Zsquare receives FDA clearance to market for first high-performance single-use ENT endoscope
July 06, 2022
TEL AVIV, Israel, July 6, 2022 /PRNewswire/ -- Zsquare, a leading developer of high-performance, single-use endoscopes, announces that it received Food and Drug Administration 510K clearance to market its first product, the Zsquare ENT-Flex™ Rhinolaryngoscope. Zsquare plans a pilot launch in leading United States 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 enhanced design provides health professionals with high resolution imaging at the lowest cost-per-use in single-use endoscopy, through the smallest diameter endoscope shaft. This unique engineering has several benefits, including improved patient comfort, enhanced diagnostic quality and significant savings for providers and payers. 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." Said 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," he added.
The company's patented polymeric imaging fiber is a breakthrough in the world of miniaturizing visual fiber-optics. Its flexible, ultra-thin properties 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.", Said 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," said Professor Hisao Tajiri, M.D., 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."
Zsquare, a privately held medical device company, has developed the only scalable platform capable of transmitting high-resolution images in flexible, single-use endoscopes. The two-part endoscope design allows the same imaging core to be used while switching indication-specific shells that are purpose-made for ENT, bronchoscopy, duodenoscopy, urology, gynecology, and more. The cost-effective, high-performance endoscopes enable access to unserved indications, improve performance in current practices, and solve the industry's cross-contamination challenge. Advancing endoscopic diagnostic technologies, Zsquare is democratizing patient care and optimizing patient outcomes and hospital efficiency one single-use endoscope at a time.