Cerena Transcranial Magnetic Stimulator is FDA approved to treat Migraine-eNeura Therapeutics
The FDA allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), from eNeura Therapeutics, the first device to relieve pain caused by Migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack. The FDA reviewed the data for the Cerena TMS through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
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