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Medtronic Hopes For Speedy U.S. Launch Of Revo MRI-Friendly Pacer

This article was originally published in The Gray Sheet

Executive Summary

Medtronic is hoping to receive FDA approval of its Revo MRI SureScan MRI-safe pacemaker and launch it in the U.S. within six months now that the device has received a unanimous approval recommendation from an FDA advisory panel

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CMS has accepted Medtronic’s request to reconsider its recent final coverage decision preventing routine Medicare reimbursement for magnetic resonance imaging scans in patients with implanted pacemakers and defibrillators.

CMS Accepts Medtronic’s Request To Reconsider MRI/Pacemaker Policy

CMS has accepted Medtronic’s request to reconsider its recent final coverage decision preventing routine Medicare reimbursement for magnetic resonance imaging scans in patients with implanted pacemakers and defibrillators.

Medtronic Revo MRI Pacer Approved, But Still Faces Reimbursement Hurdle

Medtronic is hoping that the immediate U.S. launch of its newly approved Revo MRI SureScan MRI-compatible pacemaker will help boost market share in the device category, but magnetic resonance imaging scans of implant recipients still face a key reimbursement hurdle.

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