GI View’s Aer-O-Scope Colonoscope System gets FDA 510(k) clearance

3 December 2014 (Last Updated December 3rd, 2014 18:30)

Israel-based GI View has received US Food and Drug Administration (FDA) 510(k) clearance for the Aer-O-Scope Colonoscope System.

Israel-based GI View has received US Food and Drug Administration (FDA) 510(k) clearance for the Aer-O-Scope Colonoscope System.

It is an advanced, comprehensive and easy-to-use system for colorectal cancer screening.

GI View expects to introduce the new Aer-O-Scope Colonoscope System in the US in early 2016.

Colorectal cancer is the second biggest cause of cancer death in most western countries and can always be prevented by early detection and removal of polyps.

Tel Aviv Sourasky Medical Center head of Gastroenterology and Liver Diseases Erwin Santo said: "Aer-O-Scope provides reliable and safe colorectal cancer screening.

"Aer-O-Scope features a soft multi-lumen tube, designed to significantly reduce pressure on the colon wall and increase patient safety."

"It also has the potential to increase the adenoma detection rate and concurrently help to prevent cancer."

Aer-O-Scope features a soft multi-lumen tube, designed to significantly reduce pressure on the colon wall and increase patient safety.

The company said safety and ease of use are maximised by the system's self-propelled intubation, created using balloons and low-pressure CO2 gas.

GI View CEO Dr Tal Simchony said: "Aer-O-Scope is the only colorectal screening product that is single use, self-propelled and has 360° omni-directional visualisation.

"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."