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Peer-reviewedCC BY 4.0JAMA Network Open

Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway

  • Maria Zogka1
  • Melissa Amyx1,2
  • Philippe Ravaud1,2,3
  • Viet-Thi Tran1,2
  1. 1Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France
  2. 2Centre d’Epidémiologie Clinique, Assistance Publique–Hôpitaux de Paris, Hôpital Hôtel Dieu, Paris, France
  3. 3Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City, New York
Open at sourceDOICite

Abstract

This cross-sectional study investigated characteristics and reporting of updates to artificial intelligence (AI)/machine learning–based medical devices cleared through the Food and Drug Administration (FDA) 501(k) pathway.

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Cite

BibTeXRIS
BibTeX
@article{zogka2026updated,
  title = {{Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway}},
  author = {Maria Zogka and Melissa Amyx and Philippe Ravaud and Viet-Thi Tran},
  journal = {JAMA Network Open},
  year = {2026},
  month = nov,
  doi = {10.1001/jamanetworkopen.2026.41071},
  url = {https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2856263},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway
AU  - Maria Zogka
AU  - Melissa Amyx
AU  - Philippe Ravaud
AU  - Viet-Thi Tran
PY  - 2026
DA  - 2026/11/05
JO  - JAMA Network Open
DO  - 10.1001/jamanetworkopen.2026.41071
UR  - https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2856263
AB  - This cross-sectional study investigated characteristics and reporting of updates to artificial intelligence (AI)/machine learning–based medical devices cleared through the Food and Drug Administration (FDA) 501(k) pathway.
SN  - 2574-3805
ER  -