (ROSCA). This act deals specifically with so-called "negative options," where customers are billed for a product or service on an "opt out" rather than "opt in" basis.

MobiHealthNews has been covering Pact since it first launched in December 2012 under the name GymPact, and we were the first to break news of the app shutting down this summer.

It's unclear to what extent, if at all, the FTC judgement was the cause of the company's shut down. Considering that the judgement was suspended because of the company's financial hardship, it seems likely that Pact was already in trouble even before the investigation. As before, we've reached out to the Pact team for comment and will update this story if we hear back.

While health apps often think of the FDA as the primary agency they answer to, the FTC has gone after companies in the digital health space with some regularity over the years, including a smartphone breathalyzer, a "vision improvement app," a blood pressure app, two mole analyzer apps, a brain training game, and mobile EHR Practice Fusion. Last year the FTC even created a tool for health app makers to help them understand what regulations they're subject to.

Patients deciding the next step of their care may soon be doing so with the help of an AI on their phone. Today, Insightin Health — a Gaithersburg, Maryland-based company that develops a data-based clinical decision-making platform — announced that it has launched a consumer-facing version of its machine learning-based service, which presents all of a user's health data and future options via a text-based chatbot.

The In360 app will offer users real-time access to streamlined data collection and personal decision-making tools. The platform incorporates users’ behavioral trends to make predictive recommendations and gauge care options, while presenting the information in a straightforward way that Insightin CEO and founder Enam Noor says provides an edge over competing services.

“There are many good consumer facing apps out there that are great, but as a consumer I may need several of these to manage my care, and they are likely unconnected,” Noor told MobiHealthNews. “Our user friendliness comes from our simple, intuitive design, and simple user interface.”

More specifically, the app condenses several aspects of paying for and receiving care in a way that is easy to understand, and then begins planning the next best option in a way that reflects the user’s tendencies.

“When a patient visits a doctor, pays a bill, schedules a preventative screening, claims a reward, or provides a quality rating, In360 gathers [information], connects the data, and provides the consumer with the next steps along their path to wellness,” Noor said. “The way people interface with their health insurer, doctor, or wider care team is changing, and we offer a multi-channel experience that is preference driven, and that alone makes the consumer more apt to engage because they are in control.”

In360 is available to consumers through an app or web browser, and Noor says that the app will eventually allow users to voice chat with the AI bot. The app is fully integrated with Insightin Health’s larger platform, which is marketed to health plans as a means to examine member acquisition, retention, engagement, and competitive analysis. In360 is the first of several consumer-facing features that will be launched as part of Insightin’s platform.

“The overarching goal we are solving is to empower the [consumers] to be healthier by engaging in preventative care with knowledge,” Noor said. “Healthier outcome for the member is a win-win for both the member and health plan.”

Garmin’s upcoming effort to woo younger customers will have the support of some big brands, as the company announced today that its vivofit jr. 2 wearable activity tracker will prominently feature Minnie Mouse, Captain America, and other Disney licensed characters.

“Disney is committed to creating healthier generations, and we’ve worked with Garmin to make healthy living fun with a wearable product featuring the characters and stories we know kids love,” said Josh Silverman, executive vice president, global licensing, Disney Consumer Products and Interactive Media, said in a statement. “By combining Garmin’s expertise in wearable technologies with Disney storytelling, we’re entering a category with the potential to influence the way kids stay active.”

The new $99.99 device builds upon the core features of its predecessor — namely, daily activity counters, a point-reward system, one-year battery life, a waterproof design, and a connected smartphone app. While there are some new hardware features, such as a color screen, Garmin’s most prominent hook is the Disney-themed games and rewards that children will receive upon meeting daily goals.

“[These fitness features] paired with the Disney stories and characters that have really captured the heart of children, and adults, around the world … bring to life the possibilities and engagement that our kids can have with this concept,” Kelly Hancox, director of business development and strategic partnerships at Garmin, told MobiHealthNews. “In the US we have a childhood obesity epidemic that we have got to fight on all fronts. I think that having those products out here for parents and kids to be engaged with can help contribute to building those healthy habits for kids.”

Hancox explained that children who complete the American Heart Association’s recommendation of 60 minutes of active time daily will unlock a Disney brand-specific game within the companion app housed on a parent’s smartphone. These “adventures” are set in the Marvel, Star Wars, and traditional Disney universes, and will have players exploring a nonlinear map and meeting familiar characters. In addition, kids will unlock badges and other icons with their progress that can be displayed on the watch’s customizable digital face.

The platform’s modules and character-adorned bands are interchangeable, meaning that children can swap out their bands with those featuring another Disney brand to unlock a new adventure map and icons in the app. This means that the new mobile app, games, and accessory bands are also available for owners of the first generation vivofit jr. who purchase a new band for $29.99 — although certain features such as the social Toe-to-Toe competitive step challenge and reminder alerts are only available with vivofit jr. 2. On the other hand, parents whose children have completed their included adventure might be on the hook for another band to keep their kids moving and stave off attrition.

Although the games are primarily designed to appeal to children, Hancox stressed that the platform is designed to engage parents as well. Because children’s daily goals are handled through the phone app, it’s up to the parents to set challenges for their children; assign “reward coins” when certain tasks (including chores) are completed; and monitor their child’s steps, sleep, and schedules. If a parent is so inclined, Hancox noted, the software is compatible with Garmin’s ConnectIQ apps and supports family-wide fitness challenges using other Garmin wearables.

“This product is for the parent to purchase for their kids, and then to have that joint experience together.” Hancox said. “I think that having the responsibility element of having the chores, being able to provide the rewards and have that experience and incentive for kids to be active 60 minutes a day, and also making it fun and empowering the kids to manage their chores and responsibilities around the house [makes this] a great parenting tool that can bring parents and kids together.”