aceSurgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices
Objective To characterise the landscape of surgical artificial intelligence (AI) devices approved by the US Food and Drug Administration (FDA). Background AI has the potential to improve surgical pathways, offering capability across screening, diagnosis, decision support, and intraoperative care. Despite this, real-world adoption remains limited. Regulatory approval serves as a key step in clinical translation but is influenced by challenges in evidence generation, safety, bias, transparency, and implementation.…
Few cleared surgical AI devices have strong prospective validation, and many cleared through 510(k) show high predicate-creep risk, which weakens confidence that they are equivalent to earlier devices.
The analysis covers devices cleared up to July 2025 and describes evidence quality and predicate-creep risk, not demonstrated patient outcomes, so the real-world effect of these gaps is not established.
Evidence
- Peer-reviewedAnnals of Surgery2026-10-08
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Truvace Impact Record TRV-2026-1693, v1: “Surgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices.” Truvace, 2026-10-17. /record/TRV-2026-1693 (accessed at citation time). sha256 3bf6b69fc4c35ef9…
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