Smart Medical Systems announced today that it received an additional FDA clearance for its G-Eye colonoscope. G-Eye, which is based on Fujifilm’s FDA-cleared colonoscopes, has FDA 510(k) clearance and is remanufactured by Smart to include a proprietary balloon at its distal bending section. The portfolio of colonoscopes includes selected models of endoscope brands including Fujifilm, […]
Smart Medical Systems yesterday said it received FDA 510(k) clearance for its G-Eye Colonoscope. The device is a standard colonoscope that installs the company’s G-Eye balloon on the distal bending section of the colonoscope. The G-Eye is then inserted using the standard technique with an inflated balloon. The balloon is inflated to engage the colon […]
Under the terms of a new agreement Pentax Medical plans to commercialize its G-Eye endoscope in Europe, the Middle-East and Africa.
The endoscope utilizes Smart’s G-Eye balloon and the HD+ PENTAX Medical colonoscope in order to “centralize the image in the colon lumen and flattens colon folds, thereby providing enhanced visualization of the colon and enabling an increase in polyp detection,” according to a press release.