Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990-2023.
Publication/Presentation Date
3-26-2026
Abstract
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
First Page
101097
Last Page
101097
ISSN
2352-0787
Published In/Presented At
Duggan, S., Fuleihan, A., Menta, A. K., Goldberg, M., Lallas, C., Shah, M., Shenot, P., Metwalli, A., Hubosky, S., Gomella, P., Smith, W., Jimbo, M., Chung, P., Bloch, P., & Gomella, L. (2026). Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990-2023. Urology practice, 101097UPJ0000000000001002. Advance online publication. https://doi.org/10.1097/UPJ.0000000000001002
Disciplines
Education | Medical Education | Medicine and Health Sciences
PubMedID
41886403
Department(s)
Department of Education
Document Type
Article