FDA approves MR-conditioning labeling for Abbott’s pacemaker

Tim Casey | | Cardiovascular Business | Heart Rhythm

The FDA approved a magnetic resonance (MR)-conditioning labeling for Abbott’s Assurity MRI pacemaker and its Tendreil MRI pacing lead.

Abbott announced the approval in a news release on Feb. 1.

Patients implanted with the devices can now undergo full-body MRI scans. The company also mentioned the Assurity MRI pacemaker offers wireless remote monitoring.

Abbott said it plans on seeking more MR-conditioning labeling for its pacemakers, implantable cardioverter defibrillators and cardiac resynchronization therapy devices.

St. Jude Medical developed the Assurity MRI pacemaker. On Jan. 4, Abbott completed its acquisition of St. Jude Medical for approximately $25 billion.

Tim Casey,

Executive Editor

Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.

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