Smart Medical Systems wins additional FDA clearance for G-Eye colonoscope

Image from Smart Medical

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…

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Smart Medical wins FDA clearance for G-Eye colonoscope

[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 prod…

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