FDA Announces Sweeping Changes to Oversight of Wearables, AI-Enabled Devices

“The regulation of devices that use generative AI has been a topic of debate at the FDA, and it is ‘unclear how generative AI systems fit into this framework,’ said Gary Weissman, who develops and studies the regulation of clinical AI/ML technologies at the University of Pennsylvania. At least one example in the clinical decision support guidance appears to refer to a tool that would use generative AI, one that analyzes a radiologist’s written clinical findings to generate a proposed summary and diagnostic recommendation for provider follow-up.”

Read more at STAT News.