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FDA Approves Flow Neuroscience Device for Depression Treatment

1/21/2026

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Summary

Story summary

The U.S. Food and Drug Administration approved Flow Neuroscience FL-100, a prescription home-use device for adults with moderate to severe depression.
Flow Neuroscience developed the FL-100, which uses transcranial direct current stimulation (tDCS) to enhance prefrontal signaling.
Clinical trials show a 58% average improvement after 10 weeks.
The United States will see FL-100 availability by mid-2026, and a prescription will be required.

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Story summary

The U.S. Food and Drug Administration approved Flow Neuroscience FL-100, a prescription home-use device for adults with moderate to severe depression.
Flow Neuroscience developed the FL-100, which uses transcranial direct current stimulation (tDCS) to enhance prefrontal signaling.
Clinical trials show a 58% average improvement after 10 weeks.
The United States will see FL-100 availability by mid-2026, and a prescription will be required.