The United States has approved its first at-home brain stimulation device for treating moderate to severe depression, marking a significant shift in how mental health care may be delivered outside traditional clinical settings. The decision clears the FL-100 headset, developed by Flow Neuroscience, for use by adults diagnosed with major depressive disorder under clinician supervision.
Authorization was granted by the U.S. Food and Drug Administration after clinical trial data showed meaningful symptom improvement within weeks. The device uses transcranial direct current stimulation, a non invasive technique that delivers low level electrical currents to the prefrontal cortex, a brain region often underactive in people with depression.
Unlike hospital based neuromodulation therapies, the FL-100 is designed for daily use at home. Patients wear the headset for roughly 20 to 30 minutes per session, following treatment plans remotely monitored by clinicians through a connected mobile app. The system can be used on its own or alongside antidepressant medication and psychotherapy.
The approval follows a randomized controlled trial conducted in a real world home setting. Participants receiving active stimulation experienced an average symptom reduction of about 58 percent on clinician rated depression scales after ten weeks, significantly outperforming the control group. Reported side effects were generally mild and short lived, including headaches and minor skin irritation at electrode sites.
Depression remains one of the most widespread and difficult to treat mental health conditions in the US. More than 21 million adults are affected, and around one third fail to respond adequately to antidepressant drugs or discontinue them due to side effects. That treatment gap has driven interest in alternatives that avoid systemic medication while remaining scalable.
Flow Neuroscience brings prior experience to the US market. The FL-100 has been available in parts of Europe since 2019 and has reportedly been used by tens of thousands of patients across the EU, UK, Switzerland, and Hong Kong. Company data suggests many users see measurable improvement within three weeks, with a majority achieving clinically relevant score reductions.
The FL-100 is expected to reach US patients through clinicians in the second quarter of 2026. Its approval establishes a precedent for regulated, at-home neuromodulation and signals growing acceptance of technology based therapies as a complement or alternative to pharmaceuticals in mental health care.
