Devices Gastroenterology Oncology FDA

 News Release - May 26, 2020

SMART Medical Systems Receives FDA Clearance for Its G-EYE(R) Colonoscope

SMART's G-EYE® Colonoscope, incorporating the G-EYE® Balloon Technology which helps control the endoscope's field of view and positioning during colonoscopy, was cleared for marketing in the USA by FDA

RA'ANANA, Israel, May 26, 2020 -- (Healthcare Sales & Marketing Network) -- SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its flagship product, the G-EYE® Colonoscope.

The G-EYE® colonoscope is a standard colonoscope which SMART remanufactures by installing its proprietary G-EYE® balloon on the distal bending section of the colonoscope. During colonoscopy, the G-EYE® colonoscope is inserted in the standard technique, with the balloon deflated. Once the colon is intubated and prior to withdrawal, the balloon is inflated to engage the colon lumen. Withdrawal of the G-EYE® Colonoscope through the colon with the balloon moderately inflated centralizes the image of the colon lumen, flattens colonic folds, and reduces the amount of bowel slippage, thereby assisting in controlling the colonoscope's field of view and positioning. In published clinical studies comparing adenoma detection rate of G-EYE® colonoscopy to that of standard colonoscopy, G-EYE® colonoscopy demonstrated substantial increase in the detection of cancerous polyps which are the precursors of colon cancer (GIE 2019; 89: 545-553; and Endoscopy 2015; 47: 238–244).

Under the current FDA clearance, the G-EYE® colonoscope will be available based on selected 510(k) cleared colonoscopes of OLYMPUS (8 models) and PENTAX Medical (3 models). SMART is currently preparing its 510(k) submission for the FUJIFILM brand.

"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", said Brian Cochrane, CCO of SMART's US subsidiary. "We are now initiating our launch of the G-EYE® colonoscope in the US market, aiming to make it available to clinical collaborators and customers".

"This FDA clearance is a cornerstone for our company", said Gadi Terliuc, SMART's CEO. "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".

About SMART Medical Systems

SMART Medical Systems is a pioneer in the development and manufacture of innovative medical devices in the field of gastro-intestinal (GI) endoscopy. SMART's unique approach is to use available brand name endoscopes and address key challenges in contemporary endoscopy. SMART's CE Marked and FDA cleared NaviAid™ product family is commercially distributed in key global markets. With its new partnership with FUJIFILM adding to its already existing alliance with PENTAX Medical, SMART's G-EYE® colonoscopy solution is currently adopted by two of the three industry leaders in GI endoscopy imaging. SMART is headquartered in Israel, and operates in the United States through its wholly-owned subsidiary, SMART GI Inc. For more information, please visit: www.smartmedsys.com/us/

Source: SMART Medical Systems

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