Sooma Receives Breakthrough Status for At-Home Depression Treatment Device

Finland-based Sooma Medical has been granted FDA Breakthrough Device status for its portable at-home neuromodulation device to treat depression.

The device uses a non-invasive mild electrical current to stimulate targeted brain areas to improve depressive symptoms.

The treatment, which can be stand-alone or used in combination with drug therapy, consists of daily 30-minute sessions for a minimum of three weeks.

Most patients see results around the third week of treatment, the company said. According to Sooma's post-market data, more than half of patients achieve a complete clinical response in their depressive symptoms after the treatment.

The FDA's breakthrough designation is for novel therapies that show significant potential to provide a substantial improvement over existing options for severe or life-threatening conditions.