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This paper is in the following e-collection/theme issue:

Quality Improvement (363) Policy (88) Machine Learning (3001) Regulatory Issues and Medical Device Certification (11) Medical Device Adverse Events, Errors, Safety (32) Ethical, Legal, and Social Issues in AI (190)

Published on in Vol 13 (2025)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/67552, first published .
Female surgeon in blue scrubs and mask using a medical touchscreen.

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Authors of this article:

Wei-Pin Chen1 Author Orcid Image ;   Wei-Guang Teng2 Author Orcid Image ;   C Benson Kuo3 Author Orcid Image ;   Yu-Jui Yen2 Author Orcid Image ;   Jian-Yu Lian1 Author Orcid Image ;   Matthew Sing1 Author Orcid Image ;   Peng-Ting Chen1, 4 Author Orcid Image
Article Authors Cited by (6) Tweetations (1) Metrics

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  2. Nakajo M, Hirahara D, Hirahara M, Eizuru Y, Tani A, Kanzaki F, Takumi K, Kamimura K, Yoshiura T. Artificial intelligence in oncological positron emission tomography: advancing image analysis and interpretation. Clinical Radiology 2026;92:107187 View
  3. Zhang L, Yan J. Approval of AI-Based Medical Devices in China From 2020 to 2025: Retrospective Analysis. JMIR Medical Informatics 2026;14:e85538 View
  4. Nightingale A, Bird G. Industry perspective: Wearable electronic devices for remote patient monitoring. APL Electronic Devices 2026;2(1) View
  5. Rosen K, Mandl K. What FDA Clearance Does, and Does Not, Mean for Artificial Intelligence. Annals of Internal Medicine 2026;179(6):895 View
  6. Kaiser L, Wendler T, Hardiansyah D, Hellwig D, Lohmann P, Nekolla S, Papp L, Ritt P, Shiyam Sundar L, Tran-Gia J, Zatcepin A, Miederer I. Applications of artificial intelligence in nuclear medicine. Zeitschrift für Medizinische Physik 2026 View