Flow Neuroscience Launches FL-100, First FDA-Approved At-Home tDCS Depression Treatment in US

Summary

Flow Neuroscience has launched FL-100 in the United States, marking the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for moderate to severe major depressive disorder (MDD). The prescription-only device, which combines a wireless headset with a companion app, delivers low-intensity electrical currents to the brain. Its FDA Premarket Approval (PMA P230024) is supported by phase 2 trial results published in Nature Medicine, showing a 57% remission rate at 10 weeks.