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, Olympus and Pentax, according to a news release.
Ra’anana, Israel-based Smart said the withdrawal of G-Eye with the balloon moderately inflated during a colonoscopy aids in controlling a colonoscope’s field of view and positioning.
The G-Eye has been installed in the U.S., with the first one taking place at NYU Langone Health in collaboration with Fujifilm, followed by continued use in the NYU Langone endoscopy unit.
“We are committed to our mission of making the G-Eye a standard of care in colonoscopy,” Smart CEO Gadi Terliuc said in the release. “Solid clinical data and close interaction with the clinical community will pave the way for broad acceptance of the G-Eye technology in daily routine.”