FDA Clears First At-Home Brain Stimulation Device for Depression

Key facts

• The US Food and Drug Administration has cleared the FL-100 headset developed by Flow Neuroscience for home treatment of moderate to severe depression.
• The device delivers transcranial direct current stimulation to the dorsolateral prefrontal cortex, a brain region linked to mood regulation.
• Clinical trials involving 174 adults showed significant symptom reduction, with over half achieving remission; side effects were limited to mild headaches and skin irritation.
• Flow Neuroscience estimates the device will cost between 500 and 800 US dollars with no subscription or maintenance fees.