Flow Neuroscience Launches FL-100 in the US as First FDA-Approved At-Home tDCS Treatment for Depression
核心洞察
Flow Neuroscience (搜索) has launched FL-100 (搜索) in the US, the first FDA-approved at-home transcranial direct current stimulation treatment for moderate to severe major depressive disorder (搜索).
The prescription-only headset delivers gentle electrical current to the left dorsolateral prefrontal cortex (搜索) and is paired with an app for symptom tracking and clinician monitoring.
In the pivotal trial published in Nature Medicine, 57% of patients achieved remission (MADRS <=12) at 10 weeks on a protocol of 15 sessions in 3 weeks, then 3 weekly.
Flow Neuroscience (搜索) announced that FL-100 (搜索) is now available by prescription across the United States, bringing the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for depression to the US market. The device is intended for the treatment of moderate to severe major depressive disorder (搜索) 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, and the company said it is available in the United States from September 1, 2026.
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. 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, and the economic burden of major depressive disorder (搜索) 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 company noted.
"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 (搜索). "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."
Device Design and Clinical Evidence
Flow Treatment combines the FL-100 (搜索) Headset with a companion app. The headset applies a gentle electrical current to the left dorsolateral prefrontal cortex (搜索), 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 (搜索). "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."
Prescription Pathways and Clinician Support
To support the US launch, Flow is training clinicians nationwide and establishing simple prescription pathways designed to make FL-100 (搜索) 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.
Safety Profile and Contraindications
The FL-100 (搜索) Headset is for prescription use only. It should not be used by patients with open wounds, broken skin or damaged skin at the electrode site, or with metallic skull reconstruction at the electrode site. The device should only be used by people aged 18 years and older who are diagnosed with major depressive disorder (搜索) and whose clinical course is supervised by a medical provider. New FL-100 Headset Pads should be used each time and should not be dry; the forehead should be cleaned before use and tap water should never be used to wet the pads. The headset should not be used around very strong magnetic fields, such as near an MRI machine.
Clinicians should be consulted if a patient is pregnant or may become pregnant, currently has thoughts about suicide or self-harm, has certain metal parts in or around the brain, has been diagnosed with epilepsy, seizures or a seizure disorder, or unexplained loss or alteration of consciousness, or has a chronic skin condition affecting the forehead or scalp. The company noted there is a risk that the device is ineffective for an individual patient. The most common adverse reactions include skin redness, itchy skin, stinging skin, skin irritation and headache.
Flow Neuroscience (搜索), founded in Sweden in 2016, is developing a new generation of electronic medicine for mental health. Its first treatment, Flow, combines tDCS with a companion app to support treatment delivery, symptom tracking and clinician monitoring. The treatment is approved in the United States (FDA approval P230024) and is authorized for marketing in the UK, Europe and Australia.