UroViu said yesterday it won FDA 510(k) clearance for its Uro-V single-use diagnostic cytoscopic system designed to visually assess the urethra and urinary bladder in instances of suspected pathology or dysfunction.
The Bellevue, Wash.-based company’s newly cleared Uro-V device is a self-contained single-use diagnostic cytoscope designed for female diagnostic cytoscopy. The system is designed to be light-weight, portable and battery powered with a disposable cannula and a reusable handle, video processor, LCD display and touchscreen display.
“Today’s growing and aging population faces a severe problem of an increasing shortage of urologists. The Uro-V Cystoscope has great potential to make the standard urological care more accessible and convenient for the patients while greatly reducing the burden of the urologists and staff,” Dr. Marshall Stoller of the University of California San Francisco said in prepared remarks.
UroViu said it has completed a prospective, observational open-label usability study of 64 subjects who were candidates for office diagnostic cytoscopy at 2 centers in the US and Europe. Results from the study were completed without incident or adverse reactions, the company said.
“Our group of 12 providers made the decision to change to disposable sheaths after critical review of single-use versus reusable scopes, finding significant advantages clinically and economically: safer for patient, ease of use for staff, decreased preparation time, overall decreased cost to provider, with higher safety margin—faster turnover of procedure room, equipment, improved patient time efficiency, increased revenue—lower overall cost, increased number of cystoscopy procedures per day and I think that Uro-V will further improve the single-use model—better visualization digital vs analog, less risk of scope malfunction, improved prep time even compared to single-use sheath (which still requires cleansing scope prior to overlaying scope), ability to show in real time to patient operative findings,” trial principal investigator Dr. Vijay Goli of the University of Nevada School of Medicine said in a prepared release.
“The device was easy to use; my staff preferred it due to easy set up and off-the-shelf availability, and patients were satisfied due to less discomfort than they experienced with standard scopes,” trial principal investigator Dr. Jed Kaminetsky of Manhattan Medical Research said in a press release.
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