FDA Approves Flow's FL-100, the First At-Home Transcranial Direct Current Stimulation (tDCS) Device for Depression Treatment

The U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA P230024) to Flow Neuroscience's FL-100, making it the first FDA-approved at-home brain stimulation device specifically indicated for depression. The prescription-only device delivers low-level electrical current to the brain and is backed by a randomized controlled trial showing a 57.5% remission rate in adults after 10 weeks of treatment. It requires clinician supervision.