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

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

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...

The U.S. Food and Drug Administration (FDA) announced on Tuesday that it will limit regulatory oversight of wearable devices ...

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

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...

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

Torous noted that over the summer, a company called WHOOP received an FDA warning letter over a product that could measure ...