In Case You Haven't Heard…

Flow Neuroscience announced U.S. Food and Drug Administration (FDA) approval of their breakthrough Flow at‐home brain‐stimulation device for the treatment of major depressive disorder, a news release stated. FDA approval marks the first time in history American clinicians are able to prescribe a novel at‐home non‐drug therapy as both a stand‐alone and an adjunctive treatment for adults with moderate to severe depression, Flow Neuroscience officials stated. Transcranial direct current stimulation (tDCS), the technology behind Flow, is backed by more than 9,000 publications and over 25 years of clinical research in depression treatment, stroke recovery, pain management, and other use‐cases, according to officials. Flow's neurostimulation device applies a gentle electrical current to the prefrontal cortex, the part of the brain involved in mood regulation and stress response, which is often underactive in people with depression. To prove device effectiveness, Flow published their landmark randomized controlled clinical study in Nature Medicine , showing that patients using Flow's FL‐100 tDCS device experienced symptom reductions as early as within three weeks. These results revealed a clinically meaningful response to treatment, and side effects were, in general, mild and transient. Flow has been used by more than 55,000 people in Europe, the United Kingdom, Switzerland, and Hong Kong. Flow expects the device to be available in the United States as early as Q2 2026.