510(k) clearance to G-EYE colonoscope

June 10, 2020 0 By FM

SMART Medical Systems Ltd announced that the US FDA issued 510(k) clearance for its G-EYE colonoscope.

The G-EYE colonoscope is a standard colonoscope which SMART remanufactures by installing its proprietary G-EYE balloon on the distal bending section of the colonoscope.

During colonoscopy, the G-EYE colonoscope is inserted using the standard technique, with the balloon deflated. Once the colon is intubated and prior to withdrawal, the balloon is inflated to engage the colon lumen. 

Withdrawal of the G-EYE Colonoscope through the colon with the balloon moderately inflated centralises the image of the colon lumen, flattens colonic folds, and reduces the amount of bowel slippage, thereby assisting in controlling the colonoscope’s field of view and positioning. 

In published clinical studies comparing adenoma detection rate of G-EYE colonoscopy to that of standard colonoscopy, G-EYE colonoscopy demonstrated substantial increase in the detection of cancerous polyps which are the precursors of colon cancer.