The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.

And offering a fast-track to approve drugs the Trump administration views as a priority. Welcome to the new Food and Drug ...

These AI systems are already endangering public health — offering false assurances, bad advice and fake credentials — while ...

BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S.

Newsweek's AI Impact Award winners share how they measure success and guarantee outcomes: setting themselves apart in a ...

Mesoblast Limited (NASDAQ:MESO) is one of the 7 Best ASX Stocks to Buy Now. The company announced that it received 7 years of ...

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...

Over the past decade, health insurance companies have increasingly embraced the use of artificial intelligence algorithms.

The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML-Enabled ...