The FDA this week issued a draft guidance with recommendations for submitting medical devices that include AI_enabled ...

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...

The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...

Integra LifeSciences Holdings said a subsidiary received a warning letter from the Food and Drug Administration over issues identified during inspections at three company facilities.

While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...

The FDA defines a Class I recall as there being "a reasonable probability" that a recalled product "will cause serious adverse health consequences or death." “The recall was initiated after the ...

The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes. The FDA says women who are taking ...

The global advanced dermatology drug delivery devices market size was US$ 3,569.9 million in 2021. The global advanced dermatology drug delivery devices market size is forecast to reach US$ 8,785.0 ...

A recall of Impossible Foods products, a leading manufacturer of plant-based meat alternatives, has been classified as a Class II recall by the U.S. Food and Drug Administration (FDA). Newsweek ...