FDA Approval of Artificial Intelligence and Machine Learning Devices in Radiology
This sytematic review examines US Food and Drug Administration (FDA) premarket clearances for artificial intelligence and machine learning devices in radiology with emphasis on testing.
Authors
- Shinjini Kundu
- R. Sivakumar (ORCID: https://orcid.org/0000-0002-2122-8624)
- Brian Lue
Institutions
- University of California, San Francisco (US)
- Washington University in St. Louis (US)
- Mallinckrodt (United States) (US)
Publication Details
- Journal
- JAMA Network Open
- Published
- 2025-11-07
- DOI
- https://doi.org/10.1001/jamanetworkopen.2025.42338
- Citations
- 4
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 2.62