Crospon gets further FDA clearance for its system in the US
Crospon gets further FDA clearance for its system in the US
CEO of Crospon John O’Dea
Galway-based medical device developer Crospon has received clearance from the Food and Drug Administration (FDA) in the US for the use of its EndoFLIP system in gastroenterology applications.
CEO of Crospon John O’Dea said this clearance was important for Crospon as it allows it to market the EndoFLIP system in the US for gastroenterology applications for the first time.
“Not only is this the company’s first cleared application for gastroenterology, but it also represents the first reimbursed application for the product.”
The newly cleared Barostat software option extends the FDA cleared uses for the system beyond measurements taken during gastric band and sleeve gastrectomy bariatric surgery procedures.
They now include pressure and dimension measurements taken in the oesophagus and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with oesophageal sensory hypersensitivity.
All new EndoFLIP systems will include the Barostat software option.
Established in 2006, Crospon was recently awarded the 2012 European Enabling Technology Award for Surgical Imaging Technology by Frost & Sullivan.