Cefaly Mi*****e Preventing TENS Headband Coming to U.S. Market (VIDEO)
 

Cefaly Mi*****e Preventing TENS Headband Coming to U.S. Market (VIDEO)
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Mi*****es have been a challenging condition to treat, often requiring patients to take powerful ***** with substantial side effects. **w the FDA has given the first permission to market a device in the U.S. to help prevent the onset of mi*****es. The Cefaly from*STX-Med out of*Liege, Belgium is a **n-invasive headband that delivers*transcutaneous electrical nerve stimulation (TENS) to the*trigeminal nerve k**wn to be involved in pathophysiology of mi*****e headaches. The device is worn for up to 20 minutes per day and is indicated for mi*****e 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 **vo 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 mi*****es that don’t take ***** 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 view explaining the product:





Product page: Cefaly…

Press release:*FDA allows marketing of first medical device to prevent mi*****e headaches…

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