Flow Neuroscience Announces FDA Approval of World's First At-Home Brain Stimulation Treatment for Depression
Summary
Flow Neuroscience announced FDA approval of its FL-100 transcranial direct current stimulation system, making it the first at-home, prescription neuromodulation therapy authorized in the United States for adults with moderate to severe major depressive disorder. The device delivers low-intensity electrical stimulation to the prefrontal cortex and can be prescribed as standalone or adjunctive treatment. Over 55,000 people have already used the system in Europe, the UK, Switzerland, and Hong Kong.
Why it matters
This approval represents a watershed moment for mental health treatment, creating the first FDA-approved tech-based at-home alternative to pharmaceutical interventions for depression. With over 20 million U.S. adults living with depression and approximately one-third not responding adequately to antidepressants, Flow's non-drug approach with minimal side effects could fundamentally expand access to effective depression care.
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