Alterity plans to seek US FDA fast-track approval after posting positive phase II results for multiple system atrophy ...

In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the ...

The Dec. 18 letter stated that FDA found ... to support the claim that that spacer material is absorbed by the body." Hologic has received complaints and filed medical device reports to the ...

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...

AAT announces additional significant updates RADNOR, Pa., Jan. 29, 2025 /PRNewswire/ -- Advanced Aesthetic Technologies, Inc. ("AAT") announced today that their partner in China has obtained ...

Acceptance into the FDA's Safer Technologies Program is reserved for "medical devices that are reasonably ... take a hit as DeepSeek’s AI model claims a reduced need for microchips.

Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...

Lipnick, though, said some companies with large, diverse study cohorts claim their devices ... for medical purposes currently available over-the-counter following clearance by the FDA.

Indian medical device manufacturers are enhancing their Good Manufacturing Practice (GMP) compliance, reinforcing India's role as a trusted global supplier in the healthcare and MedTech sectors.

After more than six years of development, Angle has scored an FDA ... US for a device used to detect cancer by harvesting cells from a patient blood sample. In a statement, the UK medical device ...

"The FDA continues ... how to claim yours from the USPS. The information contained in this article is for educational and informational purposes only and is not intended as health or medical ...