Disposable Colonoscope Gets OK From FDA

An Israeli medical technology company has won approval from the U.S. Food and Drug Administration (FDA) for a colonoscope that could facilitate early detection of cancer, Globes reported.

The developer, GI View, describes the new instrument, called Aer-O-Scope, as an easy-to-use, omni-directional, disposable system that can use snares and forceps to take biopsies or perform polypectomies.

GI View CEO Tal Simchony said that the 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. We are now working on U.S. market introduction of the Aer-O-Scope. Post market studies are also in the plans.”

The Aer-O-Scope is the first colonoscope to provide a 360° omni-directional visualization of the colon to detect polyps behind folds.

Its disposability eliminates risk of contamination or disease transmission between patients. Other features are designed for safety and patient comfort, such as the hydrophilic tube, which reduces operational friction by more than 90 percent.

The joystick control makes it simple to operate and requires minimal training. Like all colonoscopes, the Aer-O-Scope provides insufflation, irrigation and suction.