FDA Clears First At‑Home Brain‑Stimulation Device for Depression
The Food and Drug Administration has cleared Flow Neuroscience’s FL-100, the first prescription at-home brain‑stimulation device for adults 18 and older with moderate to severe major depressive disorder. The headset uses transcranial direct current stimulation to deliver low‑level electrical current to the prefrontal cortex for about 30 minutes a day, paired with a mobile app and remote clinician monitoring. FDA’s decision relied on a randomized controlled trial, published in Nature Medicine, in which patients receiving active stimulation showed an average 58% improvement in depression symptoms after 10 weeks compared with controls, with many seeing benefits within three weeks. Reported side effects were generally mild, including temporary skin irritation, redness and headaches. Flow says more than 55,000 people have already used the device in Europe, the U.K., Switzerland and Hong Kong, and it expects to make FL‑100 available to U.S. patients by the second quarter of 2026 as a stand‑alone or adjunct treatment alongside antidepressants and therapy.
📌 Key Facts
- FDA has cleared the FL-100, the first prescription at‑home brain‑stimulation device for major depressive disorder in U.S. adults.
- The device uses transcranial direct current stimulation on the prefrontal cortex for 30 minutes per day under remote clinician supervision.
- In a randomized controlled trial published in Nature Medicine, patients receiving active stimulation had an average 58% symptom improvement after 10 weeks versus controls.
- More than 55,000 people have used Flow’s device in Europe, the U.K., Switzerland and Hong Kong; U.S. availability is expected in Q2 2026.
- Common side effects were mild and short‑term, including skin irritation, redness, headaches and brief stinging at electrode sites.
📊 Relevant Data
The prevalence of major depressive episodes among U.S. adults is highest among those reporting multiple races at 13.9%, compared to 8.1% overall, 8.9% for White adults, 7.5% for Black adults, 7.0% for Hispanic adults, and 5.6% for Asian adults.
Major Depression — National Institute of Mental Health (NIMH)
Among U.S. adults with any mental illness, 58% of White adults receive mental health services, compared to 44% of Hispanic adults, 39% of Black adults, and 33% of Asian adults.
Key Data on Health and Health Care by Race and Ethnicity — KFF
The lifetime prevalence of depression is 36.7% among U.S. women compared to 20.4% among men, with higher rates reported among Black, Hispanic, and Asian American women compared to their male counterparts.
Depression in women — Mental Health America
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