Products

CaRi-Plaque
Caristo Diagnostics
Cardiology AI
CaRi-Plaque is an FDA-cleared, AI-assisted image analysis application by Caristo Diagnostics for non-invasive analysis of coronary anatomy and pathology from routine coronary CT angiography (CCTA) scans, determining the presence, extent, and severity of coronary plaques and quantifying luminal stenosis.

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About Caristo Diagnostics

Caristo Diagnostics is a global leader in AI-powered cardiac and vascular disease diagnostics and risk prediction, spun out from the University of Oxford. The company’s flagship technology, CaRi-Heart®, utilizes advanced AI algorithms to analyze routine cardiac CT angiography (CCTA) scans. This innovative approach allows for the visualization and quantification of perivascular fat inflammation, a previously invisible yet critical biomarker for coronary artery disease (CAD) and a strong predictor of future cardiac events, often years before symptoms manifest.

For physicians, CaRi-Heart provides a comprehensive report that includes the patient-specific Fat Attenuation Index (FAI), a patented biomarker for coronary inflammation, and an individualized CaRi-Heart Risk score, which assesses the absolute 8-year risk of a fatal heart attack by integrating inflammation status with standard clinical risk factors and plaque presence. The technology aims to transform cardiac care from a reactive model to a proactive one, enabling earlier detection, personalized prevention strategies, and refined treatment decisions. Caristo also offers CaRi-Plaque™ technology for quantitative characterization of coronary plaque and stenosis. The CaRi-Heart technology is CE Mark certified for use in the UK, EU, and Australia, and the company is actively pursuing FDA clearance and CPT codes for broader adoption in the U.S.

Focus Areas

cardiac disease diagnostics vascular disease diagnostics risk prediction heart attack prevention stroke prevention diabetes risk assessment coronary inflammation plaque analysis AI-assisted imaging CCTA analysis

Business Intelligence

Key InvestorsOxford Science Enterprises, BGF, Longwall Venture Partners, Oxford Investment Consultants LLP, Oxford University, Oxford Technology Investment Fund, HealthTech Arkansas Programs, HeartX Accelerator, MedAxiom, Oxford Technology Management
PartnershipsMedAxiom, NHS AI Stage 3 Award, Biograph (US study), Cromwell Hospital, Hooke London, myGP Clinic, Groupe Prive Hospitalier Ambroise Paré Hartmann, major global pharmaceutical and biotech companies, Aetna, Cigna, Humana, UnitedHealthcare (coverage), Centers for Medicare & Medicaid Services (CMS)
TechnologyCaRi-Heart® technology, CaRi-Plaque™ technology, AI-assisted diagnostics, cloud-based Software as a Service (SaaS) medical device, advanced AI algorithms applied to routine cardiac CT scans (CCTA), Fat Attenuation Index (FAI-Score™)
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Cardiac Disease Diagnostics
Caristo Diagnostics specializes in advanced cardiac disease diagnostics through its AI-enabled CaRi-Heartu00ae and CaRi-Plaqueu2122 technologies. These solutions quantify coronary inflammation (FAI-Scoreu2122) and characterize plaque based on routine Coronary Computed Tomography Angiography (CCTA) images, aiding in the diagnosis and management of coronary artery disease (CAD).
Vascular Disease Diagnostics
The company's platforms extend to broader vascular disease diagnostics, utilizing AI-assisted imaging to assess arterial health beyond just the coronary arteries, contributing to a comprehensive understanding of cardiovascular risk.
Risk Prediction & Prevention
Caristo provides individualized risk scores (CaRi-Heart Risk Score) that integrate inflammation, plaque burden, and clinical risk factors to predict the absolute risk of fatal cardiac events up to 10 years in advance, even in patients with non-obstructive CAD. This enables proactive, personalized heart attack and stroke prevention.
Diabetes Risk Assessment
Caristo's portfolio of imaging-based and AI-assisted platforms can also be applied to aid the prediction and diagnosis of diabetes, alongside heart attack and stroke.
Coronary Inflammation
Their patented FAI-Scoreu2122 is a unique and validated biomarker that quantifies coronary inflammation, a crucial risk factor for heart attacks often missed by traditional CCTA. It is the only commercially available tool that can detect and measure coronary inflammation on routine CCTA.
Plaque Analysis
CaRi-Plaqueu2122 offers quantitative characterization of coronary plaque, providing detailed insights into plaque composition (calcified, non-calcified, low-density non-calcified), total plaque volume, plaque burden, maximum stenosis, and remodeling index.
AI-Assisted Imaging & CCTA Analysis
Caristo's core technology leverages artificial intelligence to analyze routine CCTA images, transforming them into a powerful prevention tool. Their cloud-based Software as a Service (SaaS) platform ensures seamless workflow, secure data transfer, and intuitive, actionable reports.
Physician Tip

