Caristo Diagnostics
Caristo Diagnostics is an Oxford-based biotech that provides AI-powered diagnostic platforms for cardiovascular disease, analyzing routine CCTA scans to quantify coronary inflammation and predict fatal cardiac events up to 10 years in advance for hospitals and pharmaceutical companies.
- Company typePrivate
- Founded2018
- HeadquartersOxford, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Caristo Diagnostics does
Caristo Diagnostics is a privately held biotech company founded in 2018 as a spin-out from the University of Oxford, headquartered in Oxford with a US regional office in Stamford, Connecticut. The company develops AI-powered diagnostic platforms that analyze routine Coronary Computed Tomography Angiography (CCTA) scans to quantify previously invisible coronary inflammation via perivascular fat attenuation imaging and characterize plaque composition, generating individualized 8-year risk scores for fatal cardiac events. Its core products are the cloud-based CaRi-Heart SaaS medical device, the proprietary FAI-Score inflammation biomarker, the FDA-cleared CaRi-Plaque analysis module, and the composite CaRi-Heart Risk Score predictive model. The technology is grounded in over two decades of Oxford research and is validated across the ORFAN registry, which contains more than 135,000 patients and targets 250,000, with peer-reviewed publications in The Lancet, JACC, and European Heart Journal.
Caristo generates revenue through multiple streams. Hospitals and healthcare providers order CaRi-Heart analysis by uploading CCTA scans to the cloud platform and pay through subscription or per-analysis arrangements, with results delivered after human verification typically within 48 hours; this service is commercially available in the UK, Europe, and Australia. Following FDA 510(k) clearance of CaRi-Plaque in March 2025 and finalized Medicare reimbursement effective January 2026, the company is scaling US commercialization through hospital systems and cardiology practices. A second revenue stream is professional services contracts serving as worldwide imaging core lab for pharmaceutical clinical trials, currently including NewAmsterdam Pharma's REMBRANDT trial across 50 sites in 7 countries and Abcentra's FORTIFY trial across 40 sites in the US and Europe, where FAI-Score has been selected as a primary outcome measure. Additional channels include employer wellness programs, preventive/longevity clinics, and self-pay preventive screening services.
The company has raised over $30 million in venture capital from Oxford Science Enterprises, Longwall Venture Partners, BGF Ventures, Oxford Investment Consultants, and Oxford University Innovation, with a Series A of $16.3 million in April 2023. In 2026 the company installed a new senior executive team — CEO Stephen Deitsch (former CFO of OrganOx, $1.5 billion Terumo exit), CCO David Vort (former CCO of iRhythm Technologies, 2016 IPO), and CFO Chris Louk (Piper Sandler healthcare investment banking) — alongside continued scientific leadership from Oxford co-founders Charalambos Antoniades, Keith Channon, Stefan Neubauer, and Cheerag Shirodaria. The company was recognized as a 2026 World Economic Forum Technology Pioneer.
Caristo Diagnostics firmographics
Firmographics- Name
- Caristo Diagnostics
- Legal name
- Caristo Diagnostics Ltd.
- Website
- https://caristo.com
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Caristo Diagnostics is an Oxford-based biotech that provides AI-powered diagnostic platforms for cardiovascular disease, analyzing routine CCTA scans to quantify coronary inflammation and predict fatal cardiac events up to 10 years in advance for hospitals and pharmaceutical companies.
- Ownership category
- akta.pro rank
Caristo Diagnostics industry classification
Industry- Product category
- AI Cardiovascular Diagnostics Software
- NAICS
- Medical and Diagnostic Laboratories (62151), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Services-Medical Laboratories (8071), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Non-Invasive Cardiac Imaging (Echo/CT/MRI/Nuclear) (HLAKABAE)
- akta.pro secondary industries
- Imaging & Cardiac Safety Core Labs (ECOG/EEG/ECG) (HLAGAAAJ), Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management (HLACAOAI)
Keywords
Where Caristo Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Oxford
- HQ country
- United Kingdom
- HQ region
- Europe
Offices2 records
Markets served
Caristo Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure
Revenue model
- CaRi-Heart Analysis Services: Healthcare professionals and hospitals order CaRi-Heart analysis by sending CCTA scans to Caristo's cloud platform. The company charges per analysis or through subscription arrangements with hospital systems. Results are delivered after human verification, typically within 48 hours. Available in UK, Europe, and Australia commercially; research use only in US pending FDA clearance.
