Marom Bikson, André R. Brunoni, Mark S. George
On Dec 8, 2025, the US Food and Drug Administration (FDA) approved the Flow Neuroscience transcranial Direct Current Stimulation (tDCS) device for the treatment of "moderate to severe major depressive disorder (MDD) in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication." This represents the first FDA premarket approval (PMA) for a home-use non-invasive brain-stimulation device specifically indicated for depression treatment. This is a major regulatory milestone in non-pharmacological treatment of depression, and paves the way for additional uses and new technologies of home-based neuromodulation.