Prescription-only treatment gives clinicians a new way to treat eligible adults with moderate to severe major depressive disorder at home, either as a standalone treatment or alongside medication
Malmö, Sweden
Flow Neuroscience today announced that FL-100 is now available by prescription across the United States, introducing the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for depression to the US market.
FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients aged 18 and older who are not considered treatment refractory to medication. It is available by prescription only.
The launch gives US 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 US adults experienced a major depressive episode in the previous year. The economic burden of major depressive disorder in the US 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. The introduction of 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,” said Daniel Månsson, CEO and co-founder of Flow Neuroscience. “For the first time in the US, 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 the regulation of emotion.
Patients follow their prescribed treatment schedule at home, while 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 3 weeks and 3 sessions per week thereafter. The study was published in Nature Medicine [Woodham RD et al, 2024].
The US 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 UK, Flow is used across multiple NHS organisations and has become part of routine depression care in a number of services.
“Until now, delivering brain stimulation has typically presented practical barriers to widespread use in routine depression care,” said Dr. Kultar Garcha, Chief Medical Officer of Flow Neuroscience. “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.”
Available by prescription across the US
To support the US 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 via 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.
FL-100 is available in the United States from September 1, 2026.
Patients and healthcare professionals can learn more at www.flowneuroscience.com.
About Flow Neuroscience
Flow Neuroscience is developing a new generation of electronic medicine for mental health.
Founded in Sweden, in 2016 by clinical psychologist Daniel Månsson and computational neuroscientist Erik Rehn, Flow 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. Flow has been used by more than 65,000 people globally, is approved in the United States (FDA approval P230024), and is authorized for marketing in the UK, Europe and Australia.
Important Safety Information
Intended Use
The FL-100 Headset is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 and older who are not considered treatment refractory to medication.
For prescription use only (Rx only).
Contraindications
Do not use the device if you have:
- Open wounds, broken skin or damaged skin at the electrode site.
- Metallic skull reconstruction at the electrode site.
Warnings
Never change your treatment for depression (major depressive disorder) prior to discussing it with your medical provider.
The FL-100 Headset should never be applied to open wounds, damaged or irritated skin. New FL-100 Headset Pads should be used each time and should not be dry. Clean your forehead before using the device and never use tap water to wet Headset Pads.
Apply the FL-100 Headset only on the head as directed. Do not apply the headset anywhere except the head. Avoid activities that may cause the headset to move or change position during treatment. Keep the headset dry and out of the reach of children.
The FL-100 Headset should not be used around very strong magnetic fields, such as near an MRI machine.
Precautions
The device should only be used by people aged 18 years and older who are diagnosed with major depressive disorder and whose clinical course is supervised by a medical provider.
Discuss use with your clinician if you: are pregnant or think you might be pregnant, or become pregnant while using the device; currently have thoughts about suicide or harming yourself; have certain metal parts in or around the brain; have been diagnosed with epilepsy, seizures or a seizure disorder, or unexplained loss or alteration of consciousness; or have a chronic skin condition affecting the forehead or scalp.
There is a risk that the device is ineffective for an individual patient.
Ensure your forehead is free from makeup or hair products before starting stimulation, as not doing so can result in skin damage.
Possible Adverse Reactions
The most common adverse reactions include skin redness, itchy skin, stinging skin, skin irritation and headache.
For complete safety information, visit flowneuroscience.com/home/safety or speak with your healthcare provider.
Legal Manufacturer
Flow Neuroscience AB
Södra Tullgatan 3
211 40 Malmö, Sweden
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