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The U.S. Food and Drug Administration (FDA) has approved the first at-home brain stimulation device for treating depression. Developed by Flow Neuroscience, the FL-100 device delivers a gentle electrical current to the brain's dorsolateral prefrontal cortex, a region associated with mood regulation. This device is designed for adults aged 18 and older with moderate to severe major depressive disorders. It can be used as a standalone treatment or alongside other therapies.
The FDA's approval was based on the Empower phase 2 study, which showed that 58% of participants achieved remission of their depression after 10 weeks of using the device. Globally, 77% of users reported improvement within three weeks. The device has already been used by over 55,000 patients in Europe, the UK, Switzerland, and Hong Kong.
The FL-100 device is worn as a headset and provides transcranial direct current stimulation (tDCS). A typical treatment course lasts 12 weeks, starting with five sessions per week and tapering to two or three sessions weekly. Each session lasts 30 minutes. The device is guided by a digital app or can be used under clinician supervision. Side effects are generally mild, including skin irritation and headaches.
Flow Neuroscience plans to launch the device in the U.S. in the second quarter of 2026, with an estimated retail price between $500 and $800. Insurance coverage details will be announced early in 2026. The device's approval marks a significant step in non-drug treatments for depression, offering a new option for those who may not respond to traditional medications.
