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

Quality Improvement (299) Ethical, Legal, and Social Issues in AI (107) Medical Device Adverse Events, Errors, Safety (22) Regulatory Issues and Medical Device Certification (9) Machine Learning (2121) Policy (74)

Published on in Vol 13 (2025)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/67552, first published .
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

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 (2) Tweetations (1) Metrics

Journals

  1. Zhai R, Hua C. Regulatory Challenges of AI Application in Watershed Pollution Control: An Analysis Framework Using the SETO Loop. Water 2025;17(21):3134 View
  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