www.fdanews.com/articles/176292-boston-scientific-receives-ce-marking-for-emblem-s-icd-systems
Boston Scientific Receives CE Marking for EMBLEM S-ICD Systems
April 20, 2016
Device giant Boston Scientific has been granted CE marking for its Emblem MRI subcutaneous implantable defibrillator system, along with magnetic resonance conditional labeling for all implanted Emblem S-ICD systems.
The system is designed to minimize the risk of complications linked to transvenous implantable cardioverter-defibrillators in patients at risk of sudden cardiac arrest that leaves the heart and vasculature unharmed.
A full European launch is expected early this summer, the company says. The product is not available in the U.S. — Anisa Jibrell