FDA Approves First At-Home Brain Device for Depression

More than 20 million American adults live with depression, and roughly one-third don't find relief from medication or quit due to side effects. Now they have a new option that doesn't require pills or clinic visits.

The FDA just approved the FL-100, a lightweight headset from Flow Neuroscience that patients wear at home for 30 minutes daily. It uses transcranial direct current stimulation (tDCS), which sends a gentle electrical current to the prefrontal cortex, the brain region responsible for mood regulation.

In people with depression, this area often shows reduced activity. The device aims to restore healthier brain signaling over time, similar to how physical therapy helps rebuild muscle strength.

The approval came after a rigorous clinical trial published in Nature Medicine. Patients using the device showed a 58 percent improvement in depression symptoms after 10 weeks, with many noticing changes within three weeks.

Side effects were minimal. Some users experienced mild skin irritation, temporary headaches, or brief tingling sensations where the electrodes touch the scalp, but these effects typically faded quickly.

The device pairs with a mobile app that guides treatment while doctors monitor progress remotely. Clinicians can prescribe it alone or alongside therapy and antidepressants for adults 18 and older with moderate to severe major depressive disorder.

The Ripple Effect

This technology has already helped over 55,000 people across Europe, the UK, and Hong Kong. In Britain, parts of the public health system now prescribe it as standard care.

The US approval signals a broader shift toward personalized, tech-enabled mental health treatment. Just this year, UCLA Health researchers developed another experimental brain-stimulation approach, suggesting at-home neuromodulation may soon become routine rather than experimental.

Flow expects the device to reach US patients in the second quarter of 2026. The company also plans to explore using the platform for sleep disorders, addiction, and traumatic brain injury.

For people who have spent years cycling through medications without relief, having another clinically proven choice represents genuine hope. Insurance coverage details and pricing will be announced as the launch approaches.

For millions who've struggled to find what works, this marks a real turning point in depression care.