Sam Brusco, Associate Editor03.10.23
Finland-based company Sooma Medical has gained Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its portable, patient-administered neuromodulation device to treat depression.
The treatment uses a mild electrical current to stimulate target areas of the brain to improve depressive symptoms. The treatment consists of daily, 30-minute treatment sessions for a minimum of three weeks.
It can be used as standalone treatment or add-on therapy with pharmaceutical treatment.
"We are thrilled to receive this breakthrough designation from the FDA," Tuomas Neuvonen, CEO of Sooma told the press. "This is a huge step forward for our company and, more importantly, for the millions of people suffering from depression. We are committed to making this innovative treatment accessible to patients in the U.S. as quickly as possible."
Current treatment options for depression—such as antidepressants and psychotherapy—can be effective but have some limitations. Sooma Depression Therapy is a new, non-invasive alternative that could significantly improve the lives of those suffering from depression.
Sooma Depression Therapy is already approved in the EU and is used by hundreds of patients annually in over 30 countries. Sooma is continuing to work closely with the FDA to bring this treatment to market.
The treatment uses a mild electrical current to stimulate target areas of the brain to improve depressive symptoms. The treatment consists of daily, 30-minute treatment sessions for a minimum of three weeks.
It can be used as standalone treatment or add-on therapy with pharmaceutical treatment.
"We are thrilled to receive this breakthrough designation from the FDA," Tuomas Neuvonen, CEO of Sooma told the press. "This is a huge step forward for our company and, more importantly, for the millions of people suffering from depression. We are committed to making this innovative treatment accessible to patients in the U.S. as quickly as possible."
Current treatment options for depression—such as antidepressants and psychotherapy—can be effective but have some limitations. Sooma Depression Therapy is a new, non-invasive alternative that could significantly improve the lives of those suffering from depression.
Sooma Depression Therapy is already approved in the EU and is used by hundreds of patients annually in over 30 countries. Sooma is continuing to work closely with the FDA to bring this treatment to market.