Cefaly, a headband used in the treatment of migraines, has received FDA approval.
It now can be marketed in the United States.
Cefaly treats migraines through neurostimulation. To use it, an accompanying adhesive electrode is positioned on the forehead, and Cefaly is then connected to it. Cefaly generates precise micro-impulses through the electrode to stimulate the nerve endings of the trigeminal nerve. Cefaly sessions last twenty minutes.
“Cefaly provides an alternative to medication for migraine prevention,” says Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
The Cefaly headband requires a prescription and costs $295. Its electrodes can be used up to 20 times. Electrodes are sold in sets of three for $25. Cefaly and its electrodes can be bought directly from the Cefaly website.
Source: USA Today