The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...

With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

Source: Authors’ analysis. Medical device recalls are publicly listed on the FDA website, along with the classification of the recall. To elaborate on concerns around clinical utility ...

The task force will help in solving the problems in the approval or registration of stakeholders for medical devices. The FDA will now be able to make the classifications based on the Asean ...

Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...

Improper or incomplete reprocessing of the MAJ-891 forceps/irrigation plug has led to reports of patient infections.

This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices. The memo announcing this change recognizes that the utilization of AI in devices ...

In a new analysis of AI and ML-enabled devices authorized by the Food and Drug Administration, Brewster and colleagues at Boston Children’s and Harvard Medical School found just that.

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

BUFFALO, N.Y. — The U.S. Food and Drug Administration says there are more than 900 artificial intelligence and machine learning-enabled medical devices on the market in the U.S. But as is often the ...