GI-View wins FDA clearance for Aer-O-Scope disposable colonoscope

GI-View said today that its Aer-O-Scope colonoscopy device won 510(k) clearance from the FDA.

The company’s flagship product is a disposable colonoscope with 2 channels for tools to take biopsies during a colon cancer screening. The device is the 1st colonoscope to provide a 360-degree view of the colon to detect polyps behind folds, according to Israel-based GI-View.

The colonoscope uses a soft multi-lumen tube developed to reduce pressure on the colon wall. There’s no risk of contamination between patients because the device is disposable. The company reports that its hydrophilic tube reduces friction between the bowel and scope by more than 90%.

The system is controlled using a joy-stick and self-propelled with balloons and low pressure carbon dioxide gas.

Colorectal cancer is the second leading cause of cancer-related deaths in men and women in the U.S., according to the American Cancer Society. But the death rate has dropped over several decades, the society reported, due in part to doctors screening patients more regularly and advancements in screening techniques.

“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,” GI-View CEO Tal Simchony said in prepared remarks. “We are now working on US market introduction of the Aer-O-Scope. Post market studies are also in the plans.”

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