January 2026 BrainsWay Ltd. announced that Neurolief’s Proliv™Rx Neuromodulation System received U.S. FDA Premarket Approval (PMA) for treating adults with major depressive disorder (MDD) who did not achieve sufficient improvement from at least one prior antidepressant medication. The device uses external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) and can be used at home or in clinical settings, expanding non-invasive neuromodulation options for depression treatment.
December 2025 Flow Neuroscience AB received U.S. FDA approval for its FL-100 headset, a transcranial direct current stimulation (tDCS) device designed for home-based treatment of moderate-to-severe major depressive disorder. The approval expanded access to prescription digital neuromodulation therapy outside traditional clinical environments.