– FDA has accepted using G-EYE® with Olympus’ 510(okay) cleared PCF colonoscopes –
RA’ANANA, Israel, April 19, 2022 /PRNewswire/ — SMART Medical Methods Ltd., a developer and producer of modern endoscopy merchandise, in the present day introduced a further FDA clearance for its G-EYE® Colonoscope, primarily based on Olympus’ 510(okay) cleared PCF colonoscope sequence. With this extra FDA clearance, G-EYE® is now obtainable to be used within the U.S. market on the generally used colonoscope fashions of all three main endoscopy manufacturers – OLYMPUS, FUJIFILM, and PENTAX Medical.
“The power to supply G-EYE® on colonoscope manufacturers and fashions generally used and extensively obtainable in america is a vital milestone for SMART Medical, sufferers, and endoscopists,” mentioned Gadi Terliuc, Chief Government Officer of SMART Medical. “Nearly all of U.S. endoscopists now have the choice to make the most of our cutting-edge expertise, which has been proven in scientific research to enhance visualization in contrast with normal colonoscopy, whereas utilizing their most well-liked model and mannequin of colonoscope. We’re very excited to have accomplished our portfolio of U.S. G-EYE® choices and imagine that the widespread availability of the expertise on the generally used colonoscope fashions has the potential to speed up adoption of G-EYE® colonoscopy as the usual of care.”
The G-EYE® Colonoscope is a 510(okay) cleared colonoscope, remanufactured by SMART to incorporate a proprietary balloon at its distal bending part. Withdrawal of the G-EYE® Colonoscope with the balloon reasonably inflated throughout colonoscopy assists in controlling the colonoscope’s discipline of view and positioning. A printed research (GIE 2019; 89: 545-53) demonstrated that G-EYE® can enhance colonoscopy outcomes in contrast with normal colonoscopy throughout a number of metrics, together with rising adenoma detection fee (ADR) by 28%, detecting 47% extra adenomas per affected person (APP), 62% extra superior and enormous adenomas, and 142% extra flat adenomas.
“We anticipate that this FDA clearance of the G-EYE® Colonoscope primarily based on Olympus’ PCF scopes, which many Olympus customers choose over conventional adult-sized colonoscopes, will improve our skill to seize a considerable portion of the U.S. colonoscopy market,” mentioned Brian Cochrane, Chief Business Officer of SMART’s U.S. subsidiary. “We’re dedicated to turning into the usual of care in colonoscopy, and this FDA clearance is a vital step towards reaching this essential aim.”
About SMART Medical Methods
SMART Medical Methods is a pioneer within the improvement and manufacture of modern medical units within the discipline of gastro-intestinal (GI) endoscopy. SMART’s distinctive strategy is to deal with key challenges in modern endoscopy whereas utilizing obtainable model identify endoscopes. SMART’s CE Marked and FDA-cleared NaviAid™ and G-EYE® product households are commercially distributed in key international markets. With its partnership with FUJIFILM and PENTAX Medical, SMART’s G-EYE® colonoscopy resolution is at the moment adopted by two of the three business leaders in GI endoscopy imaging. SMART is headquartered in Israel, and operates in america by means of its wholly-owned subsidiary, SMART GI Inc. For extra info, please go to: www.smartmedsys.com/us/.
Glenn Silver, Lazar FINN
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SOURCE SMART Medical Methods