Early Recalls and Clinical Validation Gaps in Artificial Intelligence–Enabled Medical Devices
This cross-sectional study examines whether lack of clinical validation and publicly traded manufacturer status were associated with recalls of artificial intelligence–enabled medical devices that had been cleared by the US Food and Drug Administration.
Authors
- Sandro Sandri (ORCID: https://orcid.org/0009-0007-3647-0900)
- Joshua M. Sharfstein (ORCID: https://orcid.org/0000-0003-0036-6785)
- Joseph S. Ross (ORCID: https://orcid.org/0000-0002-9218-3320)
- Tinglong Dai (ORCID: https://orcid.org/0000-0001-9248-5153)
- Branden Lee (ORCID: https://orcid.org/0000-0001-5294-9304)
- Patrick Kramer
- Crystal Favorito
- Ritika Chanda
- Olivia Nasef
Institutions
- Johns Hopkins University (US)
- Georgetown University (US)
- Johns Hopkins Medicine (US)
- Yale University (US)
- Yale New Haven Health System (US)
Publication Details
- Journal
- JAMA Health Forum
- Published
- 2025-08-22
- DOI
- https://doi.org/10.1001/jamahealthforum.2025.3172
- Citations
- 3
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 1.96