The US Food and Drug Administration (FDA) has approved Flow Neuroscience’s home-based brain stimulation device for the treatment of depression.
According to the Centers for Disease Control and Prevention, depression rates in the US have increased by 60% in the past decade, affecting more than 20 million adults.
Flow’s FL-100 delivers a mild electrical current to the part of the brain that regulates mood and is designed for use at home under remote supervision. It is the first such device to be approved in the US.
The device is approved to treat moderate to severe major depressive disorder in adults aged 18 and older as a stand-alone treatment or in combination with other treatments that are not considered drug-resistant.
Flow plans to launch the device in the US in the second quarter of 2026 as a prescription-only medication.
CEO Erin Lee told Reuters that the company is targeting a retail price in the US of between $500 and $800. She added that Flow is in talks with insurance payers and plans to announce a partnership with coverage in early 2026.
Flow says the device is used by more than 55,000 people in Europe, the U.K., Switzerland, and Hong Kong.
The FDA approval was based on a mid-study in which 58% of patients achieved remission after 10 weeks, including many who were already taking medication or undergoing therapy. Among users worldwide, 77% reported improvement in symptoms within three weeks, the company said.
Patients typically complete a 12-week course, starting with five sessions per week for three weeks, then tapering to two to three sessions per week for the remaining nine weeks. Each session lasts 30 minutes.
Side effects are generally mild and temporary, including skin irritation, headache, and a tingling sensation at the electrode sites, Flow said, adding that skin burns have occurred when the device’s pads are reused or dry out.