FDA-Approved Migraine Device – CEFALY

Renowned for helping prevent migraine attacks, a new FDA clearance paves way for more CEFALY devices that can now stop a migraine in progress and prevent a future episode too.

CEFALY Technology announces today the release of two new U.S. Food and Drug Administration (FDA)-cleared migraine treatment devices. CEFALY®, already the first FDA-approved external trigeminal nerve stimulation (e-TNS) device for the prevention of migraine attacks, is now the only migraine device available for use during a migraine attack with or without aura.

“We are excited that we can now offer migraine patients several drug-free options in their migraine care,” said Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology, and a member of the team that invented the device.  “We have developed a way for migraine patients to stop a migraine and prevent a migraine without medication and with next-to-no side effects.”

The new FDA-approval follows several clinical trials that demonstrated that one hour of e-TNS with the CEFALYy® device can relieve or stop the migraine headache. Results from the acute treatment of migraine with external trigeminal nerve stimulation double-blind randomized placebo control trial were presented at a recent meeting of the International Headache Society. The findings showed that on average, the CEFALY® treatment reduced migraine pain by 65%. In addition, 32% of patients were pain free within an hour.

Proprietary CEFALY® technology has been adapted to efficiently and safely address the different phases of migraines. Our Connected model brings together two treatment options in a singular device as well as a bluetooth-connected integration with our CeCe app, combining treatment options with tracking tools for an all inclusive treatment plan.

Despite these differences, the devices are administered in the same way: a device is placed on the forehead via a magnetic connection to a self-adhesive electrode, which then sends precise micro-impulses through the skin to the upper branches of the trigeminal nerve to either relieve headache pain during a migraine attack or to prevent a future migraine attack.

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