Key Takeaways

The U.S. Food and Drug Administration cleared Flow Neuroscience’s at-home electrical stimulation headset for adults with moderate-to-severe depression

A trial of 174 people found the device led to greater drops in depression

The device will cost about $500 and may become available in the U.S. by mid-2026

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).

Experts say the move could expand access to care for many folks.

The prescription headset, made by Sweden-based Flow Neuroscience , delivers low-level electrical stimulation to a part of the brain involved in mood and stress control. Similar treatments are already used

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