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Flow is a transcranial direct current stimulation device that delivers low-intensity direct electrical current to specific areas of the brain through electrodes that are placed on the scalp.

Flow Neuroscience has secured FDA approval for its at-home brain stimulation device, the FL-100 wearable device, as a ...

FRIDAY, Dec. 12, 2025 (HealthDay News) — An at-home device that sends a gentle electrical current to the brain to help treat depression has been cleared by the U.S. Food and Drug Administration (FDA).

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Patients can use the headset themselves in their homes to counteract moderate to severe depression, with what the FDA says are “modest” results.

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The US Food and Drug Administration (FDA) has cleared Flow Neuroscience’s at-home, non-drug depression treatment, making it the first device of its kind to gain clearance from the agency.