FDA Clears Adjunctive Virtual PTSD Therapy For Market

A new product aimed at helping to treat post-traumatic stress disorder (PTSD) has been cleared for the United States market by the FDA.

GrayMatters Health, an Israeli digital health startup focused on mental health disorders, said last month that it had received a 510(k) clearance from the FDA to market Prism for PTSD, a self-neuromodulation product designed as an adjunct to standard-of-care therapy.

The product uses neurofeedback to help train patients to use self-neuromodulation techniques to alleviate symptoms of PTSD.

The technology is based on biomarkers of brain mechanisms associated with mental disorders, which the company developed using electroencephalogram and functional MRI data. These biomarkers are referred to as EEG-fMRI-patterns, or EFPs. Prism then uses those biomarkers, along with an interactive audiovisual interface, to help patients lower an amygdala-derived EFB biomarker associated with the emotional regulation system.

The approval opens up a major market for the company. According to the U.S. Department of Veterans Affairs, about 6% of Americans will experience PTSD at some point in their lives. Globally, the company said, about 250 million people have PTSD.

Oded Kraft, MBA, the company’s CEO, said the FDA clearance is an affirmation of the efficacy of their noninvasive treatment.

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