FDA Approves Flow Neuroscience's At-Home Brain Stimulation Device for Depression Treatment
Flow Neuroscience has received FDA approval for its at-home brain stimulation device, Flow, designed to treat major depressive disorder (MDD). This marks the first time a non-drug therapy for depression can be prescribed for home use in the U.S. The device uses transcranial direct current stimulation (tDCS) to apply a gentle electrical current to the prefrontal cortex, which is often underactive in people with depression. The approval follows a landmark clinical study published in Nature Medicine, demonstrating significant symptom reduction in patients using the device. The study showed that 58% of patients achieved remission by the end of a 10-week period, with the device proving effective even for those already on medication or psychotherapy. Flow's device has been used by over 55,000 people in Europe and is expected to be available in the U.S. by Q2 2026. 
