2021•Nature MedicineRequires access

How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals

Eric Q. Wu, Kevin Wu, Roxana Daneshjou, David Ouyang, Daniel E. Ho, James Zou

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Key concepts: Food and drug administration, Drug approval, Medical device, Medicine, Risk analysis (engineering), Drug, Pharmacology, Biomedical engineering

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How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals — Research Paper | ScholarLens