Israel-based GI View has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new Aer-O-Scope colonoscope system.
Aer-O-Scope is a disposable, self-propelled, joystick-controlled and easy-to-use colonoscope system with therapeutic access.
The new system features two working channels, which allow therapeutic access using standard tools such as snares and forceps to take biopsies or perform polypectomies.
Aer-O-Scope offers 360° omni-directional visualization of the colon to detect polyps behind folds.
It deploys a soft multi-lumen tube that will reduce pressure on the colon wall. The tube is also hydrophilic, that helps to reduce the friction between bowel and scope by around 90%.
The system’s self-propelled intubation, which is created by using balloons and low pressure CO2 gas, enables to maximize the physician ease of use and ensures the patient safety and comfort.
According to the company, the new Aer-O-Scope provides insufflation, irrigation and suction similar to all colonoscopes.
GI View CEO Tal Simchony said: “The new Aer-O-Scope system with therapeutic access has many significant clinical benefits including enabling physicians to more easily, effectively and efficiently identify and remove polyps and prevent colon cancer.
"We are now working on US market introduction of the Aer-O-Scope. Post market studies are also in the plans."
Israel HealthCare Ventures, Ziegler Meditech Equity Partners and Kemper Insurance are some of the investor in the GI-View, which has around 55 granted patents and dozens more pending.