FDAnews
www.fdanews.com/articles/168893-gi-views-colonoscope-with-360-degree-view-gets-fda-ok

GI View’s Colonoscope With 360-Degree View Gets FDA OK

December 4, 2014

Israeli devicemaker GI View says it will launch its Aer-O-Scope colonoscope system in the U.S. market in early 2016, following the receipt of FDA 510(k) clearance. The device is the only colonoscope with a 360-degree omnidirectional view for colon cancer screening.

According to CEO Tal Simchony, the easy-to-use, disposable, single-use Aer-O-Scope’s 360-degree visualization allows physicians to observe the entire lining of the colon, including behind folds, which is critical for a complete colonic assessment. If there is a polyp in the colon, the Aer-O-Scope will give the physician the best chance of finding it, he says.

Another advantage of the Aer-O-Scope, the company says, is its soft multilumen tube, which reduces pressure on the colon wall, increasing patient safety. Insertion of the tube is self-propelled using balloons and low-pressure carbon dioxide gas and controlled by a joystick, making it easy to operate with little training, GI View adds.

Like other colonoscopes, Aer-O-Scope also provides insufflation, irrigation and suction, the devicemaker notes.

Colorectal cancer is the second leading cause of cancer deaths in the western world, according to GI View, with over 500,000 occurring annually. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.