Intended for use in diagnostic ENT operations through the nose and throat, the Zsquare ENT-Flex Rhinolaryngoscope is said to be the only scalable platform capable of transmitting high-resolution pictures in flexible, single-use endoscopes
Zsquare ENT-Flex Single-Use Rhinolaryngoscope. (Credit: PRNewswire/ Zsquare)
Israel-based Zsquare has received the US Food and Drug Administration (FDA) 510K clearance to commercialise its Zsquare ENT-Flex Rhinolaryngoscope.
Intended for use in diagnostic ENT operations through the nose and throat, the Zsquare ENT-Flex Rhinolaryngoscope is said to be the only scalable platform capable of transmitting high-resolution pictures in flexible, single-use endoscopes.
Zsquare said that it is the first single-use endoscope with a hybrid design, which completely encases a reusable imaging core in an all-optical disposable shell.
Through the smallest diameter endoscope shaft, the improved design offers healthcare providers high-quality imaging at the lowest cost-per-use in single-use endoscopy.
The new product offers benefits such as increased patient comfort, better diagnostic accuracy, more cost savings and enhanced accessibility during endoscopic treatments due to its size and picture quality.
Zsquare CEO and co-founder Asaf Shahmoon said: “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.
“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 said that its patent polymeric imaging fibre is a landmark development in the field of miniaturising visual fibre-optics.
It has flexible, ultra-thin characteristics for smaller than ever endoscopes which can provide access to previously inaccessible anatomical regions without sacrificing picture quality.
The hybrid endoscope design enables quick cross-industry scaling by enabling the similar imaging core to be leveraged with several indication-specific disposable shells that are specifically built for ENT, urology, bronchoscopy, GI, and gynaecology.
The company is planning to conduct a test launch at major hospitals and physician practice offices in the US by the fourth quarter of this year.