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Flow FL-100 launches in US Q2 2026 — first at-home prescription tDCS device available to patients via clinician prescription

New York Times / Patient Care Online4/1/2026·04/01/26🌐 Europe

Summary

Flow Neuroscience announced that its FDA-approved FL-100 at-home tDCS device for depression is available to US patients in Q2 2026, available via clinician prescription for people aged 18+ with moderate to severe MDD, either as standalone or adjunctive therapy. The device is priced at $500-800 retail; insurance coverage details are being announced in early 2026. The company intends to study the FL-100 platform for additional indications including traumatic brain injury, addiction, and sleep disorders. Flow previously received FDA Breakthrough Device Designation in 2022. Coverage in the New York Times described Flow as the "first at-home brain stimulation device for major depression."

Why it matters

The US commercial launch of FL-100 in Q2 2026 makes Flow Neuroscience the first company to commercially sell at-home prescription brain stimulation for depression in the largest healthcare market in the world. Their pipeline expansion into TBI, addiction, and sleep disorders using the same hardware creates a multi-indication platform commercial opportunity from a single FDA-cleared device.

#tDCS#Depression#Mental Health Tech#FDA#Non-invasive#USA

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