FDA Approves Migration-Prevention Device

WASHINGTON (March 11, 2014) The U.S. Food and Drug Administration says it has approved a nerve-stimulating headband as the first medical device to prevent migraine headaches.

The Cefaly device is a battery-powered plastic band worn across the forehead that emits an electric current to stimulate nerves associated with migraine pain.

It’s designed to be used no more than 20 minutes a day by patients who are 18 years and older.

A 67-person study reviewed by the FDA showed patients using the device experienced fewer migraines per month than patients using a placebo device.

The Cefaly did not completely eliminate migraine headaches or reduce the intensity of migraines that occurred.

About 53 percent of 2,313 patients in a separate study said they were satisfied with the device and willing to purchase it for future use.


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