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

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

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

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.

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

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

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

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 ...

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

The Skincubator is a wearable designed to enable immediate, prolonged skin-to-skin care for the tiniest preterm infants in ...