FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical ...
This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
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