GrayMatters Health’s Digital Therapy Device for PTSD Cleared

GrayMatters Health has received 510(k) clearance from the FDA for its Prism device, which provides digital self-neuromodulation therapy for treating post-traumatic stress disorder (PTSD).

The device uses biomarkers of brain activity associated with mental disorders gained from combining electroencephalogram data with functional magnetic resonance imaging to measure small changes in blood flow that occur with brain activity.

Using an interactive audio/visual interface, Prism for PTSD trains patients to use the device’s neurofeedback to self-modulate the biomarker and regain control of brain activity.

The company plans to evaluate Prism for additional mental conditions, such as major depressive disorder, attention deficit hyperactivity disorder, general anxiety disorder and borderline personality disorder.