May 29, 2020 | Neuronetics, Inc., the Malvern, PA manufacturer of neuromodulation systems to treat psychiatric disorders, announced that the FDA has 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 patients and healthcare providers 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 submitted initial clinical plans for discussion with the FDA.
With the Breakthrough Device Designation, NeuroStar could potentially provide more effective treatment with limited safety concerns to this additional patient population.
