News Report | March 24, 2020
FDA Grants NeuroStar TMS Device ‘Breakthrough’ Designation For Bipolar Depression
On March 6, 2020, Neuronetics, Inc. announced that the U.S. Food and Drug Administration (FDA) had recently granted Breakthrough Device Designation for the Company’s NeuroStar® Advanced Therapy System for non-drug treatment of bipolar depression. NeuroStar provides transcranial magnetic stimulation (TMS), a non-invasive form of neuromodulation that uses magnetic pulses to stimulate underactive areas of the brain in those with depression. The NeuroStar device is the first TMS device to receive Breakthrough Device Designation for the study of bipolar depression in adults with Bipolar I or Bipolar II disorders, who have failed to receive satisfactory improvement from . . .