The brief
- FDA approval on 8 December 2025 for the FL-100 device as the first at-home tDCS system for depression treatment.
- Pivotal trial showed 57.5% remission rate at 10 weeks versus sham control across 174 patients using 2 mA current for 30-minute sessions.
- US commercial launch began September 2026 as a prescription-only treatment.
Technical approach
tDCS technology
Transcranial current stimulation
Mild electrical current through scalp electrodes targets the dorsolateral prefrontal cortex.
Safety profile
Well-tolerated, minimal side effects
Non-invasive technique with transient skin reactions and mild tingling.
