Sooma Medical Receives FDA Breakthrough Designation

The neuromodulation device has been granted this designation by the FDA for depression treatments.

Image credit: Sooma Medical

Finnish medical device company Sooma Medical has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its portable, patient-administered neuromodulation device to treat depression.

This revolutionary treatment utilizes a mild electrical current to stimulate targeted brain areas, significantly improving depressive symptoms. 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, according to a press release.

"We are thrilled to receive this breakthrough designation from the FDA," said Tuomas Neuvonen, CEO of Sooma. "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 U.S. as quickly as possible."

Depression is a serious mental health condition that affects millions of people worldwide. Current treatment options, such as antidepressants and psychotherapy, can be effective but also have limitations. Sooma Depression Therapy offers a new, non-invasive alternative that has the potential to significantly improve the lives of those suffering from depression.

Read more: DyAnsys Neurostimulation Device Receives FDA Clearance

Sooma Medical is dedicated to developing innovative and accessible solutions to improve the lives of people affected by mental health conditions. The company continues to work closely with the FDA to bring this treatment to the market and to make it available to more patients as soon as possible.

About Sooma Depression Therapy

Sooma Depression Therapy, already approved in the EU, is an effective first-hand treatment option for depression used by hundreds of patients annually in more than 30 countries. The therapy, which is painless and involves no medication, is always prescribed by a medical professional. The treatment consists of daily 30-minute sessions for 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 can feel relief from their depressive symptoms around the third week of treatment. According to Sooma's 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.

About Sooma

Sooma Medical is a Finnish medical device company established in 2013, which works closely with leading experts in psychiatry and clinical neurophysiology to develop effective treatment solutions for health conditions in these areas. Sooma medical devices are engineered and manufactured in Finland following the international ISO 13485 quality management system for medical devices. Devices developed by Sooma have received approvals from international health authorities such as Health Canada, MDA, HSA, TGA, and COFEPRIS. To date, more than 10,000 patients have found relief with these treatments. Sooma Depression Therapy is available in more than 30 countries worldwide.

Sam Draper
March 10, 2023

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