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Device to Improve Cleansing for Colonoscopy Receives FDA Clearance
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The FDA has given 510(k) clearance to the second generation of Motus GI’s Pure-Vu System, which helps provide adequate cleansing of a poorly prepared colon during a colonoscopy screening.
“Receiving FDA clearance for our Pure-Vu GEN2 represents a major milestone for the company,” Motus CEO Tim Moran said in a press release. “The Pure-Vu System continues to demonstrate outstanding cleansing performance in poorly prepped colons, including the statistically significant improvement in colon cleanliness in hospitalized patients as recently demonstrated by the positive outcome of our REDUCE study.”
The device connects to standard and slim colonoscopes, and recent studies have shown it provides adequate cleansing during procedures.
The second generation Pure-Vu system has improved mobility and has been designed to streamline setup, as well as enhance navigation of the colon, according to the release.
“With our robust portfolio of health economic and clinical data coupled with 510(k) clearance from the FDA of Pure-Vu GEN2, we are now well positioned to execute our planned commercial launch of the Pure-Vu System this year and advance toward our goal of establishing the Pure-Vu System as a new standard of care in key endoscopy segments,” Moran said in the release.
Disclosures: Moran is employed by Motus GI.