The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a ...

Federal regulators are proposing a new, faster Medicare coverage pathway for medical devices deemed by the FDA as ...

Add Yahoo as a preferred source to see more of our stories on Google. Whoop's wearable devices measure metrics including sleep, heart rate and blood pressure. The company received a warning letter ...

Cala announced today that it received FDA clearance for its kIQ Plus next-generation wearable neurostimulation device.

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk Devices”[1] (the General Wellness Guidance), affects companies ...

Dec 3 (Reuters) - Niche fitness-tracking firms such as WHOOP are coming under increased regulatory scrutiny as technological advances blur the lines between wearable and medical devices, exposing them ...

As new consumer hardware and software capabilities have bumped up against medicine over the last few years, consumers and manufacturers alike have struggled with identifying the line between “wellness ...

The AAN has issued new guidance on wearable devices and digital apps as potential tools in neurological care, focusing on non-FDA cleared technology. Wearables can monitor physical activity, sleep, ...

Researchers have designed a wearable sensor that continuously monitors drug levels. The approach monitored drug levels for up ...

The Food and Drug Administration on Tuesday released two final guidance documents that would loosen regulations for certain types of wellness and software products. FDA Commissioner Marty Makary ...