U.S. FDA Grants GrayMatters Health 510(k) Clearance to Market Prism for PTSD

From GrayMatters: Complete Post through this link…

GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental disorders, announced today that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its flagship product, Prism for PTSD, the first non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder (PTSD).

GMH is the first to use advanced statistical models fusing EEG and fMRI data to develop biomarkers of brain-mechanism-specific activity associated with mental disorders, named EEG-fMRI-Pattern (EFP). The company’s products use these biomarkers with an interactive audio/visual interface to help patients regain control (agency) over the relevant brain activity.

Prism for PTSD trains patients to lower the amygdala-derived-EFP biomarker, which is associated with the amygdala and emotion regulation system, using self-neuromodulation techniques (through neurofeedback).

Prism for PTSD has the potential to improve the lives of the millions of Americans living with PTSD,” said Oded Kraft, Co-founder and CEO of GrayMatters Health. “Gaining FDA clearance affirms the value of bringing this innovative and clinically proven, non-invasive technology to mental disorder treatment. We are eager to place Prism in the hands of mental healthcare professionals, in the US and abroad, to help patients across the world living with PTSD”

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