– FDA has permitted using G-EYE® with Olympus’ 510(okay) cleared PCF colonoscopes –
RA’ANANA, Israel, April 19, 2022 /PRNewswire/ — SMART Medical Techniques Ltd., a developer and producer of revolutionary endoscopy merchandise, at the moment introduced an extra 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 broadly obtainable in the US is a vital milestone for SMART Medical, sufferers, and endoscopists,” mentioned Gadi Terliuc, Chief Govt Officer of SMART Medical. “The vast majority of U.S. endoscopists now have the choice to make the most of our cutting-edge know-how, which has been proven in scientific research to enhance visualization in contrast with customary colonoscopy, whereas utilizing their most popular 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 know-how 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 area of view and positioning. A printed research (GIE 2019; 89: 545-53) demonstrated that G-EYE® can enhance colonoscopy outcomes in contrast with customary 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 count on that this FDA clearance of the G-EYE® Colonoscope primarily based on Olympus’ PCF scopes, which many Olympus customers favor 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 changing into the usual of care in colonoscopy, and this FDA clearance is a vital step towards reaching this important purpose.”
About SMART Medical Techniques
SMART Medical Techniques is a pioneer within the growth and manufacture of revolutionary medical units within the area of gastro-intestinal (GI) endoscopy. SMART’s distinctive method is to deal with key challenges in up to date 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 world markets. With its partnership with FUJIFILM and PENTAX Medical, SMART’s G-EYE® colonoscopy answer is at the moment adopted by two of the three business leaders in GI endoscopy imaging. SMART is headquartered in Israel, and operates in the US via its wholly-owned subsidiary, SMART GI Inc. For extra data, please go to: www.smartmedsys.com/us/.
Glenn Silver, Lazar FINN
+1 (973) 818-8198
SOURCE SMART Medical Techniques