The FDA 510(k) clearances for cardiac procedures cover Intuitive's latest-generation da Vinci 5 (DV5) using non-Force ...

The post The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers appeared first on Reason.com.

In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...

On Wednesday, radiology AI company Aidoc announced the FDA has cleared a tool that can triage 14 critical findings in a ...

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...

This roundup highlights recent FDA updates related to drug approvals and devices used by optometric eye care professionals.

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...

We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of ...

This story was originally published by ProPublica. The FDA rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it's sometimes unable to make sure ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

Forbes contributors publish independent expert analyses and insights. Dr. Lance B. Eliot is a world-renowned AI scientist and consultant. In today’s column, I examine the recently published FDA ...

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...