Artificial intelligence in urology: A review of United States Food and Drug Administration-cleared devices.

Abstract

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