Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, July 06 2022 - 10:00
Zsquare receives FDA Clearance to Market for First High-Performance Single-Use ENT Endoscope
TEL AVIV, Israel, July 6, 2022 /PRNewswire-AsiaNet/ --

- Company's patented polymeric fiber is a breakthrough in the world of 
miniaturizing visualization

- Zsquare ENT-Flex(TM) Rhinolaryngoscope advances the ENT category with a 
best-in-class 2.3mm outer diameter for high-resolution image quality at the 
lowest cost for the single-use market

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(TM) Rhinolaryngoscope. Zsquare 
plans a pilot launch in leading United States hospitals and physician practice 
offices by Q4 2022.

The Zsquare ENT-Flex(TM) 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(TM) 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 

"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(TM) 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."

About Zsquare:
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. 

For more information:  

Follow Zsquare on LinkedIn [ ] |Twitter [ ]

Company Contact:
Chen Goldstein

Photo -
Logo -

Source: Zsquare