Sam Brusco, Associate Editor04.19.22
Endoscopy products maker SMART Medical Systems has gained U.S. Food and Drug Administration (FDA) clearance for its G-EYE colonoscope based on Olympus’ 510(k)-cleared PCF colonoscope series.
This additional FDA nod makes G-EYE available in the U.S. on commonly used colonoscope models from Olympus, Fujifilm, and Pentax Medical.
"The ability to offer G-EYE on colonoscope brands and models commonly used and widely available in the United States is an important milestone for SMART Medical, patients, and endoscopists," Gadi Terliuc, CEO of SMART Medical told the press. "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 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 colonoscopy as the standard of care."
G-EYE is a 510(k)-cleared colonoscope remanufactured by SMART with a proprietary balloon at the distal bending section. Withdrawing G-EYE with balloon moderately inflated during colonoscopy helps control the field of view and positioning.
A published study showed G-EYE can improve outcomes compared to standard colonoscopy. Adenoma detection rate increased 28%—47% more adenomas per patient were spotted, 62% more advanced and large adenomas, and 142% more flat adenomas.
"We expect that this FDA clearance of the G-EYE 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."
This additional FDA nod makes G-EYE available in the U.S. on commonly used colonoscope models from Olympus, Fujifilm, and Pentax Medical.
"The ability to offer G-EYE on colonoscope brands and models commonly used and widely available in the United States is an important milestone for SMART Medical, patients, and endoscopists," Gadi Terliuc, CEO of SMART Medical told the press. "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 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 colonoscopy as the standard of care."
G-EYE is a 510(k)-cleared colonoscope remanufactured by SMART with a proprietary balloon at the distal bending section. Withdrawing G-EYE with balloon moderately inflated during colonoscopy helps control the field of view and positioning.
A published study showed G-EYE can improve outcomes compared to standard colonoscopy. Adenoma detection rate increased 28%—47% more adenomas per patient were spotted, 62% more advanced and large adenomas, and 142% more flat adenomas.
"We expect that this FDA clearance of the G-EYE 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."