AdvaMed: FDA Should Oversee Health AI, But Narrow ‘Device’ Definition

By Luke Zarzecki / May 20, 2024 at 3:44 PM
Leading medical device industry group AdvaMed says FDA should remain the government entity charged with overseeing health care uses of artificial intelligence (AI), but urged the agency to narrow its definition of which AI tools qualify as a device to capture fewer clinical decision support (CDS) software tools used by providers and health systems. The organization also says CMS should develop an approach to pay for AI uses in health care, specifically clinical analytical services regulated by FDA, so that...


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