Noninvasive Vagus Nerve Stimulator Receives FDA Clearance for Adjunctive, Preventive Treatment of Adult Cluster Headache

The FDA granted 510(k) clearance for an expanded label for noninvasive vagus nerve stimulator (nVNS; gammaCore, electroCore) therapy for adjunctive use for the preventive treatment of cluster headache in adult patients. It is the first product the FDA has cleared for the prevention of cluster headache. There are no FDA-approved pharmacologic treatments for the prevention of cluster headache.

nVNS emits a mild electrical stimulation to the vagus nerve that passes through the skin. It can be