FDA Approves First Home-Use Headset to Treat Depression in US

The US Food and Drug Administration approved Flow Neuroscience’s headset that uses electrical currents to treat depression at home, the first device of its kind cleared for sale in the country.

Called FL-100, it weighs less than a pair of over-the-ear headphones and the company said thursday it will be available in the second half of 2026. It’s been sold since 2020 in Europe, and customers can get it from Flow’s website for 459 euros ($537). Patients in the US will need a prescription, and the price will be roughly the same, Flow Chief Executive Officer Erin Lee ...