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FDA approves 1st home-use headset to treat depression
short by Mansi Agarwal / on Thursday, 11 December, 2025
The US Food and Drug Administration (FDA) has approved a home-use headset to treat major depressive disorder, making it the first such device to be approved in the US. Called FL-100, the headset sends a gentle electrical current to the part of the brain that regulates mood. Patients will need a prescription to use the headset.
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