SMART Medical Systems receives Additional FDA Clearance for its G-EYE® Colonoscope, and Commences Clinical Work in the USA
/SMART Medical has now commenced clinical collaboration with NYU Langone Health introducing its newly FDA-cleared G-EYE® 760 Colonoscope series, based on FUJIFILM Corporation's 510(k) cleared 760 colonoscopes and operating with Fujifilm's state-of-the-art ELUXEO imaging system
RA'ANANA, Israel, Feb. 16, 2021 /CNW/ -- SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced the initiation of commercial and clinical effort in the USA, following issuance of a second FDA clearance for its flagship G-EYE® Colonoscope, based on Fujifilm's 510(k) cleared colonoscopes.
The G-EYE® Colonoscope is a 510(k) cleared colonoscope, remanufactured by SMART to include a proprietary balloon at its distal bending section. SMART's FDA cleared G-EYE® Colonoscopes include selected models of the leading endoscope brands – Fujifilm, Olympus, and Pentax. Withdrawal of the G-EYE® Colonoscope with the balloon moderately inflated during colonoscopy, assists 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 (GIE 2019; 89: 545-553; and Endoscopy 2015; 47: 238–244).
The first G-EYE® installation in the USA took place at NYU Langone Health in collaboration with Fujifilm. Following initial procedures and live case demonstration during the NYSGE Annual Course's live endoscopy session, hosted by NYU Langone Health in December, the G-EYE® is being used in the NYU Langone endoscopy unit. "I am now using the G-EYE® integrated balloon to gain better stability of the scope during withdrawal and increase colon surface area exposure," said Dr. Seth Gross, Clinical Chief in the Division of Gastroenterology and Hepatology at NYU Langone Health. "The effect of the G-EYE® balloon has been shown in clinical studies to be a valuable and innovative new tool in the prevention and early detection of colorectal cancer." "We are excited to be the first medical center in the USA performing colonoscopy with the G-EYE® Colonoscope, and providing the newest-available technology to our patients," said Dr. Mark Pochapin, Director of the Division of Gastroenterology and Hepatology at NYU Grossman School of Medicine / NYU Langone Health.
Brian Cochrane, CCO of SMART's US subsidiary, said, "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."
"We are committed to our mission of making the G-EYE® a standard of care in colonoscopy," added Gadi Terliuc, SMART's CEO. "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."
Drs. Gross and Pochapin report no conflicts of interest with SMART Medical Systems.
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 partnership with Fujifilm and 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/.
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Contacts:
Brian Cochrane - CCO
+1-201-661-3795
bcochrane@smartmedsys.com
SOURCE Smart Medical Systems Ltd