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

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...

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

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

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...

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

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

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

MINNEAPOLIS — U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs ...