From SOOMA: Complete Post through this link…
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.
