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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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学術誌Annals of surgery

年2026-10-08

PMID42849513

抄録

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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