Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance
Abstract BackgroundArtificial intelligence/machine learning (AI/ML) has revolutionized the health care industry, particularly in the development and use of medical devices. The US Food and Drug Administration (FDA) has authorized over 878 AI/ML–enabled medical devices, reflect...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2025-07-01
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| Series: | JMIR Medical Informatics |
| Online Access: | https://medinform.jmir.org/2025/1/e67552 |
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