FDA Clears Neurolief’s Noninvasive Migraine Headset

The FDA has granted 510(k) clearance for Neurolief’s Relivion system, a noninvasive brain neuromodulation device for treating acute migraine.

The device can be used at home and is worn as a headset to deliver personalized treatment to patients who experience acute migraines. It delivers stimulation to six branches of the occipital and trigeminal nerves, using three output channels.

According to the company, the system is the first and only neuromodulation technology that has shown statistically significant efficacy in eliminating migraine symptoms within two hours after treatment.