STAT(@statnews):The FDA says it is developing a plan to regulate medical devices that use generative AI. “The ecosystem is expecting clarity,” Rick Abramson, director of the agency’s Digital Health Center of Excellence, told STAT. “We seek to provide that clarity."

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STAT@statnews

2026.08.24 12:49

The FDA says it is developing a plan to regulate medical devices that use generative AI. “The ecosystem is expecting clarity,” Rick Abramson, director of the agency’s Digital Health Center of Excellence, told STAT. “We seek to provide that clarity."