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," ...

CapsoVision, a medical device developer, submitted an application Nov. 6 to the FDA requesting breakthrough device designation for its CapsoCam UGI capsule, aimed at detecting early-stage pancreatic ...

WHITE BEAR LAKE, Minn. (FOX 9) - A Minnesota-based medical device company is on the verge of transforming how hearing is ...

The U.S. Food and Drug Administration (FDA) is warning consumers, patients and health care providers about the potential risk ...

RF microneedling has become a popular treatment in recent years. "It can effectively reduce the prominence of fine lines, ...

The Food and Drug Administration sent a warning letter to Philips last month due to quality violations found at three of its ...

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...

Recent drug device recalls include Olympus endoscope needles, Abiomed heart pump controllers, and Teva blood pressure drug over cancer risk.

Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release. Dr.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) WASHINGTON (AP) — Barely a week after mass firings at the ...