US: FDA Approves First At-Home Brain-Stimulation Device for Depression | Firstpost America | N18G

The US FDA has approved the nation’s first at-home brain-stimulation device for depression, marking a major shift in mental-health treatment. Developed by Sweden’s Flow Neuroscience, the headset uses transcranial direct current stimulation to target the brain’s mood-regulating region and offers a drug-free alternative for adults with moderate to severe depression. The decision follows clinical trials showing a 58% remission rate after 10 weeks, with a larger 2024 study confirming significant improvement compared with a control group. Despite some scientific debate, the FDA says the device’s modest benefits outweigh risks such as mild headaches and skin irritation. The approval comes as US depression rates surge, up 60% in a decade and affecting more than 20 million adults annually.

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