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Surgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices.

PMID：42849513 · 2026-10-08

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期刊Annals of surgery

年份2026-10-08

PMID42849513

摘要

To characterise the landscape of surgical artificial intelligence (AI) devices approved by the US Food and Drug Administration (FDA). 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. Con

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