Israel-based GI View has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Aer-O-Scope Colonoscope System.
The system is a disposable, self-propelled, joystick-controlled device featuring two working channels which enable the usage of standard tools, such as snares and forceps for biopsies or polypectomies.
It offers a 360° omni-directional visualisation of the colon to detect polyps behind folds.
The colonoscope system constituts of two main components, the Aer-O-Scope Disposable Scanner (colonoscope component) and the Aer-O-Scope PC-Based Work Station.
The colonoscope component uses a soft multi-lumen tube designed to reduce pressure on the colon wall, ensuring patient safety. Its pneumatic self-propulsion mechanism uses balloons and low pressure CO2 gas to induce self-propelled intubation.
The Aer-O-Scope work station offers all the necessary elements to operate the disposable scanner which are CO2, water, suction and air pressure, as well as the power supply for the camera and illumination.
It also receives and processes data received from the camera and scanner, including pneumatic controls and pressure measurements used by the control software to manage advancement within the colon.
The work station is also fitted with a physician device interface and its ergonomic joystick enables intuitive control of navigation, insufflation, irrigation, and suction.
GI-View CEO Tal Simchony said: “Today’s news marks the achievement of an important regulatory milestone.
“The new Aer-O-Scope system with therapeutic access has many significant clinical benefits including enabling physicians to more easily and efficiently identify and remove polyps and prevent colon cancer.”