FDA Approves MRI-Safe Second Generation Pacemaker System

The FDA approved Medtronic’s Advisa DR MRI SureScan system, an MRI-safe second generation pacemaker system. To date, the first and second generation SureScan systems are the only pacemakers on the U.S. market that are MRI-approved. CMS will only coverExternal Link MRIs in patients with these approved devices.

Keywords: Centers for Medicare and Medicaid Services, U.S., Device Approval, Magnetic Resonance Imaging, Pacemaker, Artificial, United States

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