PubMed

우로로지에서 인공지능: 미국 식품의약국(FDA) 승인된 장비 리뷰

PMID: 42299919 · 2026-06-16

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학술지BJU international

연도2026-06-16

PMID42299919

초록

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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