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FDA Approves First At-Home Device for Depression Treatment

12/11/2025

Summary

Story summary

Flow Neuroscience's FL-100 headset received approval from the U.S. Food and Drug Administration for at-home treatment of major depressive disorder, the first device of its kind cleared for sale in United States.
The device requires a prescription and is planned to launch in United States in Q2 2026.
FDA approval followed studies showing significant symptom improvement, and Flow Neuroscience plans to negotiate insurance coverage and has raised $22 million.

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Story summary

Flow Neuroscience's FL-100 headset received approval from the U.S. Food and Drug Administration for at-home treatment of major depressive disorder, the first device of its kind cleared for sale in United States.
The device requires a prescription and is planned to launch in United States in Q2 2026.
FDA approval followed studies showing significant symptom improvement, and Flow Neuroscience plans to negotiate insurance coverage and has raised $22 million.