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

The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...

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 ...

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.

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.

Torous noted that over the summer, a company called WHOOP received an FDA warning letter over a product that could measure ...

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 ...

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...

The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.