Interventional and ultrasound technology developer Boston Scientific has received the CE Mark for MRI-conditional labeling for cardioverter defibrillators.
The regulatory nod applies to the company's current family of Extended Longevity (EL) and Mini implantable cardioverter defibrillators, as well as the X4 cardiac resynchronization therapy defibrillator systems.
The revised labeling, referred to as ImageReady, ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated, Boston Scientific said.
In addition, the firm is seeking regulatory approvals for revised labeling and updated software for its systems in major markets by 2017, as MRI compatibility has not received regulatory approval in all geographies.
