GI View Receives 510(K) FDA Clearance for the Aer-O-Scope™ Colonoscope System for Colorectal Cancer Screening. Aer-O-Scope™ is the only single use, self propelled colonoscope with full 360° Omni-directional View of the colon

Ramat Gan, Israel, December 2, 2014, GI View, developer of advanced GI screening systems, announced today that it has received FDA 510(k) clearance for its flagship product, the Aer-O-Scope™, the most advanced and comprehensive system for colorectal cancer screening. Market introduction is expected in the U.S. in early 2016

“Clinical results confirm that Aer-O-Scope™ offers reliable, safe and cost-effective colorectal cancer screening. Finally A disposable colonoscope that has the potential to increase adenoma detection rate” said Prof. Zamir Halpern, Director of the Digestive Tract Center, Tel Aviv Sourasky Medical Center, principal investigator of several of the Aer-O-Scope™ clinical studies.

There are several issues with today’s colonoscope technologies. As they are not disposable, and could pose a risk of disease transmission. As they are manual, they require prolonged training of the doctor, and outcomes are very skill dependant. And, as their cameras have a limited field of view, they do not provide a complete picture of the colon especially behind colonic folds. Aer-O-Scope™ has overcome all of these drawbacks.

Dr. Tal Simchony, CEO of GI-View said, “Aer-O-Scope™ is the only colorectal screening product that is single use, self propelled and has 360° omni-directional visualization, meaning the physician can see every inch of the colon, including behind folds. This is key to making sure that if a polyp or lesion it there, it could be found.”

Aer-O-Scope™ is made from a soft multi-lumen tube that puts very little pressure on the colon wall. This should increase patient safety and comfort. Aer-O-Scope™ uses balloons and low pressure CO2 gas for self-propelled intubation maximizing safety and ease-of-use. It is also joystick controlled, rendering training minimal and the system extremely simple for GI clinics and hospital outpatient departments to operate. And, as Aer-O-Scope™ is a single use, disposable colonoscope, there is also no risk of disease transmission. Like all colonoscopes, it provides insufflation, irrigation and suction