FDA gives 510(k) approval to Aer-O-Scope Colonoscopy Imaging System-GI Imaging

GI View has announced it has received FDA 510(k) clearance for its Aer-O-Scope Colonoscope System, an advanced, comprehensive and easy-to-use Imaging System for Colorectal Cancer screening. Market introduction is expected in the US in early 2016. The device already has CE mark approval in Europe.

Aer-O-Scope is the only colorectal screening product that is single use, self-propelled and has 360� omni-directional visualization. Its soft multi-lumen tube is designed to significantly reduce pressure on the colon wall, which in turn, increases patient safety. As the system is joystick controlled it is also extremely simple to operate and requires minimal training.