How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations
Abstract We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy capturing key variations in clinical and AI-related features. Quantitative image analysis remains the most common application, but its relative proportion has declined recently. Over 100 devices lever...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-07-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01800-1 |
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