In a first, the FDA has approved a medical device designed to prevent migraine headaches. Designed by Cefaly Technology in Belgium, the product, dubbed Cefaly, is a small, portable, battery-powered plastic headband worn across the forehead and just above the ears. It stays in place in the center of the forehead by way of a self-adhesive electrode, and delivers an electrical current to stimulate branches of the trigeminal nerve, which doctors previously connected to migraine headaches. Regulators noted that Cefaly is also the first transcutaneous electrical nerve stimulation device specifically approved for use before the onset of pain. Patients can obtain the device by prescription.
Source: www.fiercemedicaldevices.com; Mark Hollmer; March 12, 2014.