The Cefaly headband "provides an alternative to medication for migraine prevention,‚?Ě the FDA says. / Cefaly Technology
NASHVILLE, Tenn. -- It may look like a crown for a princess from the future, but the headband is actually a medical treatment.
The U.S. Food and Drug Administration has approved marketing of the first device to prevent migraine headaches. The headband is called Cefaly.
Migraine headaches affect 10 percent of people worldwide and are three times more common in women than men, according to the National Institutes of Health.
"Cefaly provides an alternative to medication for migraine prevention," said 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 device is manufactured by a Belgium-based company.
"The FDA approval of the Cefaly medical device is a significant milestone for Cefaly Technology and for migraine patients across the United States," said Pierre Rigaux, the chief executive officer of the company. "It means for many episodic migraine sufferers, preventive relief is just 20 minutes away."
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