Empower: tDCS for Major Depressive Disorder at Home — Phase 2 RCT (NCT05202119) — Completed, FDA PMA approved
Summary
Flow Neuroscience's completed Phase 2 RCT (NCT05202119) that formed the basis for the December 11, 2025 FDA PMA approval of FL-100. The double-blind, placebo-controlled, randomized superiority trial evaluated at-home tDCS (2mA, 30 min/day, 3-5x/week, 10 weeks) for moderate to severe MDD. Results: 58% remission in active arm. PMA application number P230024. The first FDA PMA approval for an at-home brain stimulation device for depression in the United States. Available via prescription in the US from Q2 2026 at $500-800 retail.
Why it matters
NCT05202119 is one of the most commercially consequential completed neurotech clinical trials in history — a single Phase 2 study that convinced FDA to grant PMA (the highest device approval standard) for the first at-home prescription brain stimulation therapy for depression. The trial's fully remote design, 58% remission rate, and mild side effect profile are the commercial foundation for Flow Neuroscience's US market entry.
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