FDA Gives Breakthrough Device Status to nVNS for PTSD

The Food and Drug Administration (FDA) on January 12, 2022, granted breakthrough status to the GammaCore non-invasive Vagal Nerve Stimulation (nVNS) device for posttraumatic stress disorder (PTSD). This was based on our study showing a 31% reduction in PTSD symptoms compared to a sham stimulation after three months of twice daily treatment. tcVNS reduces sympathetic and inflammatory function and thus has a beneficial effect on PTSD neurobiology. Breakthrough designation allows the FDA to fast track approval for this condition which […]