SMART Medical Systems' G-EYE (R) Colonoscope is now FDA Cleared on Olympus' PCF Colonoscope Series, Making it Available in the United States
PR95527
SMART Medical Systems' G-EYE (R) Colonoscope is now FDA Cleared on Olympus' PCF Colonoscope Series, Making it Available in the United States on the Commonly Used Models of All Leading Endoscopy Brands
RA'ANANA, Israel, April 19, 2022 /PRNewswire=KYODO JBN/ --
- FDA has approved the use of G-Eye (R) with Olympus' 510(k) cleared PCF
colonoscopes –
SMART Medical Systems Ltd., a developer and manufacturer of innovative
endoscopy products, today announced an additional FDA clearance for its G-EYE
(R) Colonoscope, based on Olympus' 510(k) cleared PCF colonoscope series. With
this additional FDA clearance, G-EYE (R) is now available for use in the U.S.
market on the commonly used colonoscope models of all three leading endoscopy
brands - OLYMPUS, FUJIFILM, and PENTAX Medical.
Logo - https://mma.prnewswire.com/media/1669152/smart_Logo.jpg
"The ability to offer G-EYE (R) on colonoscope brands and models commonly used
and widely available in the United States is an important milestone for SMART
Medical, patients, and endoscopists," said Gadi Terliuc, Chief Executive
Officer of SMART Medical. "The majority of U.S. endoscopists now have the
option to utilize our cutting-edge technology, which has been shown in clinical
studies to improve visualization compared with standard colonoscopy, while
using their preferred brand and model of colonoscope. We are very excited to
have completed our portfolio of U.S. G-EYE (R) offerings and believe that the
widespread availability of the technology on the commonly used colonoscope
models has the potential to accelerate adoption of G-EYE (R) colonoscopy as the
standard of care."
The G-EYE (R) Colonoscope is a 510(k) cleared colonoscope, remanufactured by
SMART to include a proprietary balloon at its distal bending section.
Withdrawal of the G-EYE (R) Colonoscope with the balloon moderately inflated
during colonoscopy assists in controlling the colonoscope's field of view and
positioning. A published study (GIE 2019; 89: 545-53) demonstrated that G-EYE
(R) can improve colonoscopy outcomes compared with standard colonoscopy across
several metrics, including increasing adenoma detection rate (ADR) by 28%,
detecting 47% more adenomas per patient (APP), 62% more advanced and large
adenomas, and 142% more flat adenomas.
"We expect that this FDA clearance of the G-EYE (R) Colonoscope based on
Olympus' PCF scopes, which many Olympus users prefer over traditional
adult-sized colonoscopes, will enhance our ability to capture a substantial
portion of the U.S. colonoscopy market," said Brian Cochrane, Chief Commercial
Officer of SMART's U.S. subsidiary. "We are committed to becoming the standard
of care in colonoscopy, and this FDA clearance is an important step toward
achieving this critical goal."
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 address key challenges in contemporary endoscopy
while using available brand name endoscopes. SMART's CE Marked and FDA-cleared
NaviAid (TM) and G-EYE (R) product families are commercially distributed in key
global markets. With its partnership with FUJIFILM and PENTAX Medical, SMART's
G-EYE (R) 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/ .
Media Contact:
Glenn Silver, Lazar FINN
Glenn.silver@finnpartners.com
+1 (973) 818-8198
SOURCE: SMART Medical Systems
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