For physicians, Caristo Diagnostics offers a paradigm shift in cardiovascular care by enabling earlier and more precise risk stratification. The CaRi-Heartu00ae and CaRi-Plaqueu2122 analyses provide critical insights into coronary inflammation and plaque characteristics that are not visible with standard CCTA interpretation alone. This allows for proactive intervention, personalized treatment strategies (including lifestyle modifications and targeted medications), and improved patient outcomes, particularly for those with non-obstructive CAD who are often misclassified as low risk. The rapid turnaround of reports (typically within 48 hours) facilitates timely clinical decision-making.

Caristo's CaRi-Heartu00ae platform is a cloud-based Software as a Service (SaaS) medical device designed for seamless integration into existing clinical workflows. It accepts de-identified CCTA scans from most scanner models or PACS systems via secure and anonymized data transfer. The analysis results are delivered to healthcare professionals as intuitive, actionable reports in either DICOM-conformant files or PDF format. For users of CaRi-Plaqueu2122, there is a seamless adoption pathway for CaRi-Heartu00ae once it receives full FDA clearance in the US.

Products by Caristo Diagnostics

1 product in the directory

CaRi-Plaque
Caristo Diagnostics
Cardiology AI
CaRi-Plaque is an FDA-cleared, AI-assisted image analysis application by Caristo Diagnostics for non-invasive analysis of coronary anatomy and pathology from routine coronary CT angiography (CCTA) scans, determining the presence, extent, and severity of coronary plaques and quantifying luminal stenosis.

What the Web Says

Caristo Diagnostics is an Oxford, UK-based company specializing in AI-powered cardiovascular imaging and diagnostics. Their flagship product, CaRi-Heart, utilizes advanced AI algorithms on routine cardiac CT scans to visualize and quantify coronary inflammation, a key indicator of heart attack risk. The company has received positive attention for its innovative approach to preventative cardiac care, with studies suggesting its technology could significantly reduce cardiac deaths and costs.

Overall: Positive

Strengths

  • AI-powered technology for early heart attack prediction (up to 10 years in advance)
  • Identifies coronary inflammation, a previously invisible root cause of heart disease
  • Cloud-based software, agnostic to the type of scanner
  • Clinically validated and supported by studies published in leading medical journals
  • Potential to reduce cardiac deaths and healthcare costs
  • FDA 510(k) clearance for CaRi-Plaque for coronary plaque detection

Limitations

  • CaRi-Heart is currently for investigational use only in the United States, though CaRi-Plaque has FDA clearance
  • Limited information on employer reviews from major platforms like Glassdoor or Indeed
  • Some Reddit discussions express concerns about the cost and potential for insurance companies to use such technology to deny claims or increase premiums
  • Early evidence about clinical utility of CaRi-Heart Risk is underdeveloped and has limitations in terms of risk of bias and applicability to UK clinical practice
  • Lack of information on how treatment could change as a result of using CaRi-Heart and whether any changes would improve outcomes for patients

Based on reviews from: Caristo Diagnostics Official Website, Medical Device Network, Indeed.com, PMC (PubMed Central), BioWorld, Newsweek, AuntMinnie, PR Newswire, Reddit, Scam Detector

