FDA Clears cranial electrotherapy stimulation device for Home-Based Treatment of Major Depressive Disorder

The FDA has approved Flow, a prescription home-use cranial electrotherapy stimulation device, for treating moderate to severe major depressive disorder (MDD) in adults aged 18 years and older. It can be used alone or alongside antidepressant medications in the current depressive episode and is intended for patients who are not treatment-refractory to medication.

Currently, depression affects more than 20 million U.S. adults, a 60% increase over the last decade. Around a third of these patients are not responsive to antidepressants, and many stop treatment because of side effects such as sexual dysfunction, weight gain, a sense of feeling emotionally blunted, and many others.

“We’re on a mission to make effective, affordable non-drug treatment available to the millions of Americans suffering from depression,” said Erin Lee, CEO of Flow Neuroscience.

“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.”

Transcranial direct current stimulation, or tDCS, the technology behind Flow, is backed by more than 9000 publications and over 25 years of clinical research in depression treatment, stroke recovery, pain management, and other use-cases. Flow's neurostimulation device applies a gentle electrical current to the prefrontal cortex, the part of the brain involved in mood regulation and stress response, which is often underactive in people with depression.

To prove device effectiveness, Flow published their landmark randomized controlled clinical study in Nature Medicine, showing that patients using Flow’s FL-100 tDCS device experienced symptom reductions as early as within 3 weeks. These results revealed a clinically meaningful response to treatment and side effects were, in general, mild and transient.

Flow’s clinical trial was the largest of its kind and demonstrated that for the first time at scale, a fully remote, home-based neuromodulation treatment is effective in treating major depression. Active tDCS treatment with FL-100 not only outperformed sham stimulation but achieved two to three times higher remission and response rates, with 58% of patients in remission by the end of the 10 week study. Results were also observed among patients already on medication or psychotherapy who used FL-100 adjunctively, making it far closer to real-world conditions than most previous trials.

“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,” added Flow’s Chief Medical Officer, Dr. Kultar Garcha.

Daniel Månsson, co-founder and Chief Scientific Officer of Flow Neuroscience said, “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. The approval of FL-100 in the US will now offer millions of patients an accessible and effective non-drug treatment option."

Flow has been used by more than 55,000 people in the EU, UK, Switzerland, and Hong Kong. In the UK, it is used by multiple NHS trusts and is prescribed by doctors in their public health system. Flow expects the device to be available in the U.S. as early as Q2 2026.

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

The Flow System received Breakthrough Device Designation from the FDA in 2022, a program designed for technologies that offer potentially more effective treatment or diagnosis for debilitating diseases. The company is also planning to evaluate its platform as a treatment for additional neuropsychiatric indications, including traumatic brain injury, addiction and sleep disorders.

Reference:

Woodham, R.D., Selvaraj, S., Lajmi, N. et al. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med 31, 87–95 (2025). https://doi.org/10.1038/s41591-024-03305-y