Employees at the Food and Drug Administration’s medical device center on Tuesday received notice that they would be cut amid massive layoffs at federal health agencies. The reductions included people ...

CDRH says fewer than half of the postmarket studies required of the device industry as a condition of approval are completed in the proper time frame. Although industry is not accepting those findings ...

The sudden firing of Food and Drug Administration employees over the weekend is already affecting medical device submissions. The cuts could delay the time it takes to bring new products to market and ...

In what the FDA described as a “transformative year” for its Center for Devices and Radiological Health, the agency set a new record in issuing green lights to innovative medical devices and ...

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) for almost 15 years, has announced that he will leave FDA later this year, ...

Last week, the outgoing leader of the FDA’s devices center, longtime chief Jeff Shuren, M.D., endorsed acting head Michelle Tarver, M.D., Ph.D., on a stage in front of the medtech industry, saying she ...

AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at $10.31 billion in 2023, is forecasted to reach $14.92 billion in 2024 and ...