Last updated: 2026-07-18

Videos

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Press & Coverage

PR Newswire
Caristo Diagnostics to Highlight New Findings Reinforcing the Science of Its Coronary Inflammation and Plaque Analysis Technologies at SCCT 2026
Caristo Diagnostics announced that new evidence from the University of Oxford-led ORFAN registry will be presented at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in San Diego on July 9-12, 2026. The presentations will include three of the six abstracts nominated for the SCCT Young Investigator Award.
2026-07
Caristo Diagnostics
Caristo Diagnostics Selected by World Economic Forum as a 2026 Technology Pioneer
Caristo Diagnostics was named a 2026 Technology Pioneer by the World Economic Forum in June 2026. This recognition highlights the company's leadership in AI technologies for cardiovascular disease.
2026-06
Caristo Diagnostics
Aetna to cover Caristo's AI-powered CaRi-Plaque analysis nationwide, alongside other major insurers
Aetna has implemented nationwide coverage for Caristo's AI-powered CaRi-Plaqueu2122 analysis software, joining Cigna, Humana, and UnitedHealthcare. This expands access to advanced coronary plaque analysis technologies for millions of insured Americans.
2026-01
Caristo Diagnostics
Caristo Secures FDA Clearance, Ushering in a New Era of AI-Powered Heart Attack Prevention
Caristo Diagnostics received U.S. Food and Drug Administration (FDA) 510(k) clearance for its CaRi-Plaqueu2122 technology in March 2025. This AI-assisted image analysis application aids in the diagnosis of coronary artery disease.
2025-03
Diagnostic and Interventional Cardiology
Landmark Clinical Study in The Lancet Finds New AI Technology Can Predict Cardiac Events Due to Coronary Inflammation at Least 10 Years in Advance
A landmark clinical study published in The Lancet in June 2024 supports Caristo's CaRi-Heart AI technology's ability to quantify coronary artery inflammation and accurately predict cardiac events. The study demonstrated the prognostic value of Fat Attenuation Index (FAI) Score measurements in identifying cardiovascular risk up to 10 years in advance.
2024-06
Caristo Diagnostics
Newsweek Selects Caristo Diagnostics as One of World's Best Digital Health Companies
Caristo Diagnostics was named by Newsweek as one of the World's Best Digital Health Companies in April 2024.
2024-04
PR Newswire
Caristo Diagnostics Completes Series A Financing and Welcomes New CEO to Advance Ground-Breaking AI Technology for Cardiac Disease Detection
Caristo Diagnostics secured an additional u00a313 million (US$16.3 million) to conclude its Series A financing round in April 2023, bringing total venture capital investment to over u00a323 million. The funding will be used to advance its CaRi-Heartu00ae technology into standards of cardiac care globally.
2023-04
Oxford Science Enterprises
CEO Spotlight: Frank Cheng, Caristo Diagnostics
Frank Cheng joined Caristo Diagnostics as CEO in early 2023, with a focus on expanding the company's reach into the United States market. Caristo's technology aims to predict heart attacks years in advance.
2023-06

Frequently Asked Questions

Caristo Diagnostics offers CaRi-Heartu00ae and CaRi-Plaqueu2122 technologies. CaRi-Heart is an AI-enabled imaging solution that quantifies coronary inflammation and characterizes plaque, generating an individualized risk score for fatal cardiac events. CaRi-Plaque is an AI-assisted image analysis application that provides non-invasive characterization of coronary anatomy and pathology, including the presence, extent, and severity of coronary plaques and luminal stenosis.
Caristo's AI technology applies advanced algorithms to routine Coronary Computed Tomography Angiography (CCTA) scans to visualize and quantify coronary inflammation, a key driver of many fatal heart attacks and strokes. This allows for the identification of high-risk patients, even those with non-obstructive coronary artery disease, enabling earlier intervention and personalized prevention strategies.
Caristo's approach emphasizes that coronary inflammation is a crucial, often unseen, risk factor for heart attacks, even in patients without significant plaque buildup. Their FAI-Scoreu2122 (Fat Attenuation Index) is a patented biomarker that measures coronary inflammation, while CaRi-Plaque provides detailed quantification and characterization of plaque composition and burden.
CaRi-Heart is regulatory cleared for clinical use in the UK, European Union, and Australia, and is currently available for research use only in the U.S. CaRi-Plaque has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is also regulatory cleared for use in the UK, EU, and Australia.
Yes, Caristo Diagnostics is developing AI algorithms to deliver early risk prediction for diabetes. Their FatHealth technology aims to detect fat tissue inflammation from CT scans, which is a reliable indicator of diabetes-related cardiometabolic risk.
Specific pricing for CaRi-Heart analysis varies by geography and is offered through hospitals and healthcare professionals. For CaRi-Plaque, the Centers for Medicare & Medicaid Services (CMS) has established specific reimbursement pathways and payment rates for 2026 under new Category I CPT codes for both hospital outpatient and physician office settings.
Caristo Diagnostics, a spin-out from the University of Oxford, is a global leader in AI-powered heart disease detection, backed by significant venture capital investment. They have established partnerships with major healthcare providers and insurers in the UK, EU, Australia, and are expanding their presence in the U.S. market.

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