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FDA Clears Flow Neuroscience At-Home Depression Wearable

By Drooid · Sep 15, 2026, 2:15 PM UTC · How we work

Summary

Story summary

Swedish firm Flow Neuroscience received FDA approval for its at-home depression wearable in the United States.
The headset delivers low-intensity electrical stimulation to the left frontal lobe.
Patients wear the device on the forehead for 30 minutes daily, controlled via a smartphone app.
FDA clearance arrived in December 2025, adding the device to a new class of brain-stimulating wearables.
The headset costs in the four-figure range, which may limit rapid patient adoption.

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Story summary

Swedish firm Flow Neuroscience received FDA approval for its at-home depression wearable in the United States.
The headset delivers low-intensity electrical stimulation to the left frontal lobe.
Patients wear the device on the forehead for 30 minutes daily, controlled via a smartphone app.
FDA clearance arrived in December 2025, adding the device to a new class of brain-stimulating wearables.
The headset costs in the four-figure range, which may limit rapid patient adoption.