PubMed

泌尿科中的人工智能：美国食品药品监督管理局（FDA）批准的设备的综述。

PMID：42299919 · 2026-06-16

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期刊BJU international

年份2026-06-16

PMID42299919

摘要

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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