Smart Medical Systems this week announced that it received additional FDA clearance for its G-Eye Colonoscope.
The G-Eye Colonoscope includes a balloon at the distal bending section that moderately inflates during colonoscopies to assist in controlling the colonoscope’s field of view and positioning.
In published clinical studies, G-Eye colonoscopy demonstrated substantial increase over standard colonoscopy in the detection of pre-cancerous polyps, which are the precursors of colon cancer.
“We are committed to our mission of making the G-Eye a standard of care in colonoscopy,” CEO Gadi Terliuc said in a news 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.”
Smart Medical’s first G-Eye installation in the U.S. took place at NYU Langone Health in a collaboration with Fujifilm.
“Following the seamless and flawless integration of the G-EYE® into routine use at NYU Langone Health, we are confident it can become a natural and valuable tool for any GI practice, may it be academic, community hospital or an ambulatory endoscopy center,” chief commercial officer Brian Cochran said.