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 ...

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

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 ...

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

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...

FDA announcement of the creation of a Digital Health Advisory Committee causes a 7.2% decline in the iShares U.S. Medical Devices ETF. Digital health industry shows immense potential, driven by ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...