An Irish medical devices technology firm has received the vital CE Mark certification it needs to allow it to release a revolutionary new technology in time for the second quarter of this year.
Galway-based Crospon, which has developed a system called EndoFLIP a leading- edge minimally invasive medical device for monitoring, diagnosis and therapy in the gastroenterology area.
“TThis 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,” Crospon’s CEO, John O’Dea, commented.
Last year, Crospon also secured a cross-licensing deal with HP to enable the commercial rollout of a drug-delivery platform that will help to replace hypodermic needles, it emerged yesterday. Under the agreement, HP will license its intellectual property to Crospon in return for royalty payments.
In December, 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 start up 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).
A CE Mark 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,” Buckley said.
Caption: Brendan McDermott, regional director, Ulster Bank, pictured presenting the ‘One to Watch’ award to John O’Dea, CEO, Crospon, at the Ulster Bank Business Achievers Awards 2008
By John Kennedy