The Food and Drug Administration
approved Flow Neuroscience’s at-home brain stimulation device for the treatment of moderate to severe major depressive disorder (MDD).
Why It’s Relevant
Flow uses transcranial direct current stimulation (tDCS) to apply a
gentle electrical current to the part of the brain involved in mood regulation and stress response, typically through scalp electrodes. tDCS has grown in popularity as a noninvasive alternative to traditional depression treatments, in part because of its minimal side effects.
tDCS is currently applied in clinics, but the Flow FL-100 headset can be used at home with remote supervision—potentially making it accessible and convenient for many patients.
By the Numbers
- The evidence supporting the FL-100’s is largely based on Flow Neuroscience's study of 174 participants who were randomized to receive active treatment with the headset or sham stimulation over 10 weeks.
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At the end of the study, 64% of patients in the active group and 32% in the sham group had a clinical response, defined as a 50% reduction in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Similarly, 57% of patients who used Flow met the clinical threshold for remission by the end of the study (defined as a score of 10 or less on the MADRS), compared with 29% in the sham group.
- According to Reuters, Flow Neuroscience expects its device to cost between $500 and $800.
The Other Side
- More than 60% of patients in the active group reported skin redness; skin irritation (7%) and trouble concentrating (14%) were also more common in the active group.
- There were no differences in headache, neck pain, scalp pain, itching, burning, sleepiness, or acute mood changes between the two study groups.
What’s Next
Flow Neuroscience anticipates that the FL-100 headset will be available as a monotherapy or adjunctive treatment via prescription in the spring of 2026. According to Reuters, the company is negotiating with insurance payers and plans to announce coverage partnerships early next year.
The company is also planning to evaluate its technology for other neuropsychiatric issues, including traumatic brain injury, addiction, and sleep disorders.
Related Info
Source
FDA approves world’s first at-home brain stimulation treatment for depression. Flow Neuroscience web page. Published December 11, 2025. flowneuroscience.com/fda-approved-lp-2/
(Image: Flow Neuroscience)