FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

LiveNova’s Epilepsy Device Gets Expanded Approval for Use With MRIs

June 30, 2017
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The FDA granted an expanded approval for LiveNova’s AspireHC and AspireSRvagus nerve stimulation devices to allow use in combination with MRIs.

The devices prevent or shorten seizures in patients with drug-resistant epilepsy by sending mild pulses to the vagus nerve.

Previously, the device could only be used with special MRI equipment. Under the expanded access, the AspireHC and AspireSR models can now be used with any MRI.

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