The US Food and Drug Administration (FDA) has cleared Crospon's EndoFLIP system for use in gastroenterology applications.
The EndoFLIP system utilizes the new Barostat software to include pressure and dimension measurements taken in the esophagus, in addition to measurements taken during gastric band and sleeve gastrectomy bariatric surgery procedures.
The pressure and dimension measurements are considered as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.
Crospon CEO John O’Dea said the FDA clearance allows the comopany to market its EndoFLIP system in the USA for gastroenterology applications.
"Not only is this the Company’s first cleared application for gastroenterology, but it also represents the first reimbursed application for the product," O’Dea added.