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New Product Briefs: MRI-Safe Neurostim; Integra, Stereotaxis, IntelligentMDx Gain 510(k)s

Medtronic launches conditionally MRI-safe RestoreSensor SureScan MRI system in the U.S. FDA clears Integra Lifescience Titan reverse shoulder system, Stereotaxis Vdrive catheter navigator and IntelligentMDx VRE test. More new products.

Medtronic PLC has launched the RestoreSensor SureScan MRI neurostimulation systems for full body MRI, the company announced Aug. 6. The four systems that use the company’s SureScan MRI technology are the first implantable neurostimulation devices for chronic back and limb pain to receive the designation of MRI conditionally safe. Previously, patients would need to have their neurostimulation device removed to receive an MRI. Medtronic says the device uses specially designed leads and has a feature that reprograms the device for the MRI environment. FDA approved the new devices for marketing in March. The guidelines for use include a six-step checklist for doctors to follow before giving patients with the device an MRI. The company’s second generation MRI-safe pacemaker also received FDA approval this year. (See Also see "New Products In Brief" - Medtech Insight, 18 February, 2013..)

RestoreSensor SureScan MRI neurostimulator

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