Flow Neuroscience announced FDA approval of its Flow at-home brain-stimulation device for treating major depressive disorder, marking the first time American clinicians can prescribe a novel at-home non-drug therapy as both a stand-alone and adjunctive treatment for adults with moderate to severe depression. Depression currently affects more than 20 million U.S. adults, a 60% increase over the last decade. Around a third of patients are not responsive to antidepressants, and many stop treatment because of side effects such as sexual dysfunction, weight gain, emotional blunting, and others.
Clinical Evidence and Results
The device uses transcranial direct current stimulation (tDCS), a technology backed by more than 9,000 publications and over 25 years of clinical research. 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. Flow’s landmark randomized controlled clinical study, published in Nature Medicine, showed that patients using the FL-100 device experienced symptom reductions as early as within 3 weeks. The largest clinical trial of its kind demonstrated that active tDCS treatment outperformed sham stimulation, achieving two to three times higher remission and response rates, with 58% of patients in remission by the end of the 10-week study. Results were also observed among patients already on medication or psychotherapy who used FL-100 adjunctively. Among Flow’s real-world users, 77% see improvements in as little as three weeks, according to Chief Medical Officer Dr. Kultar Garcha.
Accessibility and Global Rollout
Flow has been used by more than 55,000 people in the EU, UK, Switzerland, and Hong Kong. In the UK, it is used by multiple NHS trusts and is prescribed by doctors in the public health system. The device received Breakthrough Device Designation from the FDA in 2022, a program for technologies offering potentially more effective treatment for debilitating diseases. Flow expects the device to be available in the U.S. as early as Q2 2026 and is planning to evaluate its platform for additional neuropsychiatric indications, including traumatic brain injury, addiction, and sleep disorders.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://med-techinsights.com/2025/12/11/fda-approves-world-first-brain-stimulation-device-for-depression/