FDA approved tDCS for at-home depression treatment
The U.S. Food and Drug Administration has approved transcranial direct current stimulation (tDCS) for at-home treatment of depression, marking a major milestone for non-invasive brain stimulation. The decision effectively validates tDCS technology for supervised home use and expands depression treatment options beyond traditional medications.
“This is a major milestone for the entire field and an important step toward making non-invasive brain stimulation a more mainstream, accessible option for the millions of depression and chronic pain patients who need new treatment options,” says Andreas Hartlep, CEO of Sooma. “By enabling home use, the FDA’s action lowers barriers to access and reflects rising demand for evidence-based, non-drug treatments.”
In March 2025, Sooma received FDA approval for an Investigational Device Exemption (IDE), and is currently conducting a pivotal U.S. clinical trial of its at-home tDCS device. Sooma previously received FDA Breakthrough Device Designation and is now pursuing full FDA approval.
There is a growing demand for new treatment types in the U.S. Depression is a leading cause of disability on a global scale. It is estimated to affect 8.3% of adults in the U.S., one of the most prevalent psychiatric disorders in the country. Globally, an estimated 12 billion working days are lost every year to depression and anxiety at a cost of $1 trillion per year in lost productivity.
Sooma’s brain stimulation devices have become the most prescribed tDCS therapies worldwide, treating over 30,000 patients and in more than 250 clinics in 35 countries. Sooma has also gained notable industry recognition. In addition to the approval for clinical trial by the FDA, Sooma was also the first device manufacturer to receive EU MDR certification for a tDCS device.
The first FDA approval for at-home tDCS treatment of depression was granted to a device developed by Flow Neuroscience.
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