UroViu wins FDA Clearance for new cordless endoscope platform

UroViu wins FDA Clearance for endoscope platform: ©UroViu

UroViu Corp. announced it has received clearance from the U.S. Food and Drug Administration for its latest endoscopic device, the UV5000 cordless, single-use endoscope platform.

The UV5000, which replaces the company’s UV4500, features a faster processor, longer battery life, and brighter high-definition visualization within the clinician’s line of sight. It is compatible with UroViu’s portfolio of disposable endoscope cannulas, graspers, and biopsy forceps.

UroViu has also filed a 510(k) application for a Wi-Fi–enabled model, the UV5000W, which would allow wireless connection to external displays.

Bruce OuYang, Ph.D., CEO of UroViu, said the company designed the UV5000 to provide benefits for both patients and providers, with an emphasis on reducing environmental impact, expanding procedural flexibility, and supporting a wide range of clinical needs.

“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,” OuYang said in a statement.

The cordless, untethered design reduces the amount of material required compared to traditional devices, according to the company. Its compact size and portability enable procedures to be conducted in a broader range of clinical settings, effectively turning any room into a procedure room. The UV5000 also supports the rapid integration of new single-use cannulas tailored to different medical applications.

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

UroViu, based in Los Altos, California, develops, manufactures, and markets single-use endoscopic visualization solutions worldwide.

Advances in single-use endoscopy technology

The FDA clearance of UroViu’s UV5000 comes amid broader momentum in the single-use endoscopy sector, as clinicians and manufacturers push for solutions that balance patient safety, operational efficiency, and sustainability.

One of the major trends shaping this field is the shift away from reusable endoscopes, which require time-consuming reprocessing between patients and can be associated with risks of cross-contamination. Single-use platforms eliminate those challenges by providing a sterile device for each procedure. This can be particularly valuable in ambulatory surgery centers and outpatient clinics, where efficiency and infection control are critical.

In addition to sterility, improvements in imaging quality have been a central focus. Many of the latest systems incorporate enhanced HD or even 4K visualization, providing clinicians with sharper images that can improve diagnostic accuracy and procedural confidence. Brighter optics and more responsive processors have also helped streamline workflows during minimally invasive procedures.

Portability has emerged as another differentiator. Compact, cordless devices are allowing providers to perform procedures outside of traditional operating rooms, which not only expands scheduling capacity but also lowers costs for facilities and patients. This flexibility has been seen as an important step toward democratizing access to advanced care in both urban and rural settings.

Manufacturers are also working to address environmental concerns associated with single-use devices. New designs aim to minimize material use, reduce packaging waste, and explore recycling pathways where feasible. Battery efficiency and lightweight construction are increasingly important factors in balancing convenience with sustainability.

Finally, connectivity is becoming a key feature of next-generation platforms. Wireless integration with external monitors, electronic health records, and even cloud-based data platforms is enabling more seamless clinical documentation and telemedicine applications. This aligns with broader digital health initiatives, where real-time data sharing and interoperability are becoming essential.