FDA Clears MRI-Safe Pacemaker

David Rosenfeld | | Radiology Business | Magnetic Resonance Imaging
The Food and Drug Administration recently approved the first pacemaker that can safely be used in certain types of MRI exams. The device known as Revo-MRI is made by Medtronic, and it offers a switch that can be turned on in preparation for an MRI. About half of all patients currently with pacemakers may require an MRI but are advised against it because the magnetic fields interfere with the devices, according to the FDA in a recent press release. FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI.” The FDA based its approval on a single clinical trial of 484 patients, of which 464 were successfully implanted with the Revo device. An MRI was administered to 211 patients and none experienced MRI-related complications, based on the FDA release. As part of its approval the FDA is requiring training for cardiologists and radiologist.

David Rosenfeld

Related Content

Nearly $800,000 settlement offered to family of man who died during MRI exam
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage
Siemens Healthineers inks 10-year, $105M imaging value partnership with large medical center
CMS approves new MRI standards related to remote scanning
Radiologists are more accurate, confident when they know the full story
Rads are more accurate when they have access to patients' self-reported symptoms

Around the web

Health Imaging
Nearly $800,000 settlement offered to family of man who died during MRI exam

The patient, who was being cared for in the ICU, was not accompanied or monitored by nursing staff during his exam, despite being sedated.

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.