Medtronic earns FDA approval for expanded MRI labelling

The new MRI labelling extends the active scan time for Medtronic DBS systems.

Medtronic has received U.S. Food and Drug Administration (FDA) approval of its expanded magnetic resonance imaging (MRI) labelling for Medtronic Percept PC and Percept RC, as well as Medtronic Activa PC, RC and SC.

The MRI labelling approval, exclusive to Medtronic Deep Brain Stimulation (DBS) systems according to the company, allows additional active scan time for scans below specified B1+rms limits, increasing the options available for diagnostic and functional assessments. Medtronic says it was the first medical device innovator in the U.S. to offer full-body MR Conditional DBS systems for patients to have safe scans anywhere on the body under specific conditions.

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