BETA
Developer of Prism, an EEG neurofeedback platform using fMRI-informed brain biomarkers for adjunctive PTSD treatment and a separate depression wellness protocol.
GrayMatters Health develops and markets Prism, a neurofeedback platform for mental healthcare clinics. Founded in 2018 by Oded Kraft, Rani Cohen and Shai Attia, the company lists headquarters in Haifa, Israel and U.S. headquarters in New York, New York, United States. Kraft is CEO and President; Kirk Thelander is Chief Commercial Officer.
Prism uses EEG signals and models developed from paired EEG and fMRI data to provide feedback through an interactive simulation. Patients practice personal mental strategies to influence the feedback. Its PTSD protocol received FDA 510(k) clearance in March 2023 as an adjunct to other interventions. The depression protocol is marketed separately as general wellness; its clinical pilot does not establish FDA clearance for depression.
The company announced a $10 million Series A led by Otsuka Medical Devices in 2022, a €2.5 million EIC grant that year and a separate EIC equity investment in 2023. U.S. commercial launch followed in January 2024. Provider publications from NYU Langone and Atrium Health document clinical use, while Prism360 and Prism Imagine expand clinic support and patient engagement. Revenue and current total funding were not verified.
Prism for PTSD is FDA-cleared under K222101 as an adjunct to standard care. The manufacturer’s general-wellness/exemption positioning for its Depression protocol is not a cleared depression-treatment indication. Prism Imagine’s visualization functions likewise do not automatically inherit the PTSD clearance. [2][12][15][17][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [6][4]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
Documented commercial product families.
Software uses EEG input and an interactive audiovisual simulation for neurofeedback training; it runs on a laptop with compatible external EEG hardware. [13][12][16][18][11][8]
FDA-clearedCommercially available in U.S. clinics; January 2024 official U.S. launch.
Uses a ventral-striatum/reward-system biomarker and interactive simulation to train regulation of brain activity. [24][25][9]
Marketed · regulatory scope variesMarketed as part of Prism Suite.
Turns a patient’s written mental strategy into an image that can be refined, saved and revisited between or after clinic sessions. [29][24]
Marketed · regulatory scope variesCommercial launch announced May 12, 2026.
Provider report describes Prism use at Behavioral Health Charlotte within an overall PTSD treatment plan. A patient example does not establish system-wide deployment or comparative efficacy. [8]
Douglas Nemecek joined as an advisor to support payer strategy. His prior Cigna role does not imply Cigna coverage or endorsement. [28]
Generative AI visualization tool introduced to help patients create and retain an image of their personal mental strategy. Separate therapeutic efficacy or FDA authorization not established. [29]
Program offers financing access, benefits investigation, prior authorization assistance and implementation support. Company then reported more than 30 U.S. clinics; this is a dated, unaudited figure. [23]
Company-funded pilot analyzed 34 completers after ten sessions. Exploratory symptom improvements support further controlled study; they do not establish a cleared depression indication. [9]
Company named Center for Neuropsychiatry and Brain Stimulation in North Carolina and Bespoke Treatment in California as initial treatment centers. January 4 dateline retained despite inconsistent article header. [22]
Fruchter et al. reported a prospective, single-arm, open-label adjunctive study with 15 sessions and follow-up. The absence of a sham control limits causal interpretation of symptom improvements. [18]
EIC Fund invested after its 2022 grant. The equity amount was not disclosed in this announcement. [20]
FDA cleared Prism under K222101 for adjunctive treatment of PTSD symptoms using EEG biofeedback. [13]
Otsuka Medical Devices led the round and obtained certain Prism rights in Japan and other Asian countries. This does not establish a current commercial launch in those markets. [27]
Company reports a September 2022 EIC grant supporting product development and clinical evaluation. [20]
Company and McLean Hospital announced BIRD Foundation support for development of neurofeedback for depression with anhedonia. Amount not established here. [21]
Founded by Oded Kraft, Rani Cohen and Shai Attia around licensed brain-biomarker technology. [15]
Accessed 10/29/2026