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Sooma receives FDA Breakthrough Device designation for depression therapy device

Finnish company Sooma Medical has received Breakthrough Device designation by the FDA for its portable, at-home neuromodulation device to treat depression.
Sooma Depression Therapy is a painless, medication-free, prescribed device, which uses a mild electrical current to stimulate targeted areas of the brain. It involves daily 30-minute sessions over a minimum of a three-week period and has been proven to provide “significant improvement” for patients with Major Depressive Disorder (MDD), according to Sooma.
Current treatments for MDD, such as antidepressants and psychotherapy, can be effective, but limitations and medication side effects make it difficult for patients to engage with them on a long-term basis. Sooma Depression Therapy can be used as a stand-alone treatment or in conjunction with medication, and as it is pharmaceutical-free there is no risk of drug interactions, which can be dangerous.
According to Sooma’s post-market data, over half of patients felt they achieved a complete clinical response, meaning a 50% or higher improvement in their depressive symptoms.
Sooma CEO Tuomas Neuvonen commented: “We are thrilled to receive this Breakthrough designation from the FDA. 21 million people worldwide are estimated to suffer at least one major depressive episode in their lives. This designation recognises that our device is a perfect solution, enabling a fast, effective and affordable treatment on a greater scale. We are committed to making this innovative treatment accessible to patients in the US as quickly as possible.”