GrayMatters Health receives FDA 510(k) for PTSD neuromodulation therapy

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Israeli-based digital health technology company GrayMatters Health, which develops self-neuromodulation therapies for mental disorders, received FDA 510(k) clearance for its PTSD-focused neuromodulation therapy dubbed Prism.  

The company uses a proprietary model to create a unique patient amygdala-derived biomarker, using synchronized data from several sessions of electroencephalograms (EEGs) and fMRIs. 

The model is then embedded into the company’s product Prism, which combines an EEG cap with software, creating a neurofeedback device used to train patients to control the biomarker signal, and, therefore, control their emotional response. 

Studies have shown amygdala hyperactivity may explain PTSD symptoms, and plays a critical role in modulating negative affect and emotion. 

“I’m delighted the FDA has recognized the value of Prism for PTSD and we are excited to bring it to the U.S. market,” Oded Kraft, cofounder and CEO of GrayMatters Health, told MobiHealthNews in an email.  

“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 emotion response. These skills are then honed and practiced throughout Prism for PTSD treatment and can be applied in their everyday lives.”


Last year, GrayMatters closed a $10 million Series A financing round led by Japanese pharma group Otsuka.  

Another company using neuromodulation for patient treatment is Massachusetts-based Cognito Therapeutics, which offers an investigational medical device that uses non-invasive neuromodulation to treat people with neurodegenerative diseases like Alzheimer’s.

Joe Drygas and Randy Bush will offer more detail during the HIMSS23 session “The 5G Advantage: Advanced Connectivity for Life Sciences and Healthcare.” It is scheduled for Friday, April 21 at 10:30 a.m. – 11:30 a.m. CT at the South Building, Level 1, room S105 C.


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