The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to the Sooma Medical at-home neuromodulation device for the treatment of depression.

The portable, patient-administered Sooma Depression Therapy uses a mild electrical current to stimulate targeted areas of the brain and improve symptoms of depression.

Already approved in the EU, the therapy is claimed to be an effective first-hand treatment option for depression and is used by hundreds of patients in more than 30 countries annually.

The company stated that the Sooma Depression Therapy is painless, does not involve medication and is always prescribed by a medical professional.

The treatment includes a daily 30-minute session for a minimum of three weeks.

Additionally, the device can be used as a stand-alone treatment or together with other treatment types as an add-on therapy, eliminating the risk of drug interactions with pharmaceuticals.

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Sooma Medical CEO Tuomas Neuvonen said: “We are thrilled to receive this breakthrough designation from the FDA. 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 US as quickly as possible.”

According to the company, depression is a serious mental health condition and current treatment options, including psychotherapy and antidepressants, while effective can have limitations.

 The Sooma Depression Therapy provides a non-invasive alternative, which significantly improves the lives of people who are suffering from depression.

The company is dedicated to developing advanced and accessible solutions to improve quality of life for people affected by mental health conditions.