How Medical AI Devices are Evaluated: Limitations and Recommendations from an Analysis of FDA Approvals


Publish Date:
April 5, 2021
Publication Title:
Nature Medicine
Journal Article Volume 582 Edition 27
  • Eric Wu, Kevin Wu, Roxana Daneshjou, David Ouyang, Daniel E. Ho & James Zou, How Medical AI Devices Are Evaluated: Limitations and Recommendations from An Analysis of FDA Approvals, 27 Nature Medicine 582, April 5, 2021.
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A comprehensive overview of medical AI devices approved by the US Food and Drug Administration sheds new light on limitations of the evaluation process that can mask vulnerabilities of devices when they are deployed on patients.