FDA Clears UroViu’s UV5000 Advanced Endoscope Platform

UroViu Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UV5000 cordless, single-use endoscope platform.

The UV5000 replaces the UV4500 on the market, offering a faster processor, longer battery life, and brighter HD visualization directly within the clinician’s line of sight. It is compatible with all of UroViu’s single-use endoscope cannulas, graspers, and biopsy forceps. As a companion to the UV5000, UroViu has submitted a 510(k) application for a model, the UV5000W, that has built-in WiFi connectivity to external displays.

“UroViu strives to achieve a win-win situation for patients and care providers and has gained adoption across all segments of the market, including private practices, ASCs, academic institutions, VA, and DOD healthcare facilities, benefiting from the following unique features,” UroViu CEO Bruce OuYang, Ph.D., said:

• Cordless, untethered design: This minimizes the environmental impact and carbon footprint of disposable products by eliminating any cords. The profile and weight of all UroViu disposables are half or a third compared to similar products on the market, according to the company.
• Portability and Simplicity: The UV5000 turns any room into a procedure room, allowing for schedule expansion and creating efficiency.
• Versatile platform: The UV5000 platform allows for fast additions of new single-use cannulas optimized for various indications, aiming to provide a complete set of tools for users without investing in additional reusable devices.”

The UV5000 is now available in the U.S. market.

Based in Los Altos, Calif., UroVie’develops, manufactures, and commercializes advanced single-use endoscopic visualization solutions worldwide. The company pioneered the world’s most portable cystoscopy platform that is always ready, eliminating the need for reprocessing, capital equipment, servicing, and advance scheduling. UroViu’s mission is to simplify workflows and expand access to high-quality endoscopy by integrating cutting-edge technologies, including edge AI and robotics.