Medtronic receives CE mark for its Pacing System
Medtronic Inc. has received CE (Conformité Européenne) Mark for the first-ever MR-Conditional pacemaker system, the EnRhythm MRI TM SureScan TM pacemaker and CapSureFix MRI TM SureScan TM pacing leads (Model 5086MRI). The new system was designed, tested and approved for use with magnetic resonance imaging (MRI) under specified scanning conditions, and is now commercially available in select European countries. Patients receiving the EnRhythm MRI SureScan Pacing System will for the first time be able to undergo MRI scans under certain conditions, representing a major milestone in the evolution of implantable cardiac devices.

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The U.S. Food and Drug Administration has granted the 501(k) clearance to Aurora Imaging Technology Inc.’s Aurora® 1.5Tesla Dedicated Breast MRI System for AuroraSPECTROSCOPY™, the company’s package of breast magnetic resonance (MR) spectroscopy. The package was developed as an add-on for the Aurora Breast MRI in order to enhance the image specificity of this innovative technology. It continues to be the only dedicated breast MRI system cleared by FDA which is specifically designed to detect, diagnose and manage breast disease alone.