Crospon gets FDA clearance for new product

A new product developed by a local medical device company will provide an improved diagnostic test for gastroesophageal reflux disease (GERD ).

The EndoFLIP® technology was designed by Crospon which is based at Galway Business Park and was set up in 2006. It develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area.

The tool was developed to provide a more physiologically relevant diagnostic test for gastroesophageal reflux disease. Chronic GERD is a prevalent disorder reaching epidemic proportions worldwide. It manifests itself as severe heartburn caused by stomach acid refluxing into the oesophagus.

Crospon’s development of the EndoFLIP® system was recognised with the 2009 European Gastroenterology Technology Implementation of the Year Award, the Overall Medical Technology Excellence Award and the Gold Award for Innovation, Research and Development at the Irish Medical Device Association Awards.

Obtaining FDA clearance for the EndoFLIP® device was a significant milestone in the product’s development, according to company chief executive John O’Dea.

“This will allow the company to sell it in the US market. It will also assist it in continuing to build the clinical evidence base to support wider indications for use of the product, particularly in bariatric [weight loss] surgery.

 

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