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Medical Devices / Submissions and Approvals

ElectroCore’s Nerve Stimulator Receives Expanded Clearance for Treating Cluster Headaches

Nov. 30, 2018
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The FDA granted 510(k) clearance for an expanded label for ElectroCore’s GammaCore non-invasive vagus nerve stimulator therapy for the preventive treatment of cluster headache in adults.

Also known as “suicide headaches,” cluster headaches last a relatively short time but cause extreme pain, affecting approximately 350,000 patients in the US.

The device is the only product cleared by the FDA for prevention of cluster headache and is only available through prescription.

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