Independent US launch resource
The first FDA-approved at-home tDCS headset for major depressive disorder is launching in the US in mid-2026.
Cortevi is building the most streamlined path to find out if the Flow Neuroscience FL-100 headset is right for you.
First FDA-approved at-home tDCS headset for moderate-to-severe depression.
Online evaluation + prescription + device shipped to your door.
New, non-pharmaceutical option for depression.
The Flow Neuroscience device is the FL-100, a wearable tDCS headset that delivers 2.0 mA of constant direct current to the dorsolateral prefrontal cortex through saline-soaked pads and electrodes for 30-minute sessions, paired with a companion behavioral therapy app. The system is prescription-only in the United States and is manufactured by Flow Neuroscience AB, a Swedish medical device company founded in 2016.
The FL-100 has 3 components working as one prescription system:
A lightweight plastic crown holds 2 saline-soaked sponge electrodes in fixed positions on the scalp.
The Flow companion app guides each session, monitors usage, controls the device stimulation, and presents the user's schedule.
The standard course is 5 sessions per week for the first 3 weeks (acute phase), then taper to 2-3 sessions per week through week 10 (continuation), with maintenance dosing as clinically indicated. Every FL-100 ships with a starter pack of electrode sponge pads.
The FL-100 holds FDA premarket approval P230024 issued December 8, 2025, the first PMA granted for an at-home tDCS device in the United States. The device is classified as Class III under product code JXK (cranial electrotherapy stimulator) and is indicated as monotherapy or as an adjunct to antidepressant medication for moderate-to-severe major depressive disorder in adults 18 and older. Prior medication failure is not required by the label.
Clinical efficacy rests on 4 evidence streams:
The device received FDA Breakthrough Device designation in 2022 and CE Mark Class IIa approval in the United Kingdom and the European Union prior to US clearance.
Full details and official labeling are available in the FDA Summary of Safety and Effectiveness (P230024).
Transcranial direct-current stimulation (tDCS) is a non-invasive neuromodulation technique that delivers a low-intensity constant electrical current (typically 1-2 mA) through scalp electrodes to modulate the resting membrane potential of underlying cortical neurons. The current does not fire neurons directly. It shifts the probability that targeted neurons will fire when the brain is active, which over repeated sessions produces durable changes in cortical excitability and circuit-level connectivity.
For major depressive disorder, the standard depression montage places the anode over the left dorsolateral prefrontal cortex (DLPFC) at the F3 site of the international 10-20 EEG system and the cathode over the right supraorbital region or the right DLPFC. Anodal stimulation increases excitability of the left DLPFC, a region consistently shown to be hypoactive in patients with major depressive disorder on functional imaging. The mechanism is hypothesized to restore prefrontal-limbic regulatory balance through cumulative long-term potentiation, with effects that build over a multi-week course rather than a single session.
Neuromodulation is the broader category. It covers transcranial direct-current stimulation (tDCS), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), vagus nerve stimulation, and deep brain stimulation.
Flow Neuroscience tDCS and traditional antidepressants address major depressive disorder through different biological pathways, different administration routes, and different side-effect profiles, with the FL-100 acting locally on prefrontal cortical excitability and antidepressants acting systemically on monoamine neurotransmitter systems.
Note: The FDA has not evaluated the FL-100 for direct superiority over SSRIs. Both can be used as monotherapy or in combination per the FL-100 label, and the best path depends on your specific clinical history.
| Feature | FL-100 (At-Home tDCS) | SSRI / SNRI Antidepressants |
|---|---|---|
| Mechanism | Anodal stimulation of left DLPFC; cortical excitability modulation. | Systemic increase in serotonin and/or norepinephrine availability. |
| Route | Topical, transcranial; 2.0 mA for 30-minute sessions. | Oral; daily dose. |
| Onset of meaningful response | 3-6 weeks of consistent sessions. | 4-8 weeks at therapeutic dose. |
| Common side effects | Itching, headache, transient redness. | Nausea, sexual dysfunction, weight change, sleep disruption, withdrawal symptoms. |
| Sexual side effects | None reported in registration trials. | Common across SSRI class. |
| Drug-drug interactions | Benzodiazepine use may reduce effectiveness. | Multiple, including bleeding risk and serotonin syndrome with co-administration. |
| Pregnancy considerations | Not certified for use during pregnancy. | Class-dependent; some agents avoided. |
| Discontinuation effects | Limited data. | Discontinuation syndrome documented for several agents. |
| FDA indication | Moderate-to-severe MDD, monotherapy or adjunct, adults 18+. | Varies by agent; broadly approved for MDD across severities. |
Comparison data is drawn from the FDA PMA P230024 summary of safety and effectiveness, the SSRI class labeling, and 2020-2025 meta-analyses on tDCS for major depressive disorder. The table is not a clinical recommendation. Treatment decisions require individual evaluation by a licensed clinician.
The FL-100 is designed with your safety built right in. Three smart safeguards work together to make at-home tDCS safe and easy for you:
The entire system is engineered so you don't have to adjust or calibrate anything yourself - it stays safely within the right ranges automatically.
At-home tDCS is safe when delivered through an FDA-approved device under clinical supervision. Safety conclusions apply to prescribed, on-label use of the FL-100 specifically. Off-label do-it-yourself tDCS rigs and unapproved consumer headsets do not share this safety profile and are not equivalent.
