Smart Medical Systems this week announced that its G-Eye colonoscope received FDA 510(k) clearance for use with Olympus’ PCF colonoscope series.
The G-Eye is now available for use 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,” CEO Gadi Terliuc said in a news release. “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.”
Israel-based Smart Medical Systems designed the G-Eye colonoscope with a proprietary balloon at its distal bending section. The balloon is moderately inflated during a colonoscopy to assist in controlling the colonoscope’s field of view and positioning, according to the company.
“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.”