Smart Medical G-Eye colonoscope receives additional FDA clearance
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Smart Medical Systems Ltd. announced the FDA has approved its G-Eye colonoscope, based on Olympus 510(k)-cleared PCF colonoscope series.
According to a release from Smart Medical, the G-Eye is now available in the United States on colonoscope models from Olympus, Fujifilm and Pentax Medical endoscopy brands. The G-Eye colonoscope was remanufactured by Smart Medical to include a balloon at its distal bending section, which when moderately inflated during colonoscopy may aid in controlling the colonoscope’s view and positioning.
“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, said in the 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.”
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