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

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

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

“It’s essentially a place where you get rapid but effective evaluation — from FDA’s standpoint and from VA’s standpoint — on a potential new application of generative AI to, number one, make sure it ...

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

Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...

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

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

Revenue Rose to $8.2 MillionCompany Reaffirms Timeline for Regulatory Submission to U.S. FDAQ3 2024 OverviewResearch & Development Revenue ...

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 ...

Biotech firm Iambic Therapeutics unveiled on Tuesday what it says is a breakthrough artificial intelligence model that could ...