Crospon, a medical device developer based in Ireland, has announced it has received FDA clearance for the use of its EndoFLIP system in gastroenterology applications, according to a news release.
The EndoFLIP (endolumenal functional lumen imaging probe) imaging system is used to measure the dimensions and function of a variety of hollow organs, vessels and sphincteric regions throughout the body, according to the company.
The new clearance extends the FDA cleared uses for the EndoFLIP system to now include pressure and dimension measurements taken in the esophagus and as an adjunct to other methods in the evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.
"This clearance is important for Crospon as it, for the first time, allows us to market the EndoFLIP system in the [United States] for gastroenterology applications," said John O'Dea, CEO of Crospon. "Not only is this the company's first cleared application for gastroenterology, but it also represents the first reimbursed application for the product."
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