Disposable colonoscope receives FDA 501(k) clearance

GI View Ltd. have received FDA 501(k) clearance for their Aer-O-Scope Colonoscope System, which is disposable and self-propelled with a joystick control.

As the first scope to offer 360° omni-directional visualization, the Aer-O-Scope is able to show difficult to spot polyps that are hidden behind folds. This advanced visualization gives physicians and patients a step up on the early detection of colon cancer.

The device is meant to be used only once, meaning there is no risk of contamination between patients. The scope uses a hydrophilic multi-lumen tube, reducing friction by 90 percent. Using balloon and low pressure carbon gas, the system is equipped with self-propelled intubation to improve patient safety and comfort. The device is controlled by a joystick, making it easy to train and simple to use.

"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, effectively and efficiently identify and remove polyps and prevent colon cancer," said GI-View CEO Tal Simchony, PhD. "We are now working on US market introduction of the Aer-O-Scope. Post market studies are also in the plans."