StoryRegulatory
FDA approves Flow Neuroscience FL-100 as first at-home brain stimulation device for depression
Flow Neuroscience received FDA premarket approval on 8 December 2025 for the FL-100, a transcranial direct current stimulation headset for at-home treatment of major depressive disorder. The pivotal trial enrolled 174 adults with moderate-to-severe depression and found that 57.5% achieved clinical remission at 10 weeks using the active device, compared to approximately 19% with sham stimulation, with side effects limited to transient skin reactions.
- First FDA premarket approval for at-home tDCS for depression, enabling prescription-based treatment outside clinical settings
- 57.5% clinical remission rate vs sham control in 174-patient double-blind trial using 2 mA current for 30-minute sessions over 10 weeks
- Published in Nature Medicine (2024), the trial was conducted across sites in the UK and US
- Device targets the left dorsolateral prefrontal cortex with remote monitoring and behavioral therapy support via mobile app