How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals-Reference-Cited by-同舟云学术

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

Published:2021-04 Issue:4 Volume:27 Page:582-584
ISSN:1078-8956
Container-title:Nature Medicine
language:en
Short-container-title:Nat Med

Author:

Wu Eric,Wu Kevin,Daneshjou Roxana^ORCID,Ouyang David,Ho Daniel E.,Zou James^ORCID

Publisher

Springer Science and Business Media LLC

Subject

General Biochemistry, Genetics and Molecular Biology,General Medicine

Link

http://www.nature.com/articles/s41591-021-01312-x.pdf

Reference18 articles.

1. Liu, X. et al. Nat. Med. 26, 1364–1374 (2020).

2. Norgeot, B. et al. Nat. Med. 26, 1320–1324 (2020).

3. Cruz Rivera, S., Liu, X. & Chan, A. W. et al. Nat. Med. 26, 1351–1363 (2020).

4. U.S. Food & Drug Administration Center for Devices and Radiological Health. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514737.pdf (October 2017).

5. U.S. Food & Drug Administration Center for Devices and Radiological Health. https://www.fda.gov/media/145022/download (January 2021).

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