Boston Scientific Corp. has received a nod from the FDA for its high-voltage MR-safe labeling of the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The MR labeling indication comes about three months earlier than expected for the Marlborough, Mass.-based company. Boston Scientific said the favorable regulatory decisions were based on clinical results of the 500-patient ENABLE MRI trial, which was completed earlier this year. Read More
