FDA Approves Migraine 'Headband' for Marketing

The U.S. Food and Drug Administration approved Herstal, Belgium-based STX-Med to market Cefaly, the first medical device offering preventative treatment for migraines.

Cefaly is also the first transcutaneous electrical nerve stimulation device authorized for use before the onset of pain.

The device resembles a headband and is worn across the forehead and on top of the ears. It releases an electric current to the skin that reaches the tissue and stimulates branches of the trigeminal nerve, a nerve associated with migraines.

Cefaly is only approved for use for patients at least 18 years old, and should only be used once a day for 20 minutes.

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