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

Nature Medicine
Volume 27 Issue 4, April 2021
https://www.nature.com/nm/volumes/27/issues/4

 

Comment | 05 April 2021
How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals
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.
Eric Wu, Kevin Wu & James Zou