FDA Grants 501(k) Clearance for PTSD Self-Neuromodulation Tool

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the first non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder (PTSD) called Prism for PTSD.

The tool, developed by GrayMatters Health (GMH), represents the first platform for PTSD to use advanced statistical models fusing EEG and fMRI data for biomarkers in the brain-mechanism-specific activity associated with mental disorders by using biomarkers with an interactive audio and visual interface to help users regain control over the relevant brain activity.

The platform used self-neuromodulation techniques to lower the amygdala-derived-EPP biomarker, which is linked to the amygdala and emotion regulation system.

The clearance is based on the results of a study involving 79 patients with chronic PTSD who were at least 1 year since experiencing trauma.

"The study leading to Prism for PTSD's 510(k) clearance resulted in high quality clinical data that exemplifies the efficacy and safety of this innovative device," said professor Charlie Marmar, Principal Investigator of the study at NYU Langone, in a statement. "Results demonstrated a high rate of symptom improvement, a low rate of adverse event and a low attrition rate. I am encouraged that Prism, as an adjunctive therapy, will significantly benefit patients with PTSD and allow clinics to offer more options and better outcomes."