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FDA Clears At-Home Brain Stimulation Device for Depression
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Fusion42 · 22 July 2026 · Fusion42 review
The FDA cleared Flow Neuroscience's FL-100, an at-home transcranial direct current stimulation headset for depression, following a remote clinical trial showing 45% remission rates versus 22% in controls. The device becomes available in the US on 1 September 2026 and can be used standalone or alongside antidepressants and psychotherapy.
This Wire brief sits within Fusion42's coverage of Digital Health.
◆ ◆ The Wire takeaway
You can now sell a prescription medical device for depression without a clinic visit. The FDA has accepted that safety and efficacy don't require in-person supervision, which opens the entire telehealth mental health stack to neuromodulation—and means every telehealth operator needs to decide whether to build, partner, or be displaced by hardware-enabled competitors.
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1 source · 22 Jul 2026
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