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

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

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of ...

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

Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA ...

(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be ...

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 ...