California-based eNeura lands FDA clearance for its Cerena transcranial magnetic stimulator for treatment of migraines, passing through the FDA’s less-stringent de novo review pathway.
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.