FDA leader talks evolving strategy for AI and machine learning validation

At a virtual meeting of the U.S. Food and Drug Administration's Center for Devices and Radiological Health and Patient Engagement Advisory Committee on Thursday, regulators offered updates and new discussion around medical devices and decision support powered by artificial intelligence. One of the topics on the agenda was how to strike a balance between safety and innovation with algorithms getting smarter and better trained by the day. In his discussion of AI and machine learning validation, Bakul Patel, director of the FDA's recently-launched Digital Health Center of Excellence, said he sees huge breakthroughs on the horizon. "This new technology is going to help us get to a different place and a better place," said Patel. You're seeing automated image diagnostics.