Medtech maker eNeura Therapeutics won FDA clearance to market its 1st-of-its-kind Cerena transcranial magnetic stimulator, landing regulatory approval through the agency’s less-stringent de novo premarket review pathway.
The Cerena TMS is now the 1st available device to relieve migraine headache pain caused by auras, eNeura said.
The Cerena TMS devices uses magnetic energy to help relieve pain associated with migraines, stimulating the occipital cortex in the brain via a prescription device that patients hold against the back of the head after the onset of pain.
Clearance was granted based on data collected from a randomized, controlled clinical trial of 201 patients who had mostly moderate to strong migraine headaches.
“Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” FDA Center for Devices & Radiological Health Office of Device Evaluation director Christy Foreman said in prepared remarks.
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