FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

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 ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

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 ...

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...