An at-home brain stimulation headset goes on sale in the US

Flow Neuroscience, based in Malmö, put its FL-100 headset on sale in the United States in early September 2026. It is the first at-home brain stimulation device the FDA has approved for major depressive disorder; the agency granted premarket approval in December 2025, and this month’s news is that patients can actually get one.

The device delivers transcranial direct-current stimulation — a weak constant current, between 0.5 and 2.0 mA, aimed at the left dorsolateral prefrontal cortex. It is prescription-only, for adults with moderate to severe depression in a current episode who are not treatment-refractory, and it can be used alone or alongside medication. The protocol runs fifteen sessions over three weeks, then one session a week.

The pivotal trial, published in Nature Medicine in 2024, reported that 57% of participants in the active arm reached remission at ten weeks. Flow says more than 65,000 people have used its headsets in the UK, Europe and Australia.

Cost sits outside the clinic too: roughly $2,200 for the initial ten-week course and $325 for each additional four weeks. Insurance coverage is the open question the launch does not answer.