Clearance by the Food and Drug Administration means Minnesota Medical Technologies can now sell its fecal incontinence ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

FDA rehires staff to its medical devices division after mass layoffs Around 180 FDA medical device workers were laid off this month by Elon Musk's Department of Government Efficiency.

On January 7, 2025, during the last few weeks of the Biden Administration, the U.S. Food and Drug Administration (FDA) issued a final guidance for medical device manufacturers on notifying the FDA ...

Health in Pennsylvania FDA rehires medical device staffers fired only days earlier Published: Feb. 24, 2025, 2:32 p.m.

SBOMs And The Future Of Medical Device Cybersecurity Compliance and regulations can support product development in a positive way. The FDA mandate fits in this category.