[Image from Smart Medical]
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 lumen once the colon is intubated.
When withdrawing the colonoscope, the balloon is moderately inflated to centralize the image of the colon lumen. It flattens colonic folds and reduces the amount of bowel slippage, according to the company.
“This FDA clearance is a cornerstone for our company”, CEO Gadi Terliuc said in a news release. “This important milestone, adding to our recently-formed strategic partnership with Fujifilm, is part of our evolution as a meaningful provider of enabling endoscopy products.”
G-Eye will be available on certain FDA 510(k) cleared Olympus and Pentax colonoscopes. It is currently preparing its 510(k) submission for use in Fujifilm devices.
“We are excited to have the G-Eye colonoscope available for American patients, doctors and endoscopy practices and are proud of taking part in the global effort to provide advanced technologies for colonoscopy,” chief commercial officer of the company’s U.S. subsidiary Brian Cochrane said. “We are now initiating our launch of the G-Eye colonoscope in the U.S. market, aiming to make it available to clinical collaborators and customers.”