Motus GI wins FDA nod for Pure-Vu slim colonoscopy sleeve

Motus GI said today that it won FDA 510(k) clearance for its Pure-Vu slim sleeve as part of its Pure-Vu system, intended for use during slim colonoscopies. With the clearance of the Pure-Vu slim sleeve, Motus GI said that the Pure-Vu system is now cleared for the full range of procedures in the colonoscopy market, with an estimated 30% of procedures performed with a slim colonoscope. The Pure-Vu slim sleeve was designed to be compatible with smaller diameters and more flexible slim colonoscopes and features additional enhancements to its low friction lubricious coating tech to aid in navigation, the Ft. Lauderdale, Fla.-based company said. “Having Pure-Vu compatible with slim colonoscopes will be critically important for patients with complex anatomy which can happen quite often in the inpatient setting. From my in vitro testing experience with the Pure-Vu Slim Sleeve on a slim colonoscope, the device had excellent handling and navigation performance,” Dr. Tamas Gonda of New York’s Columbia University Medical Center said in a prepared statement. “Receiving this special 510(k) clearance from the FDA for the Pure-Vu Slim Sleeve is an important milestone that will allow physicians to use the Pure-Vu System on slim colonoscopes which we estimate, through consultation with colonoscope manufacturing companies, are currently used in approximately 30% of procedures and growing in the United States. Pure-Vu Slim Sleeve was designed with the same stringent st...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance MOTUS GI Source Type: news