Hong Kong-based startup PanopticAI has obtained regulatory approval in the United States for its contactless pulse rate measuring application.
It received the US Food and Drug Administration's 510(k) clearance for the PanopticAI Vital Signs app on iOS devices.
Based on PanopticAI's proprietary remote photoplethysmography (rPPG) algorithms, the app transforms the cameras of iOS devices into medical-grade pulse rate monitors. It analyses subtle colour changes in the user's skin to measure their pulse rate in 30 seconds.
The app – touted as the first US FDA-cleared software-as-a-medical device in Hong Kong – has been used by major healthcare companies, including IHH Healthcare's Gleneagles Hospital, health and beauty chain Mannings, and global health insurer Bupa.
"This clearance… is the first of several anticipated approvals," said PanopticAI CEO and co-founder Dr Kyle Wong in a statement.
Almost two years ago, PanopticAI received seed funding from Alibaba Hong Kong Entrepreneurs Fund and Gobi Partners to secure regulatory approvals abroad.
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Just last month December, the US FDA also awarded a 510(k) clearance to a similar rPPG-based mobile app for measuring pulse rate, the Informed Vital Core app by Arizona-based Mindset Medical.
Other PPG-based mobile applications have been developed and introduced across Asia-Pacific over the past few years. In 2022, the National Taiwan University Hospital released RhythmCam, which has been approved by the Taiwanese Ministry of Health and Welfare. In India, MFine has developed a mobile app that measures various vital signs, including blood pressure and glucose levels.
A heart monitoring ring from South Korea – Sky Labs'CART-BP– also uses a PPG sensor to screen for irregular pulse waves in a user's finger.