Flow Neuroscience has received FDA approval for its FL-100, an at-home transcranial direct current stimulation (tDCS) device for the treatment of moderate to severe major depressive disorder. The device is expected to be available in the United States in Q2 2026.
The approval marks the first time an at-home brain stimulation device has been cleared by the FDA as both a stand-alone and adjunctive treatment for adults with depression. Flow received Breakthrough Device Designation from the FDA in 2022.
The device applies a gentle electrical current to the prefrontal cortex, the part of the brain involved in mood regulation and stress response. Depression currently affects more than 20 million adults in the United States, a 60% increase over the last decade, according to the company. Around a third of patients do not respond to antidepressants, and many stop 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.”
Flow published a randomized controlled trial in Nature Medicine showing patients experienced symptom reductions within three weeks. The trial reported a 58% remission rate by the end of the 10-week study, with active tDCS achieving two to three times higher remission and response rates compared to sham stimulation. Side effects were generally mild and transient, including skin dryness, irritation, and headache.
“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,” said Dr. Kultar Garcha, Chief Medical Officer.
Flow has been used by more than 55,000 people in the EU, UK, Switzerland, and Hong Kong since launching in Europe in 2019. In the UK, multiple NHS trusts use the device. The company is also evaluating the platform for additional indications including traumatic brain injury, addiction, and sleep disorders.
Flow Neuroscience was founded in Sweden in 2016.
