Empower: tDCS for Major Depressive Disorder at Home — Phase 2 RCT (NCT05202119) — Completed, FDA PMA approved

Preview

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…