Regulatory Focus™ > News Articles > Irish Developer Gets FDA Clearance for Device Uses

Irish Developer Gets FDA Clearance for Device Uses

Posted 31 August 2012 | By

The U.S. Food and Drug Administration has granted clearance of new uses for a gastroenterological system from Ireland.

Crospon, based in Galway, Ireland, made the announcement and said the EndoFLIP system can be marketed in the U.S. for gastroenterology applications. The newly cleared Barostat software option extends current uses for the system beyond measurements taken during gastric band and sleeve gastrectomy bariatric surgery procedures, according to a company release.

All new EndoFLIP systems will include the software option, which will also measure pressure and dimension in the esophagus and assist in the evaluation of patents who have symptoms of esophageal sensory hypersensitity.

"Not only is this the company's first cleared application for gastroenterology, but it also represents the first reimbursed application for the product," CEO John O'Dea said in the release.

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