Zsquare, a developer of high-performance, single-use endoscopes, received U.S. FDA 510(K) clearance to market its first product, the Zsquare ENT-Flex Rhinolaryngoscope, a single-use endoscope.

Zsquare plans a pilot launch in U.S. hospitals and physician practice offices by Q4 2022.

The Zsquare ENT-Flex Rhinolaryngoscope is indicated for use in diagnostic ENT procedures by way of the nose and throat and is the only scalable platform capable of transmitting high-resolution images in flexible, single-use endoscopes. Zsquare ENT-Flex is the first single-use endoscope using a hybrid design in which its all-optical disposable shell fully covers a reusable imaging core.

The device’s engineering has several benefits, including improved patient comfort and enhanced diagnostic quality. The size and image quality of this first-to-market Zsquare product offer greater accessibility in endoscopic procedures.

“As the world continues to confront cross contamination risks, Zsquare has collaborated closely with clinicians and regulatory authorities to pioneer innovative technologies with groundbreaking patient-care capabilities to advance the endoscopy industry’s shift to single-use devices,” says Asaf Shahmoon, CEO and co-founder of Zsquare. “This is a significant milestone and delivers on our pledge to transform the endoscopy market, setting a new standard for single-use endoscopes.”

The company’s patented polymeric imaging fiber features flexible, ultra-thin properties that enable smaller than ever endoscopes that can access formerly unreachable anatomical sites without compromising image quality. The hybrid endoscope design enables rapid cross-industry scalability by allowing the same imaging core to be used with different indication-specific disposable shells that are purpose-made for ENT, urology, bronchoscopy, GI, gynecology, and more.

“We are very excited for this major achievement,”says Eyal Agmoni, chairman of Chartered Group, Zsquare’s leading investor. “As we continue to support Zsquare’s rapid growth, this milestone enables it to ramp up activity and establish mass manufacturing capabilities to achieve the production of millions of units per year, on its way to take over the single-use endoscopy market.”

The company believes that this initial regulatory achievement is a steppingstone for Zsquare as the approval of its reusable components supports accelerated clearance of single-use shells for other clinical fields such as cystoscopy, bronchoscopy, gastroenterology, and more.

“The Zsquare ENT-Flex Rhinolaryngoscope is the first single-use endoscope to show superior capabilities than reusable scopes with the same diameter – from superior image quality to a smaller outer diameter,” says Professor Hisao Tajiri, MD, senior advisor, Japan Gastroenterological Endoscopy Society (JGES) and member of the Zsquare Scientific Advisory Board. “This groundbreaking FDA approval to market opens the door to an industry shift toward affordable, high-performance hybrid single-use endoscopes in other indications of use.”

Featured image: Zsquare ENT-Flex Rhinolaryngoscope single-use endoscope. Photo: Zsquare