Only 5.1% of 314 FDA-cleared surgical AI devices had prospective evidence, a review of approvals found
Researchers screened FDA-cleared AI and machine learning medical devices up to July 2025 and found that 314, about a quarter, had surgical applications. Most were imaging-based tools for general, orthopaedic, neurosurgical or cardiac surgery, and nearly all were descriptive or diagnostic rather than predictive or…
Annals of Surgery
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