FDA Approves At-Home Brain Stimulation Device for Depression

The FDA has approved Flow FL-100, an at-home brain stimulation device from Flow Neuroscience, for treating major depressive disorder (MDD). The headset uses transcranial direct current stimulation (tDCS) to modulate neuronal activity and is controlled via a smartphone app. This marks the first FDA-approved at-home non-drug therapy for MDD, usable alone or with medication. The approval was based on a 2024 Nature Medicine clinical trial showing high efficacy and safety. Side effects include headaches, ringing in the ears, and skin irritation. The device is expected to retail between $500 and $800 in the U.S. later this year. It has been approved in England since 2019. Previous non-invasive brain stimulation treatments like rTMS and ECT required clinic visits, limiting accessibility. The editorial in Brain Stimulation notes that the Hamilton Depression Rating Scale reduction difference (treatment ~9 vs. sham ~2) may be below clinically meaningful thresholds. Flow Neuroscience CEO Erin Lee announced the pricing target. The device is for adults with moderate to severe MDD not resistant to medication like Prozac.