CaRi-Heart
AI technology that quantifies coronary inflammation to predict cardiac events up to 10 years in advance
Company profile
Company profile
Caristo Diagnostics is a global leader in cardiovascular disease diagnostics and risk prediction, spun out from the University of Oxford. The company has developed CaRi-Heart®, a breakthrough AI technology that analyzes routine coronary computed tomography angiography (CCTA) scans to visualize and quantify coronary inflammation—the otherwise invisible disease mechanism responsible for many fatal heart attacks and strokes. The technology applies advanced AI algorithms to standard cardiac CT imaging to detect inflammation that traditional imaging methods cannot see, transforming CCTA from a diagnostic tool into a powerful prevention platform. Caristo's flagship product includes the FAI-Score™ for inflammation measurement, CaRi-Plaque™ Analysis for plaque assessment, and an Individualised Risk Score that outperforms traditional risk prediction models. The technology has been validated in landmark clinical studies including the ORFAN registry, the world's largest coronary CT registry with 40,000+ patients, published in The Lancet. Results demonstrate that CaRi-Heart can predict fatal and non-fatal cardiac events at least 10 years in advance, even in patients without obstructive coronary artery disease. The company serves clinicians, health systems, pharmaceutical companies conducting clinical trials, and patients seeking advanced cardiac risk assessment. CaRi-Heart technology is currently in clinical use across the UK, European Union, and Australia, with investigational use status in the United States.
Company description Caristo Diagnostics official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Company milestones
Selected as World Economic Forum 2026 Technology Pioneer (June 2026). Appointed Stephen Deitsch as CEO (April 2026). Published landmark ORFAN study results in The Lancet (May 2024). FDA 510(k) clearance for CaRi-Plaque™ [K242240]. Featured in 'Super Agers' book by Dr. Eric Topol.
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
AI technology that quantifies coronary inflammation to predict cardiac events up to 10 years in advance
AI-powered individualized cardiac risk prediction model
FDA-cleared plaque analysis technology for coronary artery assessment
Biomarker that quantifies coronary artery inflammation from CCTA scans
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Journal of the American College of Cardiology · Jun 30, 2026
Non-invasive assessment of coronary inflammation improves the diagnostic accuracy of coronary death in post-mortem CT angiography.Journal of cardiovascular computed tomography · Jun 26, 2026
Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics.American heart journal · Dec 1, 2025
Coronary inflammation and cardiovascular risk in breast cancer after radiotherapy.European heart journal · Aug 1, 2025
Cost-effectiveness of a novel AI technology to quantify coronary inflammation and cardiovascular risk in patients undergoing routine coronary computed tomography angiography.European heart journal. Quality of care & clinical outcomes · Jun 23, 2025
Association of coronary inflammation with plaque vulnerability and fractional flow reserve in coronary artery disease.Journal of cardiovascular computed tomography · Jan 1, 2025
Clinical validation
NCT05169333 · Sponsor · RECRUITING
Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study (SMART-CCTA-1)NCT06986733 · Sponsor · NOT YET RECRUITING
Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT ScansNCT05058690 · Sponsor · NOT YET RECRUITING
Regulatory
K242240 · 510k · Feb 20, 2025
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Fatal and non-fatal cardiac events including heart attack and heart failure
Among patients with no or minimal coronary plaque but abnormal FAI-Score
Among patients with no or minimal coronary plaque but abnormal FAI-Score
When CaRi-Heart Risk Score presented to clinicians
Cost-effectiveness analysis of implementing CaRi-Heart technology across NHS for cardiac risk prediction and prevention
12% reduction in cardiac deaths, 11% reduction in myocardial infarctions, 4% reduction in strokes, 4% reduction in heart failure events; ICER of £1,371-£3,244 per QALY (well below NHS threshold)
Predicting cardiac events in patients undergoing CCTA, particularly those without obstructive coronary artery disease
9.5-fold higher risk prediction for cardiac mortality and 5.5-fold higher risk for MACE in high-risk patients; 45% change in clinical management decisions
05 · Leadership
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06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies applying AI to cardiovascular disease detection, ECG/EKG analysis, heart failure management, cardiac imaging, arrhythmia detection, or cardiovascular risk assessment. Includes AI-powered cardiac diagnostics, non-invasive hemodynamic monitoring, and tools for early detection and personalized management of heart conditions.
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