GrayMatters Health, an Israeli-based digital health technology company, has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its product, Prism for post-traumatic stress disorder (PTSD). Prism is the first non-invasive self-neuromodulation adjunct digital therapy for PTSD.
The company uses a proprietary model to create a unique patient amygdala-derived biomarker, using synchronised data from several sessions of electroencephalograms (EEGs) and fMRIs.
The model is then embedded into the product, Prism which combines an EEG cap with the software, to train patients to control the biomarker signal, and hence control the emotional response.
The FDA 510(k) clearance is based on results of a study of 79 patients with chronic PTSD, at least one year after experiencing trauma.
"Prism for PTSD augments standard of care psychotherapy and pharmacotherapy therapies to enhance clinical outcomes. We have designed Prism for PTSD to fit into any outpatient or private clinic where mental healthcare professionals can use the product to empower patients to take an active role in their treatment journey, by enabling them to utilize self-developed strategies for lowering their emotional response. These skills are then honed and practiced throughout Prism for PTSD treatment and can be applied in their everyday lives."
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