Biotronik gets FDA go-ahead for MRI-safe pacemaker trial
January 16, 2013 by MassDevice staff
The FDA grants an investigational device exemption to Biotronik for a clinical trial examining its MRI-safe Entovis pacemaker technology.
The FDA approved a clinical trial of Biotronik's Entovis MRI-safe pacemaker, granting an investigational device exemption to the German medical device company.
Biotronik said it's already enrolling subjects for the 245-patient trial, which will aim to determine the safety and efficacy of the device during MRI scans.
News Well, Investigational Device Exemption (IDE), Cardiac Rhythm Management, Imaging, Regulatory/Compliance
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