Sooma Oy Receives FDA Breakthrough Device Designation For At-Home Depression Treatment Device

Sooma Oy (Sooma) a medical device company based in Finland, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its portable, patient-administered neuromodulation device to treat depression. This revolutionary treatment utilizes a mild electrical current to stimulate targeted brain areas, significantly improving depressive symptoms. The FDA's breakthrough designation is reserved for novel therapies that show significant potential to provide a substantial improvement over existing options for severe or life-threatening conditions. The company continues to work closely with the FDA to bring this treatment to the market and to make it . . .