This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
On Nov. 6, the Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) convened to discuss the promise and evolving challenges of Generative Artificial Intelligence ...
Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of ...
In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or death ...
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