IsoRay Inc. ISR -9.33% , a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced that the GliaSite(R) radiation therapy system, the world's only balloon catheter device used in the treatment of brain cancer, has earned the European CE Mark, allowing immediate sale in 31 European countries. The system's balloon catheter is a landmark technology that allows physicians to treat more patients than ever before with brachytherapy or internal radiation and provides important benefits over other radiation treatment options.
The CE mark designates that the manufacturer conforms with the essential product requirements of the applicable European Commission directives. Granted after a rigorous evaluation process, the CE mark allows a product to be legally marketed in the European Free Trade Association (EFTA) member states as well as the European Union.
IsoRay Chairman and CEO Dwight Babcock commented, "This is a major event for IsoRay as it opens the door to revenue opportunities in international markets where our current distributor previously marketed GliaSite(R) for its prior manufacturer. In addition, it allows us to pursue other distribution opportunities in countries not previously serviced. This historic moment completes the last requirement essential to initiate the international launch of our GliaSite(R) radiation therapy system".
source: IsoRay
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