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.
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