Flow Neuroscience wins first FDA approval for at-home brain-stimulation depression treatment

Flow Neuroscience has received FDA approval for its at-home brain-stimulation device for major depressive disorder (MDD), marking the first time U.S. clinicians can prescribe a non-drug, at-home therapy as either a stand-alone or adjunctive treatment for adults with moderate to severe depression.

The decision allows use of the company’s Flow device, which uses transcranial direct current stimulation (tDCS), a form of neurostimulation backed by more than 25 years of research. Depression affects more than 20 million U.S. adults—up 60% in the last decade—and about one-third of patients do not respond to medication, often stopping treatment due to side effects.

“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.”

The Flow device applies a low electrical current to the prefrontal cortex, the brain region involved in mood regulation. In a randomized controlled trial published in Nature Medicine, users of the FL-100 device saw symptom reductions within three weeks, with side effects described as generally mild and transient.

The study—the largest of its kind—found that active tDCS significantly outperformed sham treatment, producing two to three times higher remission and response rates. By the end of the 10-week trial, 58% of patients achieved remission. Benefits also extended to patients already receiving psychotherapy or medication.

“Among our real world users, 77% see improvements in as little as three weeks,” said Kultar Garcha, Flow’s chief medical officer. “Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care.”

Co-founder and Chief Scientific Officer Daniel Månsson noted that the device has been used by more than 55,000 people across Europe, the UK, Switzerland and Hong Kong. “The approval of FL-100 in the U.S. will now offer millions of patients an accessible and effective non-drug treatment option,” he said.

The company plans to make the device available in the U.S. as early as the second quarter of 2026. Flow previously received Breakthrough Device Designation in 2022 and aims to study its platform for additional conditions, including traumatic brain injury, addiction and sleep disorders.

“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.”

Recent advances in noninvasive neuromodulation and digital mental health

Flow’s FDA approval comes amid a period of rapid advancement in noninvasive neuromodulation and digital mental health technologies. Over the last several years, researchers and manufacturers have accelerated development of devices that deliver targeted electrical or magnetic stimulation to modulate brain activity linked to mood, anxiety, and cognitive function.

One of the most significant developments is the increasing shift toward home-based and remote-supervised devices. Traditionally, neuromodulation treatments such as repetitive transcranial magnetic stimulation (rTMS) required in-clinic visits several times per week, limiting access for many patients. Newer technologies—including tDCS and other low-intensity stimulation platforms—are designed to be safe enough for home use while maintaining clinical effectiveness. These systems often integrate mobile apps, symptom-tracking tools, and clinician dashboards, reflecting a broader movement toward hybrid digital-therapeutic models.

In parallel, clinical research on neuromodulation for depression has expanded dramatically. Large-scale trials, machine-learning-guided stimulation protocols, and personalized dosing strategies are becoming more common. Investigators are also studying how brain-stimulation devices can complement existing treatments, especially for the substantial share of patients who do not respond to medication alone. Early evidence suggests that combining neuromodulation with behavioral therapies or antidepressants may enhance outcomes without adding significant side effects.

Beyond depression, developers are exploring applications in anxiety disorders, smoking cessation, chronic pain, insomnia, PTSD and traumatic brain injury. Mayo Clinic, Stanford, and other research centers are evaluating portable neurostimulation tools that target specific circuits associated with rumination, anhedonia, and emotional regulation.

At the same time, venture investment in digital mental health and neurotechnology remains strong, with companies pursuing FDA pathways for everything from AI-powered diagnostics to VR-based exposure therapy. The convergence of neurostimulation, wearable sensors, and software-enabled monitoring is driving a new generation of “precision psychiatry” tools that aim to tailor treatment to each patient’s neurobiological profile.

Flow’s approval signals that regulators are increasingly receptive to these technologies as evidence quality improves. As more devices demonstrate real-world safety and efficacy, experts expect at-home neuromodulation to play a growing role in expanding access to depression care, particularly for patients who cannot tolerate or do not respond to traditional medications.