Flow Neuroscience FL-100 becomes first FDA-approved at-home brain stimulation for depression — December 11, 2025
Summary
The FDA approved Flow Neuroscience's FL-100 transcranial direct current stimulation (tDCS) device on December 11, 2025, making it the first at-home, prescription neuromodulation therapy authorized in the United States for adults with moderate to severe major depressive disorder. The decision was based on the Empower Phase 2 RCT (NCT05202119): 58% of patients achieved depression remission after a 10-week treatment course, with meaningful reductions in clinician-rated and patient-reported depression scales. The FL-100 headset delivers 2mA of direct current to the left dorsolateral prefrontal cortex for 30 minutes per day, 3-5 times per week, with a companion smartphone app for session monitoring and clinician dashboard for oversight. US availability was announced for Q2 2026, with retail price estimated at $500-800. Flow already helped over 55,000 people in Europe before US approval. CEO Erin Lee: "Flow's FDA approval is a watershed moment for the treatment of depression: the first step in moving from pharmaceutical treatments to tech-based therapies with minimal side effects."
Why it matters
Flow Neuroscience's FL-100 is the first FDA PMA-approved at-home brain stimulation device for depression in the United States — a milestone covered by the New York Times, IEEE Spectrum, Psychiatric Times, and Neurology Advisor. The 58% remission rate from the Empower RCT compares favorably to antidepressant medication (approximately 30-40% remission), and the prescription-only home delivery model provides access for the 20+ million US depression patients without requiring clinic visits. This approval will likely trigger insurance coverage negotiations that could bring the device price below $500 for insured patients.
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