FDA Approves First At-Home Brain Stimulation Device for Depression Treatment
WASHINGTON, D.C. — For the first time, adults suffering from moderate to severe depression will have access to a prescription brain stimulation device designed for use at home, following a landmark approval by the U.S. Food and Drug Administration. The device, called the FL-100 and developed by Flow Neuroscience, represents a significant shift in mental health treatment by allowing patients to receive non-invasive brain stimulation outside of clinical settings.
Depression affects more than 20 million adults in the United States, and many do not find adequate relief from traditional antidepressant medications or discontinue their use due to side effects. The FL-100 headset uses transcranial direct current stimulation (tDCS), a method that delivers a gentle electrical current to the prefrontal cortex, a brain region closely linked to mood regulation and stress response. By stimulating this area, the device aims to restore healthier brain activity patterns that are often diminished in people with depression.
The lightweight headset pairs with a mobile application, enabling patients to undergo approximately 30 minutes of stimulation daily within the comfort of their own homes. Importantly, clinicians can monitor treatment progress remotely, ensuring medical oversight throughout the therapy. This approach may increase access to effective treatment, especially for those who face barriers to frequent in-person care.
The FDA’s decision was based on a randomized controlled trial demonstrating that participants who received active stimulation experienced meaningful improvements in both clinician-rated and self-reported measures of depression. The device is intended for adults 18 years and older and can be prescribed as a stand-alone therapy or alongside antidepressants and psychotherapy.
Flow Neuroscience’s FL-100 is expected to become available to patients in 2026, marking a new era in digital therapeutics for mental health. The FDA’s approval aligns with growing interest in innovative, technology-driven solutions to address the widespread burden of depression.
For more information on the FDA’s regulatory process and mental health device approvals, visit the FDA’s official website. Details on depression prevalence and treatment options can be found through the National Institute of Mental Health. The technology behind tDCS and its clinical applications are further explained by the National Institute of Neurological Disorders and Stroke. Patients and providers seeking guidance on digital health tools may consult resources from the Office of the National Coordinator for Health Information Technology.
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