Article
How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations
2025-03-14
Abstract excerpt
The recent proliferation of AI-enabled medical devices and the growing emphasis on clinical translation creates a critical need to understand the evolving scope of these technologies. We reviewed 1,016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy that captures key axes of variation in clinical and AI-related features. While quantitative image analysis remains the most common applicatio...
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Identifiers and source
- Literature Corpus work
- 06b27d80-db1a-5dd7-89e0-a958e54c2081
- DOI
- 10.1101/2025.03.13.25323924