How Medical AI Devices Are Evaluated: Limitations and Recommendations from An Analysis of FDA Approvals

Details

Author(s):
Publish Date:
April 5, 2021
Publication Title:
Nature Medicine
Format:
Journal Article
Citation(s):
  • 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, Nature Medicine, April 5, 2021.

Abstract

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.