Israeli developer of advanced GI screening systems, GI View Ltd., has announced that it has received U.S. FDA 510(k) clearance for its flagship product, the Aer-O-Scope™ Colonoscope System, an advanced, comprehensive and easy-to-use system for colorectal cancer screening. Market introduction is expected in the U.S. in early 2016.
Background
A few weeks ago we covered the news that digital imaging device specialist Avantis Medical Systems had gained U.S. FDA 510(k) clearance of its of Third Eye® Panoramic™ Device for Colonoscopy. Now it seems there’s another entrant to the panoramic colonoscopy market, in the form of GI View, with its Aer-O-Scope system.
The Aer-O-Scope™ system provides 360° omni-directional visualization and claims several other unique advantages including a soft multi-lumen tube, designed to significantly reduce pressure on the colon wall. Safety and ease of use are further maximized by the system’s self-propelled intubation, created using balloons and low pressure CO2 gas. As the system is joystick controlled it is also extremely simple to operate and requires minimal training. The colonoscope is single use and disposable, so there is no risk of disease transmission from it.
Like other colonoscopes, Aer-O-Scope™ also provides insufflation, irrigation and suction.
Investigator comments
“Aer-O-Scope™ provides reliable and safe colorectal cancer screening. It also has the potential to increase the adenoma detection rate and concurrently help to prevent cancer,” said Erwin Santo MD, Head, Department of Gastroenterology and Liver Diseases, Tel Aviv Sourasky Medical Center and principal investigator of the most recent Aer-O-Scope™ clinical trial.
Company comments
Dr. Tal Simchony, CEO of GI-View Ltd. said, “Aer-O-Scope™ is the only colorectal screening product that is single use, self-propelled and has 360° omni-directional visualization. This enables the physician to observe all the mucosa of the colon, including behind folds, which is critical for a complete colonic assessment. If a polyp is there, Aer-O-Scope™ will allow the physician the best possible chance of finding it.”
Source: GI View Ltd., PR Newswire
published: December 3, 2014 in: Approval/Clearance, Gastroenterology, Imaging