FDA Breakthrough Device Designation granted to Sooma for Its Innovative At-Home Depression Treatment Device

Sooma Depression Therapy could become available as a new treatment option sooner for people affected by Major Depressive Disorder (MDD) in the United States under this expedited process.

We are proud to announce the U.S. Food and Drug Administration (FDA) has granted Sooma Breakthrough Device Designation for our portable, patient-administered neuromodulation device to treat depression.

The FDA’s breakthrough designation is reserved for novel therapies that show significant potential to provide a substantial improvement over existing options for severe or life-threatening conditions. 

Sooma Medical’s device utilises a mild electrical current to stimulate targeted brain areas resulting in a significant improvement in depressive symptoms. With this Breakthrough Device Designation, the device could become available as a new treatment option sooner for people affected by Major Depressive Disorder (MDD) in the United States. 

“We are thrilled to receive this breakthrough designation from the FDA,” said Tuomas Neuvonen, CEO of Sooma. “Annually, 21 million people in the U.S. are estimated to suffer at least one major depressive episode. 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 U.S. as quickly as possible,” he concluded. 

Closing the mental health gap

According to the WHO, depression is one of the leading causes of disability worldwide, affecting approximately 264 million people of all ages, but more often young adults aged 18-25. It is estimated that the cost of this disease is $1 trillion (USD) per year.

Current treatment options against depression, such as antidepressants and psychotherapy, can be effective but also have limitations. Sooma Depression Therapy has the potential to significantly improve the lives of those suffering from depression with a flexible treatment option for those underserved by medication or with limited access to psychotherapy by providing easy, accessible, and affordable treatment.

Sooma Depression Therapy is an effective first-hand treatment option for depression used by thousands of patients annually in more than 30 countries. The therapy is painless, involves no medication, and is always prescribed by a medical professional. 

The treatment consists of daily 30-minute sessions and lasts a minimum of three weeks. It can also be used as a stand-alone treatment or as an add-on therapy along with other types of treatment, such as pharmaceuticals, without the risk of dangerous drug interactions.

Most patients feel relief from their depressive symptoms around the third week of treatment. According to our post-market data, more than half of patients achieve a complete clinical response, meaning a 50% or greater improvement in their depressive symptoms after the treatment. 

At Sooma, we are dedicated to developing innovative, accessible solutions to improve the lives of those affected by mental health conditions. We will continue to work closely with FDA to bring this treatment into the U.S. market and to make it available to patients as soon as possible.


About Sooma:

Established in 2013, Sooma Oy is a Finnish medical device company and the market leader in Transcranial Direct Current Stimulation (tDCS) in clinical use. Sooma therapies are offered by over 150 medical centres across 35 countries, with over 15,000 patients treated.


TDCS is the treatment method offered by Sooma for depression (Sooma Depression Therapy, indicated for Major Depressive Disorder) and chronic pain (Sooma Pain Therapy, indicated for Fibromyalgia and chronic neuropathic pain). By using Sooma devices, you ensure that you are performing a safe and effective patient treatment, should it be in the hospital or at patients’ homes, with legal, regulated, tested, and effective equipment that complies with the latest EU regulations and features all the recommended elements listed on this article.

Do you want to hear more about Sooma Depression or Pain Therapies? Our dedicated team will answer any questions you may have, and if you wish to proceed, they will help you get started with Sooma Therapy at your clinic or hospital!

Contact our team here.


Read more