Motus GI (NSDQ:MOTS) today announced it has received FDA 510(k) clearance for the second-generation of its Pure-Vu colonoscopy device.
Fort Lauderdale, Fla.-based Motus designed the original Pure-Vu device to attach to standard and slim colonoscopes to deliver a mixture of water and air to remove debris when patients haven’t completed their bowel prep. Pure-Vu GEN2 has been designed to improve the mobility, setup logistics of the system and enhance navigation through the colon, while retaining all the same cleansing functionality as the system’s first generation.
“Inadequate bowel preparation prior to colonoscopy remains an unmet need that affects a significant percentage of patients’ ability to receive a complete and high-quality exam,” Dr. Jason Samarasena, associate clinical professor of medicine at the University of California Irvine School of Medicine’s gastroenterology division, said in a news release. “This often leads to canceled, delayed and aborted procedures, resulting in prolonged hospitalizations and increased costs for both patients and providers.”
“Receiving FDA clearance for our Pure-Vu GEN2 represents a major milestone for the company,” said Motus GI CEO Tim Moran. “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.”
The initial launch will focus on the inpatient colonoscopy market, where the company said that challenges with insufficient bowel prep can slow diagnosis, diminish the quality of care and add significant costs to hospital systems.