- CaRi-Plaque Analysis Services: FDA-cleared coronary plaque analysis service. Hospitals and clinics bill Medicare starting January 2026 following Medicare reimbursement finalization. Category I CPT code 75XX6 effective January 2026. Enables hospitals to generate revenue through insurance reimbursement while Caristo provides the analysis platform.
- Clinical Trial Imaging Core Lab Services: Caristo serves as worldwide imaging core lab for pharmaceutical clinical trials, providing coronary plaque and inflammation measurements. Engaged by NewAmsterdam Pharma for REMBRANDT trial (50 sites, 7 countries) and Abcentra for FORTIFY trial (40 sites, US and Europe). Generates revenue through professional services contracts with pharma/biotech companies.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | CaRi-Heart analysis pricing varies by geography and is available only through healthcare providers |
Go-to-market motion1 record
Distribution channels6 records
Marketing channels7 records
Caristo Diagnostics product offering
Product offeringCore offering
Caristo Diagnostics develops and sells CaRi-Heart®, a cloud-based SaaS medical device that applies AI algorithms to routine Coronary Computed Tomography Angiography (CCTA) scans to quantify coronary inflammation (FAI-Score), characterize plaque (CaRi-Plaque), and generate an individualized 8-year fatal cardiac event risk score. The company delivers results to hospitals, NHS trusts, and clinicians within 48 hours and additionally provides imaging core lab services to pharmaceutical companies conducting cardiovascular clinical trials.
Product overview
Caristo Diagnostics offers CaRi-Heart®, a unified AI-powered cardiovascular diagnostics platform comprising three integrated components: (1) FAI-Score™ for proprietary measurement of coronary inflammation from peri-vascular adipose tissue changes on CCTA scans, (2) CaRi-Plaque™ for FDA-cleared quantitative plaque characterization and stenosis assessment, and (3) CaRi-Heart Risk Score for composite 8-year fatal cardiac event prediction. The cloud-based SaaS platform processes routine CCTA images to transform cardiac imaging from diagnostic triage into preventive risk assessment, predicting heart attacks up to a decade in advance. Additional services include drug clinical trial support as worldwide imaging core lab for pharmaceutical partners (NewAmsterdam Pharma REMBRANDT, Abcentra FORTIFY trials), preventive screening programs for employers, and clinical research collaborations.
Differentiator
Problem solved
Functional benefit
Brands
- CaRi-Heart: AI-powered technology that quantifies coronary inflammation and characterizes plaque based on routine Coronary Computed Tomography Angiography (CCTA) to predict cardiac risk.
- CaRi-Plaque
- FAI-Score
Products and services
- CaRi-Heart® Platform Cloud-based SaaS medical device that applies AI algorithms to routine Coronary Computed Tomography Angiography (CCTA) scans to quantify coronary inflammation (FAI-Score), characterize plaque (CaRi-Plaque), and deliver an individualized 8-year fatal cardiac event risk score. Delivered to hospitals and healthcare professionals with results within 48 hours; commercially available in UK, Europe, and Australia, with CaRi-Plaque FDA-cleared in the US.
- FAI-Score™
Quantifiable outcome
- High FAI-Score showed 20x increased risk of cardiac mortality
- +6 more outcomes
Companies that use Caristo Diagnostics
Customer profileNamed customers13 records
Segments6 records
Ideal customer profiles4 records
Caristo Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability4 records
Feature4 records
Caristo Diagnostics partnerships and signals
Strategic signalPartnerships
Eleven partnerships are on record, tiered core and minor.
- NCH Rooney Heart Institute (Naples Comprehensive Health)coreNCH Rooney Heart Institute became first US hospital to deploy both CaRi-Plaque and CaRi-Heart technologies. Collaboration positions NCH at forefront of preventive cardiology. NCH also launching self-pay preventive heart health service for proactive cardiac care. Cardiologists presenting at AHA 2025 Scientific Sessions.
