A new year is upon us, and FDA Commissioner Marty Makary is still staring down many of the same challenges that faced his ...

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

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

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

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.

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 FDA has approved a blood test to help diagnose Alzheimer's disease, and doctors explain how it works and why it can lead ...

The FDA designates ARB1002 as an orphan drug, highlighting its potential as a novel treatment for pancreatic cancer amid ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

New federal guidance is expanding testing for cervical cancer with a self-collection method. Dr. Mara Gordon speaks to NPR about why this option might become popular for screening for HPV.