Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...

Hetlioz (tasimelteon) has been approved in the US for a few years to treat sleep disorders affecting people who are blind or ...

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

The FDA classification underscores the urgency of the situation and the potential danger posed by the contaminated products.

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

“FDA’s proposed rule, ‘Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products ...

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the ongoing research and efforts at the FDA to find ...

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

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 says it will ease regulatory requirements for certain consumer wearable health devices.

Certain people risk severe or life-threatening reactions if they consume these products, according to an official alert.