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

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

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 ...

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.

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

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

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...