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AI in med tech: how should it be regulated?

AI in med tech: how should it be regulated?

March 11, 2019

“Our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” wrote Gottlieb, as the FDA announced plans to evolve its policies to advance development and oversight of innovative digital health tools.

Consumers and clinicians are increasingly embracing these technologies – from fitness trackers to high-end imaging devices – which provide them with a range of valuable health information. A year on, how is the FDA’s new guidance in this area standing up to scrutiny?

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