FDA Approves First At-Home tDCS Treatment for Major Depressive Disorder
Key Clinical Summary
- The US Food and Drug Administration (FDA) has approved Flow Neuroscience’s FL-100, the first prescription at-home transcranial direct current stimulation (tDCS) device for adults with moderate to severe major depressive disorder (MDD).
- Randomized controlled trial showed 58% remission at 10 weeks, with mild, transient side effects.
- Device may be used as monotherapy or adjunctive therapy; US availability expected in Q2 2026.
The US Food and Drug Administration (FDA) has approved Flow FL-100, the first at-home transcranial direct current stimulation (tDCS) device for the treatment of moderate to severe major depressive disorder (MDD) in adults, announced manufacturer Flow Neuroscience.
The approval marks the first time US clinicians may prescribe a fully remote, non-drug neuromodulation therapy for depression. Evidence supporting the decision includes a large randomized controlled trial published in Nature Medicine.
Efficacy Results and Regulatory Context
The FL-100 headset delivers low-intensity electrical current to the prefrontal cortex, a region often underactive in patients with depression. In a 2024 clinical trial, the device demonstrated significant improvements in depressive symptoms, with reductions appearing as early as 3 weeks. Active tDCS outperformed sham, producing 2–3 times higher remission and response rates. By week 10, 58% of actively treated participants achieved remission. Efficacy was also observed among individuals using the device alongside antidepressants or psychotherapy.
Safety findings indicate mild, transient adverse events, including skin dryness, irritation, redness, headaches, and stinging or burning at the stimulation site. Skin burns have occurred when electrode pads were reused or allowed to dry out.
No boxed warning is associated with the device, which is indicated for use, either as monotherapy or as an adjunctive treatment, in patients aged 18 and older with MDD in the current episode who are not considered treatment resistant to medication.
Clinical Implications
The FL-100 introduces a novel treatment option for patients seeking non-pharmacologic care or adjunctive therapy for moderate to severe MDD. At-home delivery may help reduce access barriers, particularly for patients who discontinue medications due to intolerable adverse effects or incomplete response. The device’s compatibility with antidepressants and psychotherapy may also expand its applicability in integrated care models.
Expert Commentary
Flow's Chief Medical Officer Dr Kultar Garbha emphasized that data from more than 55,000 users in Europe, the UK, Switzerland, and Hong Kong further support the device’s efficacy. “Among our real-world users, 77% see improvements in as little as 3 weeks,” Dr Garcha said in a news release. “Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care.”
Flow expects US availability by mid-2026, with plans to expand research into additional neuropsychiatric conditions.
