Urology has historically led surgical innovation with the early adoption of endoscopy, minimally invasive surgery, and neurostimulation devices. However, the current trajectory of innovation across urologic subspecialties remains undefined.
To characterize trends in U.S. Food and Drug Administration (FDA) device approvals in urology from 1990 to 2023 and assess regulatory, market, and subspecialty factors associated with device development activity.
FDA databases were queried for all devices approved through the Gastroenterology-Urology Device Panel between 1990 and 2023. Devices were categorized by subspecialty, regulatory pathway, device class, and company experience. Descriptive statistics and comparative analyses assessed approval trends, processing times, and market entry dynamics.
Of 7,860 devices approved by the Gastroenterology-Urology Panel, 4,300 (54.7%) were urologic. Device approvals peaked in 1994 and then declined 76% between 1994 to 2023. Endourology accounted for 50.6% of devices, but experienced a 60.7% decline in growth. Urogynecology and reconstructive pelvic surgery (URPS) and neurourology demonstrated significant growth (833.3% and 650.0%, respectively), albeit from a low baseline. Most devices were Class II (94.0%) and approved via the 510(k) pathway (98.7%). Approval times varied by device class (p < 0.001) and were shorter for companies with prior regulatory experience (p < 0.001).
Urologic device regulatory approvals have declined since the 1990s in traditionally dominant subspecialties. While growth is emerging in underrepresented areas such as URPS and neurourology, prolonged approval timelines within these subspecialties may impede progress. Regulatory reform and industry support may help revitalize innovation in urologic technology.
Urology practice. 2026 Mar 26 [Epub ahead of print]
Sam Duggan, Antony Fuleihan, Arjun K Menta, Marco Goldberg, Costas Lallas, Mihir Shah, Patrick Shenot, Adam Metwalli, Scott Hubosky, Patrick Gomella, Whitney Smith, Masaya Jimbo, Paul Chung, Paul Bloch, Leonard Gomella
Department of Urology, Thomas Jefferson University Hospital, Philadelphia, PA., Johns Hopkins University School of Medicine, Baltimore, MD.