In December 2025, the US Food and Drug Administration approved Flow Neuroscience's FL-100 headset.
It is the first non-drug brain-stimulation device cleared for adults to use at home for moderate to severe major depression.
The company plans a US launch in the second quarter of 2026. The device will be available by prescription only.
The FL-100 delivers transcranial direct current stimulation, or tDCS.
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A mild electrical current is sent through the scalp to activate a mood-regulating region called the dorsolateral prefrontal cortex.
A companion smartphone app guides the sessions.
How the treatment works
The approved protocol runs for 10 weeks.
Patients complete five 30-minute sessions per week for the first three weeks, then three sessions per week for the remaining seven.
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A mental health clinician prescribes the device, and the app supports adherence between visits.
The FDA cleared the FL-100 for adults with moderate to severe major depressive disorder.
It is not authorized for treatment-resistant depression, adolescent depression, anxious depression or obsessive-compulsive disorder.
What the clinical trial showed
Approval was supported by a randomized trial of 174 adults with moderate-to-severe depression, published in Nature Medicine.
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Over 10 weeks, participants using active stimulation saw scores on the Hamilton Depression Rating Scale fall by 9.41 points, versus 7.14 points in the sham group.
At the 10-week mark, 44.9 percent of the active group met the criteria for remission, compared with 21.8 percent of the sham group.
Reported side effects were mostly mild.
The most common were skin redness and irritation under the electrodes, along with occasional headaches.
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Two participants developed burns at the electrode site.
Who could benefit and what it may cost
Major depression is one of the most common mental disorders in the country.
The National Institute of Mental Health estimates that about 21 million US adults had at least one major depressive episode in 2021, roughly 8.3 percent of the adult population.
Flow's headset has already been used by more than 55,000 people in Europe, the UK, Switzerland and Hong Kong.
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It is available directly to consumers there or through the National Health Service.
In the UK the device retails at £399, about $535, and can also be rented for £79 per month. US pricing has not been finalized.
The FL-100 is not intended to replace clinic-based options such as transcranial magnetic stimulation for treatment-resistant patients.
Anyone considering the headset should discuss it with a physician, since it is prescription only and not suitable for every form of depression.
Flow Neuroscience says the FL-100 will be available to US patients through prescribing clinicians in the second quarter of 2026.
This article is made and published by Ida-Marie Palm Varbæk, who may have used AI in the preparation.