The FDA this week issued a draft guidance with recommendations for submitting medical devices that include AI_enabled ...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The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...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.