PubMed

泌尿科的人工智能：美國食品藥品管理局批准設備的評論。

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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