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 Wu¹, Kevin Wu², Roxana Daneshjou^{2

3}, David Ouyang⁴, Daniel E Ho⁵, James Zou^{6

7

8}

¹ Department of Electrical Engineering, Stanford University, Stanford, CA, USA.
² Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.
³ Department of Dermatology, Stanford University, Stanford, CA, USA.
⁴ Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
⁵ Stanford Law School, Stanford University, Stanford, CA, USA.
⁶ Department of Electrical Engineering, Stanford University, Stanford, CA, USA. jamesz@stanford.edu.
⁷ Department of Biomedical Data Science, Stanford University, Stanford, CA, USA. jamesz@stanford.edu.
⁸ Chan-Zuckerberg Biohub, San Francisco, CA, USA. jamesz@stanford.edu.

No abstract available

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