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

Quality Improvement (379) Policy (91) Machine Learning (3303) Regulatory Issues and Medical Device Certification (13) Medical Device Adverse Events, Errors, Safety (38) Ethical, Legal, and Social Issues in AI (217)

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 (16) 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
  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;36(3):280 View
  7. Hua L, Zhao C, Yuan Z, Su H, Cai M, Ren X. Artificial intelligence in membranous nephropathy: transforming clinical management toward precision medicine. Frontiers in Medicine 2026;13 View
  8. Li J, Guo Z, Guo Y, Xiao R, Ding Y, Shi W, Liu W. The absence of full lifecycle risk management for AI-based medical devices in radiology. npj Digital Medicine 2026;9(1) View
  9. Jung S, Son K. Regulatory Approaches to Cybersecurity Risk Management for AI-Enabled Medical Device Software in Korea, the United States, and the European Union: Comparative Document Analysis. JMIR Medical Informatics 2026;14:e94846 View
  10. Arriola-Montenegro J, Ratishvili T, Kattah A. Artificial Intelligence in Peritoneal Dialysis: Applications, Algorithms, and Future Directions. Blood Purification 2026:1 View
  11. de Oliveira M, Roquette C, Matela N, Cruz C. Transparency and Explainability in Human Factors — A Systematic Review of Usability Assessment Practices for AI Medical Devices. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 2026;15(1):62 View
  12. Lynch N, Loughran R, McHugh M, McCaffrey F. Design and Expert Validation of an AI Change Management Process (AI-CMP) Assessment for AI-Enabled Medical Devices: Towards Agentic AI Change Management with Human Oversight. Design and Artificial Intelligence 2026:100101 View
  13. Sebin B, Karaman Sebin I. From model failure to system harm: operationalizing a sociotechnical pathway for healthcare AI safety. Frontiers in Artificial Intelligence 2026;9 View
  14. Rowe M, Rowe D. Radiation Oncology Device Recalls (2015-2025): Software and Artificial Intelligence as Emerging Drivers of Postmarket Safety. Practical Radiation Oncology 2026 View
  15. Tran N, Rashidi H. Artificial Intelligence as a Clinical Tool in Practice. Clinics in Plastic Surgery 2026 View

Conference Proceedings

  1. de Oliveira M. Proceedings of the 2026 ACM Interactive Health Conference. A Multidimensional Approach to Usability Engineering, Clinical Performance and Human-AI Interaction in AI-Enabled Medical Devices View