Crospon receives CE Mark certification for EndoFLIP® System
EndoFLIP® system on track for First Quarter release to European Market
Tuesday 20 January 2009 – Crospon, a medical device developer based in Galway, Ireland today
announced that its EndoFLIP® system has received CE Mark certification from the NSAI (National
Standards Authority of Ireland), the Irish Notified Body, in accordance with the European Medical Device Directive.
Crospon Limited develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy the gastroenterology area. Commenting on the certification, John O’Dea, CEO Crospon Ltd, said, “Today’s announcement is an important step in the company’s development and ensures Crospon remains on schedule to release the EndoFLIP® system into the European market by the end of the first quarter of 2009.”
In December 2008, Crospon announced that it had completed an additional €500,000 funding round,
following on from the completion of a €3m round of financing earlier that year. This additional funding
will be primarily used for the completion of development, manufacturing startup and preparation to
market of the EndoFLIP® system. EndoFLIP® is used to enhance diagnosis and assist in the surgical
treatment of gastroesophageal reflux disorder (GERD). For further information please view
www.EndoFLIP®.com. The EndoFLIP® system is the first is a range of products the company plans to bring to market.
CE Marking on a product is a manufacturer’s declaration that the product complies with the essential
requirements of the relevant European health, safety and environmental protection legislation. The
Medical Devices Directives set out essential requirements to ensure that a medical device will not
compromise the health and safety of the patient, user of any other person and that any risks associated with the device are compatible with patient health and protection.
Speaking at the launch of NSAI’s new two-year strategy document earlier this month, Maurice Buckley, Chief Executive of the NSAI emphasised the importance of recognised standards. “Gaining international certifications and standards such as the CE mark, can give Irish businesses a competitive advantage by providing assurance to global consumers that Irish goods or services are following the best international standards.”