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

Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.

The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...

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

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FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical ...

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.

FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but two lawsuits over the final rule ...

The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe ...

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 case with ...

In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...