FDA Grants NeuroStar® Advanced Therapy System Breakthrough Device Designation To Treat Bipolar Depression

Neuronetics, Inc., a commercial stage medical technology company, announced that the U.S. Food and Drug Administration (FDA) has recently granted Breakthrough Device Designation for the Company’s NeuroStar Advanced Therapy System for the treatment of bipolar depression. The FDA’s Breakthrough Device Program is intended to help consumers and health care professionals receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program creates an expedited pathway for prioritized FDA review of the NeuroStar Advanced Therapy clinical trial program. Neuronetics has . . .