PubMed

泌尿科における人工知能：米国食品医薬品局（FDA）認可済み装置のレビュー。

PMID: 42299919 · 2026-06-16

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学術誌BJU international

年2026-06-16

PMID42299919

抄録

To systematically characterise United States Food and Drug Administration (FDA) authorised urology-specific artificial intelligence (AI)-enabled medical devices and to evaluate the publicly available evidence supporting their authorisation. We reviewed the FDA AI-Enabled Medical Devices List. Devices cleared by September 2025 were manually screened for urological relevance using FDA clearance documents (e.g., 510(k), De Novo) to confirm clinical application. Eligible devices were categorised by

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