FDA approves Uro-V single-use diagnostic cystoscopic system .- UroViu Corporation .

UroViu Corporation has announced that its Uro-V single-use diagnostic cystoscopic system has received 510(k) clearance from the FDA. Additionally, the United States Patent and Trademark Office has issued a patent to UroViu on the Uro-V System. The single-use disposable, semi-flexible, easy-to-use and patient-friendly Uro-V System represents a major advance in diagnostic cystoscopy. The semi-flexible disposable device is intended for assessing the urethra and urinary bladder in women while reducing the chances of infection and increasing patient comfort.

Uro-V is a self-contained, off-the-shelf, single-use diagnostic cystoscope specifically designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. Uro-V is a light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that includes video processor, LCD display, and touch panel user interface. The cannula is hydrophilic coated with an outer diameter of 12 Fr. and has a 140-degree field-of-view camera, with 30-degree deflection and LED illumination module at its tip and a shared single channel for fluid infusion.