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03-13-2014, 08:34 PM
Cefaly Mi*****e Preventing TENS Headband Coming to U.S. Market (VIDEO)
http://cdn.medgadget.com/wp-content/uploads/2014/03/Cefaly.jpg
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… (http://www.cefaly.com/)
Press release:*FDA allows marketing of first medical device to prevent mi*****e headaches… (http://www.fda.gov/NewsEvents/Newsroom/PressAn**uncements/ucm388765.htm)
http://feeds.feedburner.com/~ff/Medgadget?d=yIl2AUoC8zA (http://feeds.feedburner.com/~ff/Medgadget?a=9nUFA4Nlrjg:yJejaNqLtCY:yIl2AUoC8zA) http://feeds.feedburner.com/~ff/Medgadget?d=qj6IDK7rITs (http://feeds.feedburner.com/~ff/Medgadget?a=9nUFA4Nlrjg:yJejaNqLtCY:qj6IDK7rITs) http://feeds.feedburner.com/~ff/Medgadget?i=9nUFA4Nlrjg:yJejaNqLtCY:gIN9vFwOqvQ (http://feeds.feedburner.com/~ff/Medgadget?a=9nUFA4Nlrjg:yJejaNqLtCY:gIN9vFwOqvQ)
http://feeds.feedburner.com/~r/Medgadget/~4/9nUFA4Nlrjg
http://cdn.medgadget.com/wp-content/uploads/2014/03/Cefaly.jpg
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… (http://www.cefaly.com/)
Press release:*FDA allows marketing of first medical device to prevent mi*****e headaches… (http://www.fda.gov/NewsEvents/Newsroom/PressAn**uncements/ucm388765.htm)
http://feeds.feedburner.com/~ff/Medgadget?d=yIl2AUoC8zA (http://feeds.feedburner.com/~ff/Medgadget?a=9nUFA4Nlrjg:yJejaNqLtCY:yIl2AUoC8zA) http://feeds.feedburner.com/~ff/Medgadget?d=qj6IDK7rITs (http://feeds.feedburner.com/~ff/Medgadget?a=9nUFA4Nlrjg:yJejaNqLtCY:qj6IDK7rITs) http://feeds.feedburner.com/~ff/Medgadget?i=9nUFA4Nlrjg:yJejaNqLtCY:gIN9vFwOqvQ (http://feeds.feedburner.com/~ff/Medgadget?a=9nUFA4Nlrjg:yJejaNqLtCY:gIN9vFwOqvQ)
http://feeds.feedburner.com/~r/Medgadget/~4/9nUFA4Nlrjg