Irish medical device maker Crospon entered the gastroenterology market with FDA clearance to expand its EndoFlip imaging device to esophageal procedures.
The EndoFlip device is a functional lumen imaging probe used to measure the dimensions and function of hollow organs.
The system was previously cleared for use in during gastric band and sleeve gastrectomy bariatric surgery.
The company’s new clearance extends to evaluation of patients with esophageal sensory hypersensitivity using Crospon’s new Barostat software option.
"This clearance is important for Crospon as it, for the 1st time, allows us to market the EndoFlip system in the USA for gastroenterology applications," CEO John O’Dea said in prepared remarks. "Not only is this the company’s 1st cleared application for gastroenterology, but it also represents the 1st reimbursed application for the product."
All new EndoFlip devices will include the Barostat software option, according to a press release.