Flow Neuroscience Introduces Brain Stimulation Headset for Depression Treatment

Flow Neuroscience today introduced to the U.S. market the first U.S. Food and Drug Administration (FDA)-approved at-home transcranial direct current stimulation (tDCS) treatment for depression.

FL-100 treats moderate to severe major depressive disorder, either as monotherapy or as an adjunctive treatment, in patients ages 18 and older who are not considered treatment-refractory to medication. It is available by prescription only.

The launch gives U.S. clinicians and patients access to a different treatment modality for depression: targeted electrical stimulation that can be delivered at home as part of clinician-supervised care.

Depression remains a major public health challenge in the United States. According to the 2025 National Survey on Drug Use and Health, 19.7 million U.S. adults experienced a major depressive episode in the previous year. The economic burden of major depressive disorder in the U.S. reached an estimated $382.4 billion in 2023 [Greenberg PE et al, 2023].

Existing treatments, including antidepressants and psychotherapy, help many patients but do not meet every need. FL-100 gives clinicians an additional evidence-based treatment option that can be used on its own or alongside medication for eligible patients.

“FDA approval was a major scientific and regulatory milestone for Flow, but making the treatment available to patients is the moment that really matters,” Flow Neuroscience Co-Founder/CEO Daniel Månsson said. “For the first time in the U.S., clinicians can prescribe an FDA-approved tDCS treatment for depression that patients can use in their own homes. It gives patients and clinicians another evidence-based option and a fundamentally different way of approaching depression treatment.”

Bringing Brain Stimulation Treatment Into the Home

Flow Treatment combines the FL-100 Headset with a companion app. The headset applies a gentle electrical current to the left dorsolateral prefrontal cortex—an area of the brain involved in functions including emotion regulation.

Patients follow their prescribed treatment schedule at home; the Flow app guides treatment, tracks changes in symptoms over time, and allows adherence and outcome data to be shared with their clinician.

In Flow’s pivotal clinical trial, 57% of patients achieved remission (MADRS ≤12) at 10 weeks on a treatment protocol of 15 sessions during the first three weeks and three sessions per week thereafter. The study was published in Nature Medicine [Woodham RD et al, 2024].

The U.S. launch follows several years of clinical and real-world use internationally. Flow has now been used by more than 65,000 people globally, with more than 1,200 healthcare professionals prescribing the treatment. In the United Kingdom, Flow is used across multiple NHS organizations and has become part of routine depression care in many services.

“Until now, delivering brain stimulation has typically presented practical barriers to widespread use in routine depression care,” Flow Neuroscience Chief Medical Officer Dr. Kultar Garcha stated. “With Flow, once an appropriate patient has been prescribed treatment, they can follow that treatment at home while their clinician can monitor adherence and outcomes remotely as part of the patient’s comprehensive treatment plan. That creates the opportunity to make an evidence-based form of brain stimulation much easier to incorporate into everyday clinical care.”

To support the U.S. launch, Flow is training clinicians nationwide and establishing simple prescription pathways designed to make FL-100 straightforward to integrate into routine clinical care.

Patients can be evaluated by a clinician in person or through telehealth, including through Flow Care, a telemedicine access pathway delivered by independent licensed healthcare professionals, to determine whether a prescription may be appropriate. Flow also provides training and support to licensed healthcare professionals who wish to evaluate and, where clinically appropriate, prescribe FL-100 for eligible patients.

Founded in Sweden in 2016 by Månsson, a clinical psychologist, and computational neuroscientist Erik Rehn, Flow Neuroscience combines neuroscience, technology, and clinical evidence to develop new approaches to treating mental health conditions. Its first treatment, Flow, combines transcranial direct current stimulation (tDCS) with a companion app to support treatment delivery, symptom tracking, and clinician monitoring.