FDA approves 1st at-home device for treating depression
Big news for mental health: the FDA just approved FL-100, the first at-home brain-stimulation device for people with moderate to severe depression.
Made by Flow Neuroscience, it uses gentle electrical currents (tDCS) to target the part of your brain linked to mood—offering hope especially for those who haven't found relief with antidepressants or can't take them due to side effects.
How it works and what's next
In a clinical trial, users saw their depression symptoms drop by 58% after 10 weeks.
The FL-100 comes as a headset paired with an app that guides you through sessions remotely.
Already used by about 30,000 people in Europe and 55,000 globally since 2019, it's set to launch in the US by mid-2026—making tech-based mental health support more accessible and less reliant on meds.