FDA grants breakthrough device designation for at-home depression treatment

The FDA has granted breakthrough device designation to a Finnish medical company for its portable, patient-administered neuromodulation device to treat depression.

According to a release issued by Sooma Medical, which provides brain stimulants for psychiatric and neurological disorders, the device employs a mild electrical current to stimulate targeted brain areas, resulting in improvement of depressive symptoms. The breakthrough designation provides a chance for Sooma Depression Therapy to become more readily available as a new treatment option for those in the United States dealing with major depressive disorder.

“We are thrilled to receive this breakthrough designation from the FDA,” Sooma CEO Tuomas Neuvonen said in the release. “Twenty-one million people worldwide are estimated to suffer at least one major depressive episode in their lives. We are committed to making this innovative treatment accessible to patients in the U.S. as quickly as possible.”

According to statistics from WHO cited in the release, depression affects approximately 264 million people of all ages across the globe, specifically young adults aged 18 to 25 years, carrying an estimated treatment cost of $1 trillion per year.

Sooma described the therapy as “painless.” According to the release, it involves no medication and is prescribed by a medical professional.

The treatment itself consists of daily 30-minute sessions and lasts a minimum of 3 weeks, according to the release. The therapy can be employed both as a standalone treatment or as an add-on to prescribed pharmaceuticals.