How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals
Nat Med . 2021 Apr;27(4):582-584. doi: 10.1038/s41591-021-01312-x.
Eric Wu, Kevin Wu, Roxana Daneshjou, David Ouyang, Daniel E Ho, James Zou
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.
Read Full Article Here: https://doi.org/10.1038/s41591-021-01312-x