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

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

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

As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration. Dr. Michelle Tarver, a 15-year ...

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

Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on ...

Cerebrospinal fluid leaks, caused by tears or holes in the spinal cord, are rare and difficult to identify. Because the ...

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

Additionally, both the device and Siri language must be set to U.S. English for Apple Intelligence to work. Some of the most ...

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

With the usage of AI in medical devices, ethical concerns center on patient health data, safety, and privacy, which adds an ...

NPR's Ayesha Rascoe speaks with U.S. FDA Commissioner Robert Califf about the agency's process for regulating artificial intelligence in healthcare.