- NewAmsterdam PharmacoreCaristo appointed as worldwide imaging core lab for NewAmsterdam Pharma's REMBRANDT clinical trial assessing obicetrapib and ezetimibe on coronary plaque and inflammation. Trial involves 50 sites across 7 countries (US, Poland, UK, Czech Republic, Hungary, Italy, Spain), measuring changes over 18 months. Primary endpoint is percent change in noncalcified plaque volume; secondary endpoints include FAI-Score changes.
- BiographcoreBiograph, world's most advanced preventive health and diagnostics clinic, partnered with Caristo as first US clinic to study CaRi-Heart technology for early detection of coronary artery disease in asymptomatic patients. Initial study phase enrolls 100 Black Tier members beginning October 2025. Study evaluates both CaRi-Heart and CaRi-Plaque technologies.
- AbcentracoreCaristo selected as worldwide imaging core lab for Abcentra's FORTIFY Phase 2b clinical trial evaluating orticumab in patients with cardiovascular disease. FAI-Score selected as primary outcome measure. Trial enrolls 240 adults at 40 sites in US and Europe. Caristo supports patient selection through elevated coronary inflammation measurement.
- Surrey Cardiovascular Clinic (SCVC)coreSCVC partnered with Caristo to offer CaRi-Heart AI technology as central part of employee wellness initiative for UK employers. Partnership includes imaging provider VCL Surrey. SCVC provides comprehensive health screening packages including CaRi-Heart analysis for early heart attack prediction.
- HeartX Cardiovascular AcceleratorminorCaristo selected by HeartX cardiovascular accelerator for its 2024 program, receiving support for clinical trials and pilot projects in Arkansas and beyond alongside other cardiovascular startups including Haermonics, MultiplAI Health, and Peerbridge Health.
- Agepha PharmaminorAgepha Pharma, maker of LODOCO (FDA-approved anti-inflammatory cardiovascular treatment), partnered with Caristo to improve awareness and clinical education about the central role of inflammation in coronary artery disease. Collaboration focuses on educating clinicians about targeting inflammation as a treatment pathway.
- NHS EnglandcoreNHS England supported pilot deploying CaRi-Heart technology in five NHS trusts: University Hospitals of Leicester, Liverpool Heart and Chest, Milton Keynes University Hospital, Oxford University Hospitals, and Royal Wolverhampton NHS Trust. Patients in Rapid Access Chest Pain Clinics receive enhanced CCTA analysis.
- University of OxfordcoreCaristo founded in 2018 as spin-out from University of Oxford. Co-founders (Charalambos Antoniades, Keith Channon, Stefan Neubauer, Cheerag Shirodaria) are Oxford faculty. ORFAN registry led by Oxford. Ongoing collaboration on research and clinical validation studies.
- SimonMed ImagingcoreLargest independent radiology practice in the United States planning collaboration with Caristo. Founder and CEO Dr. John Simon stated commitment to prevent hundreds of thousands of deaths through cardiac CT combined with Caristo's AI technologies.
- MedpaceminorJoint webinar partnership with Medpace on advancing ASCVD trials through innovative imaging endpoints. Medpace is a contract research organization (CRO) specializing in cardiovascular clinical trials.
Scale indicators14 records
Recent moves7 records
Expansion highlights6 records
Caristo Diagnostics competitors and assessment
Company assessmentDirect peers
- HeartFlow: HeartFlow applies AI to CCTA scans to compute FFR-CT for non-invasive assessment of coronary artery disease. It is the most direct competitor to Caristo in CCTA-AI, with an established US commercial footprint and substantially more capital raised, although its core focus is hemodynamic/ischemic assessment rather than inflammation.
- Cleerly Health: Cleerly is a venture-backed CCTA-AI platform that characterizes coronary plaque and stenosis to predict heart attack risk — overlapping directly with Caristo's CaRi-Plaque product. Both target US hospital systems and cardiology practices with AI-augmented CCTA reporting.
- