Soterix Medical has received CE mark approval for its 1x1 tDCS therapy system to treat Major Depressive Disorder (MDD).
The 1×1 tDCS therapy system is a non-invasive and non-systemic therapeutic device, which provides low-intensity direct current to a region of the cerebral cortex, the part of the brain that controls mood.
The system regulates nerve cells in an area of the brain that were linked to depression by delivering low-intensity current fields.
According to the company, it is a better therapy for adults living with MDD without the systemic side effects commonly associated with oral antidepressant medications.
Soterix Medical Europe business vice-president Shani San Solo said: "The CE mark for 1×1 tDCS therapy system is an important milestone as it signifies that we have met the requirements of the European Union (EU) authorities with extensive clinical efficacy and safety evidence to support the role of 1×1 tDCS in treating depression.
"This announcement also allows commercialization of the 1×1 tDCS system in countries in Asia and Latin America that recognize the CE mark."
The approval was based on data from four studies, which showed the safety and efficacy of 1×1 tDCS therapy in depressed patients across a wide range of antidepressant treatment resistance.