Sooma Medical, a medical device company based in Finland, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its portable, patient-administered neuromodulation device to treat depression.
This treatment uses 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.
"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.
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.