Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023.

Abstract

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. Our objective was to characterize trends in US Food and Drug Administration device approvals in urology from 1990 to 2023 and assess regulatory, market, and subspecialty factors associated with device development activity. US Food and Drug Administration data