FDA Commissioner Dr. Marty Makary announced Tuesday that wearable devices providing non-medical-grade information will not be subject to FDA regulation, as the agency moves to clarify its approach to ...

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 ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Like many in the medtech industry, I was initially optimistic when FDA announced its revised guidance on wearable wellness devices. For years, the industry has called for clearer, more predictable ...

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 ...

“The FDA process is time-consuming and costly. There’s no reason to do it if your product is not going to cross the line," said Ariel Seeley, a Morgan, Lewis & Bockius partner. The explosion in recent ...

The FDA will not regulate wearable devices that provide nonmedical-grade health information, a move aimed at giving technology companies clearer guidance as AI-driven health tools proliferate, Fox ...

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 ...

Wearable devices and digital apps that are available to consumers are emerging as potential tools in neurological care. These include smart watches and fitness trackers to monitor heart rate, physical ...

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 ...