Migraines have been a challenging condition to treat, often requiring patients to take powerful drugs with substantial side effects. Now the FDA has given the first permission to market a device in the U.S. to help prevent the onset of migraines. The Cefaly from STX-Med out of Liege, Belgium is a non-invasive headband that delivers transcutaneous electrical nerve stimulation (TENS) to the trigeminal nerve known to be involved in pathophysiology of migraine headaches. The device is worn for up to 20 minutes per day and is indicated for migraine sufferers 18 years of age or older. As with other TENS devices, there might be a tingling sensation and a muscle may even contract on its own in the head.
The device was cleared through FDA’s de novo review process for low risk devices that can’t go through the 510(k) substantial equivalence standard. Results of a study of 67 patients in Belgium with migraines that don’t take drugs to treat the condition, as well as a satisfaction survey from more than two thousand users in France and Belgium led to the FDA’s positive review of the Cefaly.
Here’s a company video explaining the product:
Product page: Cefaly…