The Perimeter B-Series OCT system combines proprietary AI technology with optical coherence tomography, for use during breast ...

BD (NYSE: BDX) announced today that investigators treated the first patient in a study of its GalaFlex Lite scaffold system.

BEDFORD, Mass., March 11, 2025 /PRNewswire/ -- Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently ...

Imricor said six of these are the company’s products, which are undergoing the US Food and Drug Administration’s (FDA’s) premarket approval (PMA) process, with an additional third-party ...

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore potential rulemaking opportunities to tighten or ...

Proposals to eliminate the self-affirmed GRAS pathway have sent shockwaves through the food industry. But what do they mean ...

the Food Additive Amendment included a provision that enabled substances that are “generally recognized as safe” to be exempted from undergoing the FDA’s typical pre-market approval process.

Shares of 2seventy bio took flight Tuesday after the biotechnology company agreed to be acquired by partner Bristol Myers Squibb. Bristol Myers is paying $5 a share in cash for 2seventy, a 79% premium ...

“Our resources are now focused on the completion of the FULCRUM-VT Pivotal IDE trial and subsequent premarket approval of the VT Cryoablation System with vCLAS™ catheter from the U.S. Food and Drug ...

However, supporters of the food additive industry argue that all ingredients are tested with the same rigor as additives that go through the pre-market approval process.