Common, transient side effects include skin tingling at electrode sites, mild headache, and brief redness. People with open wounds, broken skin, or metallic skull reconstruction at the electrode site should not use the device.
The FL-100 headset is positioned and used in 5 sequential steps following the F3-anode depression montage, with each session running 30 minutes at 2.0 mA inside the Flow companion app. The headset's fixed geometry does most of the placement work. Your job is skin prep, sponge saturation, fit check, and adherence.
Run the session in this order:
A prescription is required by federal law for the FL-100 in all 50 US states, because the FDA approved the device under PMA P230024 as a prescription-only Class III medical device. State-level telehealth prescribing rules add a second layer covering which clinicians can issue the prescription, whether a synchronous video visit is mandatory, and how the prescription is transmitted.
The FL-100 demonstrated response rates of 45-58% and remission rates in the same range at 10 weeks in the Empower pivotal sham-controlled trial, with statistically significant separation from sham on the Hamilton Depression Rating Scale, according to the FDA PMA P230024 summary of safety and effectiveness. Manufacturer-published real-world data covering more than 55,000 EU users since 2019 reports 77% of users feel better after 3 weeks of use.
The FL-100 and clinic-based repetitive transcranial magnetic stimulation (TMS) treat major depressive disorder through related but distinct neuromodulation pathways, with the FL-100 delivering low-intensity tDCS at home for 30 minutes per session and TMS delivering high-intensity magnetic pulses in a clinic for 30-40 minutes per session over 4-6 weeks. TMS produces direct neuronal firing at the stimulation site. tDCS produces subthreshold modulation that shifts firing probability. TMS evidence is stronger for treatment-resistant depression and is FDA-approved with a long track record. tDCS evidence is moderate, the device is cheaper, and the at-home delivery removes the daily clinic visit. The two are not mutually exclusive; there have been studies on sequencing them under clinician guidance.
The FL-100 label permits monotherapy or adjunctive use with antidepressants, with no requirement to discontinue current medication before starting tDCS, per the FDA PMA P230024 indication. Clinicians review concurrent medications during intake and coordinate with your existing prescriber when appropriate. Combined use is the most common pattern in the Empower trial population. However, clinical trials explicitly excluded patients who were using medications that alter cortical excitability, such as benzodiazepines or epilepsy medications, because these can interfere with the tDCS treatment.
The recommended schedule is 5 sessions per week for the first 3 weeks (acute phase) and 2-3 sessions per week through week 10 (continuation phase), with each session running 30 minutes at 2.0 mA through the F3-anode depression montage. Most patients in the Empower trial saw symptom reductions within three weeks. Clinical data showed a statistically significant difference in symptom improvement between the active and sham (placebo) groups as early as week 4.
The Flow headset is designed so that you don't have to guess where to place the treatment pads; they are built into a frame that automatically aligns them with the specific areas of your brain responsible for regulating mood. Once you put the headset on like a crown, it holds the positive electrode over your left forehead and the negative electrode over your right forehead to ensure the stimulation reaches the correct targets.
Independent meta-analyses report small but statistically significant effect sizes for tDCS in major depressive disorder, such as a 2026 individual patient data meta-analysis reporting a Hedges' d of 0.24. Data from individual clinical trials-rather than pooled meta-analyses-demonstrate that tDCS yields substantially stronger results when combined with antidepressants (response rates around 63%) compared to monotherapy (response rates around 43% to 48%). Clinical efficacy is also known to be negatively correlated with treatment-resistant depression, meaning non-response is higher among populations that have failed multiple prior treatments.
The Empower pivotal trial (174 participants, double-blind, sham-controlled, home-based) provided evidence supporting FDA approval in December 2025. However, the Empower trial did not resolve methodological concerns about placebo effects; instead, the FDA cited a moderate level of uncertainty regarding its benefit specifically due to unblinding, as many participants could correctly guess whether they were receiving the real treatment or a sham. Ultimately, the FDA's approval assessment reflects that the totality of the evidence demonstrates the device provides a probable benefit that outweighs its probable risks, despite unblinding uncertainties and conflicting results across the broader literature.
Yes, tDCS is legal to use at home in the US, but only with a prescription from a licensed clinician. DIY or unapproved tDCS devices are not the same and are not recommended.
The Flow Neuroscience FL-100 is not yet available for purchase in the United States. It's FDA-approved and expected to launch in summer 2026.
When it launches, the Flow FL-100 headset is expected to cost between $500 and $800 out of pocket. Insurance coverage and HSA/FSA options are still being worked out and will be announced closer to the launch.
Yes - the Flow Neuroscience FL-100 received full FDA approval in December 2025.
The most common side effects are mild and short-lived: a tingling or stinging feeling during sessions, temporary redness or irritation where the pads touch your skin, and occasional brief headaches. Serious side effects are very rare when you use fresh electrode pads as directed.
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Notice: Cortevi does not provide medical evaluation, prescription, or device fulfillment. Information on this page is educational and is not medical advice. The Flow Neuroscience FL-100 is a prescription-only Class III medical device cleared by the FDA under PMA P230024. Consult a licensed clinician before starting any treatment for major depressive disorder.