FDA Grants Expanded Clearance for Vagus Nerve Stimulator

ElectroCore has received an expanded 510(k) marketing clearance for its gammaCore non-invasive vagus nerve stimulator, clearing the device for treating migraines in patients aged 12 to 17.

The device can now be used for treatment of most forms of primary headache in adolescents and adults. It is also cleared for acute and preventive treatment of cluster headache in adults.

The gammaCore device, which delivers mild electrical stimulation to the vagus nerve to reduce pain, is the first non-invasive, handheld treatment applied at the neck as an adjunctive therapy for migraines and cluster headaches, the company said.