Finland-based Sooma Medical has received the US Food and Drug Administration (FDA) Breakthrough Device designation for its portable, at-home neuromodulation device to treat depression.

Sooma Depression Therapy uses a mild electrical current to stimulate targeted areas on the brain to improve the symptoms of depression.

The US health regulator grants breakthrough designation for novel devices that show promise in improving existing options for severe or life-threatening conditions.

According to the Finnish medical device company, Sooma Depression Therapy is already approved in the EU and was used by hundreds of patients in more than 30 countries.

It is an effective first-hand treatment option for depression, which is painless, involves no medication, and is always prescribed by a medical professional, said the company.

Sooma 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.”

Depression is a serious mental health condition, and current treatment options, including antidepressants and psychotherapy, can be effective but also have limitations.

The company claimed that its Sooma Depression Therapy offers a non-invasive alternative that significantly improves the lives of those suffering from depression.

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

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

According to Sooma’s post-market data, more than half of patients achieve more than 50% improvement in their depressive symptoms after the treatment.

Sooma Medical is dedicated to developing advanced and accessible solutions to improve people’s lives affected by mental health conditions.

The company said it continues to work closely with the FDA to bring this treatment to the market and make it available to more patients as soon as possible.