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Medical News & Perspectives
March 9, 2011

First MRI-Safe Pacemaker Receives Conditional Approval From FDA

JAMA. 2011;305(10):985-986. doi:10.1001/jama.2011.273

Using magnetic resonance imaging (MRI) on patients with implantable electrical pacemaker devices has been contraindicated because of interactions that may increase the risk of serious adverse events. But now, the US Food and Drug Administration (FDA) has conditionally approved a pacemaker considered MRI-safe under certain parameters.

The approval, announced February 8, limits the device's use in MRIs to certain patients, imaging of certain parts of the body, under certain scanning parameters. Also, health professionals must undergo training to use the pacing system, the FDA said.

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