In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
Companies like Kohler and Throne have introduced toilet cameras that analyze your bowel movements and urine to gather ...
Wearable data collection devices, combined with artificial intelligence, may help clinicians detect complications earlier and improve patient care.
A new wearable technology could change how unborn babies are monitored at home. Ph.D. researcher Yijing Zhang (Department of ...
IT TO IMPROVE YOUR HEALTH. WHETHER IT’S ON YOUR WRIST, YOUR FINGER, OR YOUR PHONE, HEALTH TRACKING DEVICES ARE SURGING IN POPULARITY, WITH USERS WANTING A DEEPER UNDERSTANDING OF THEIR WELL-BEING.
FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
Miniaturization and weight reduction of medical wearable devices for continuous health monitoring such as heart rate, blood oxygen saturation, and sweat component analysis remain major challenges. In ...
Bernard Ross, CEO of Sky Medical Technology, outlines how the NHS can ease pressures in chronic wound care management.