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

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

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

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...

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.

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

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 ...

Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical ...