FDA Clears First At-Home Brain-Stimulation Device for Major Depression

The FDA has approved Flow Neuroscience’s FL-100 transcranial direct-current stimulation (tDCS) system, making it the first at-home, prescription neuromodulation therapy authorized in the United States for adults with moderate to severe major depressive disorder (MDD). Clinicians will be able to prescribe the device as a stand-alone or adjunctive treatment when it becomes available in the US in the second quarter of 2026, according to the company.¹

The authorization arrives as depression rates continue to climb. More than 20 million US adults live with depression, a 60% increase over the past decade, according to the CDC.² Moroever, approximately one-third do not respond adequately to antidepressant medications or discontinue them due to adverse effects such as sexual dysfunction, weight gain, or emotional blunting.²

“We’re on a mission to make effective, affordable non-drug treatment available to the millions of Americans suffering from depression,” Erin Lee, CEO of Flow Neuroscience, said in a statement. “Flow’s FDA approval is a watershed moment for the treatment of depression: the first step in moving from pharmaceutical treatments to tech-based therapies with minimal side effects.”¹

The Flow-100 Device

The FL-100 device delivers low-intensity electrical stimulation to the prefrontal cortex, the region of the brain involved in mood regulation and stress response. Activity in this area of the brain is often diminished, according to Flow. tDCS has accrued more than 25 years of clinical investigation across depression, post-stroke rehabilitation, pain conditions, and other neurologic indications, with more than 9,000 publications cited by the company.

Flow reports that more than 55,000 people in Europe, the UK, Switzerland, and Hong Kong have already used the system, including within several NHS trusts. US access has expanded incrementally since the FDA awarded the device Breakthrough Device Designation in 2022.¹

Pivotal clinical evidence

The FDA decision draws heavily on results from Flow’s randomized, double-blind, sham-controlled trial published in Nature Medicine,³ the largest remote tDCS depression study to date, according to the Flow statement. The 10-week trial enrolled 174 adults with at least moderately severe MDD (baseline Hamilton Depression Rating Scale [HDRS] mean ≈19). Participants self-administered either active or sham stimulation at home under remote supervision.³

Active tDCS produced significantly greater symptom reduction than sham: a mean HDRS improvement of 9.41 points versus 7.14 points (95% CI, 0.51–4.01; P =.012). Discontinuation rates were similar, and adverse events were generally mild and transient. The protocol comprised 5 sessions per week for 3 weeks, then 3 sessions weekly for 7 weeks, followed by a 10-week open-label phase.³

The findings align with outcomes reported in the company’s larger real-world data set. “Among our real world users, 77% see improvements in as little as three weeks. Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care,” Kultar Garcha, MD, Flow’s chief medical officer, noted.¹

In the phase 2 pivotal trial, active stimulation also achieved 2- to 3-fold higher remission and response rates than sham, with more than half (58%) of participants meeting remission criteria at 10 weeks. Investigators reported poisitve results among participants recieving concurrent pharmacotherapy or psychotherapy as well, conditions more likely in real-world use than seen in "most previous trials," according to the Flow statement.

Reported side effects are generally mild and transient; the most common include skin dryness, irritation, or redness after prolonged use, transient headache, and stinging or itching at the stimulation site. Skin burns have occurred when electrode pads were reused or applied after drying out.¹

Potential: Expansion of Access to Care

The approval adds a non-drug, home-based option to depression management pathways at a time when health systems are pressed to expand access to care. “For more than 6 years since the device’s launch in Europe, we’ve been building an evidence base globally with clinical trials, peer-reviewed research, and real-world case reports," Daniel Månsson, Flow’s co-founder and chief scientific officer, said. "The approval of FL-100 in the US will now offer millions of patients an accessible and effective non-drug treatment option."¹

Flow will require a prescription from a licensed healthcare provider and is expected to be available for download through iOS and Android app stores in Q2 2026. The FL-100 is indicated for adults aged 18 years and older with moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, provided they are not considered treatment refractory.

“We are committed to ensuring that Flow becomes a part of a standard treatment pathway for depression care,” Lee said. “We are singularly focused on helping as many patients as possible achieve remission from depression.”

Flow plans to evaluate its platform for additional neuropsychiatric indications, including traumatic brain injury, addiction, and sleep disorders.

More information, including updates on U.S. availability, is available at www.flowneuroscience.com; resources for clinicians are available at https://hcp.flowneuroscience.com/.