{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T08:30:11Z","timestamp":1786437011930,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To systematically characterise United States Food and Drug Administration (FDA) authorised urology\u2010specific artificial intelligence (AI)\u2010enabled medical devices and to evaluate the publicly available evidence supporting their authorisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We reviewed the FDA AI\u2013Enabled 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 FDA approval pathway, review panel, indication, and year of approval. FDA decision summaries were reviewed to characterise study design, training\/testing and external validation features, and reporting of patient demographics. Descriptive statistics were used to summarise distributions and temporal trends.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 1358 FDA\u2010cleared AI devices, 30 (2.2%) were urology specific. Approvals increased over time, with 26.7% cleared in 2025 (through September). The predominant FDA medical device category was Radiology (70.0%), with indications led by prostate imaging (43.3%). Information on study design, recruitment, and validation was frequently unavailable. Race and ethnicity were reported in one device (3.3%) for training\/testing and four devices (13.3%) for external validation. Among these, aggregated proportions showed that the majority of subjects were White (86.1% for training\/testing; 87.6% for external validation).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The FDA\u2010authorised urological AI devices are dominated by radiology\u2010based, prostate\u2010focused applications and have increased in recent years. However, publicly available evidence supporting their authorisation is often limited, with incomplete reporting of study design and patient demographics. Greater transparency and post\u2010authorisation evaluation are needed to support interpretation of these tools in clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.70345","type":"journal-article","created":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T11:15:19Z","timestamp":1781608519000},"page":"424-429","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Artificial intelligence in urology: A review of\n                    <scp>United States<\/scp>\n                    Food and Drug Administration\u2010cleared devices"],"prefix":"10.1111","volume":"138","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9953-3074","authenticated-orcid":false,"given":"Zhiyu","family":"Qian","sequence":"first","affiliation":[{"name":"Brigham and Women's Hospital Harvard Medical School  Boston MA USA"},{"name":"Center for Surgery and Public Health Brigham and Women's Hospital, Harvard Medical School  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pietro","family":"Brin","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital Harvard Medical School  Boston MA USA"},{"name":"Center for Surgery and Public Health Brigham and Women's Hospital, Harvard Medical School  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Korn","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital Harvard Medical School  Boston MA USA"},{"name":"Center for Surgery and Public Health Brigham and Women's Hospital, Harvard Medical School  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-5987-4659","authenticated-orcid":false,"given":"Andrea","family":"Cosenza","sequence":"additional","affiliation":[{"name":"Department of Urology University of Pittsburgh Medical Center  Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna","family":"Zurl","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital Harvard Medical School  Boston MA USA"},{"name":"Center for Surgery and Public Health Brigham and Women's Hospital, Harvard Medical School  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klara","family":"Pohl","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital Harvard Medical School  Boston MA USA"},{"name":"Center for Surgery and Public Health Brigham and Women's Hospital, Harvard Medical School  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jina","family":"Pakpoor","sequence":"additional","affiliation":[{"name":"Department of Radiology University College London Hospitals Trust  London UK"},{"name":"Division of Surgical and Interventional Science University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline M.","family":"Moore","sequence":"additional","affiliation":[{"name":"Division of Surgical and Interventional Science University College London  London UK"},{"name":"Department of Urology University College London Hospitals Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Giganti","sequence":"additional","affiliation":[{"name":"Department of Radiology University College London Hospitals Trust  London UK"},{"name":"Division of Surgical and Interventional Science University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quoc\u2010Dien","family":"Trinh","sequence":"additional","affiliation":[{"name":"Department of Urology University of Pittsburgh Medical Center  Pittsburgh PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0049-8529","authenticated-orcid":false,"given":"Alexander P.","family":"Cole","sequence":"additional","affiliation":[{"name":"Division of Urology Maine Health Pen Bay Hospital  Rockport ME USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,16]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra2302038"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-019-03000-5"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ucl.2023.06.005"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2017.07.068"},{"key":"e_1_2_10_6_1","first-page":"72","article-title":"Claims\u2010based analysis of national utilization patterns and regional variability of prostate cancer ablative therapies: a medicare study","volume":"40","author":"Korn SM","year":"2026","journal-title":"J Endourol"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40644-025-00898-6"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-025-02052-9"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2025.3351"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2024.21451"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41585-025-01081-z"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41585-019-0193-3"},{"key":"e_1_2_10_13_1","article-title":"Geographic variability in germline genetic testing for prostate cancer: a Nationwide Medicare claims study with evidence of low uptake","volume":"23","author":"Korn SM","year":"2025","journal-title":"J Natl Compr Cancer Netw"},{"key":"e_1_2_10_14_1","article-title":"Prostate magnetic resonance imaging utilization and its relationship with advanced prostate cancer detection","volume":"42","author":"Qian Z","year":"2024","journal-title":"Urol Oncol Semin Orig Investig"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.42338"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01595-0"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra2214964"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2024.111606"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-022-11012-2"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacr.2023.06.025"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.12779"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.8052"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00330-021-07892-z"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00330-025-11830-8"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/jncics\/pkae016"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-025-04448-6"},{"key":"e_1_2_10_27_1","unstructured":"Dicennial Census.US Census Bureau US Census Bureau.2020"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2025.5183"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2025.1016"}],"container-title":["BJU International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.70345","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bju.70345","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.70345","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T08:01:18Z","timestamp":1786435278000},"score":1,"resource":{"primary":{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/10.1111\/bju.70345"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,16]]},"references-count":28,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1111\/bju.70345"],"URL":"https:\/\/doi.org\/10.1111\/bju.70345","archive":["Portico"],"relation":{},"ISSN":["1464-4096","1464-410X"],"issn-type":[{"value":"1464-4096","type":"print"},{"value":"1464-410X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,16]]},"assertion":[{"value":"2026-06-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}