Since 2016, the Food and Drug Administration has received about 300 drug submissions that reference artificial intelligence, ...

Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...

The FDA said it disagreed with an assertion in the study that devices similar to those already marketed need to be thoroughly ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s ...

Zeta Surgical announced that the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities.

Know more about the VA and FDA's initiative to provide a safe and secure laboratory for evaluating AI technologies designed ...

FDA Commissioner Robert Califf calls it the “first intergovernmental health AI laboratory” that will test AI. The FDA ...

From left to right: Tommy Ibrahim, president and CEO of Sanford Health Plan; and Scott Gottlieb, former commissioner of the FDA and partner ... to the test — Open AI’s ChatGPT-4o, Google ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

A U.S. company is using AI as a tool to power women's healthcare by working with hospitals to access and integrate data.

SimBioSys announced that it received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...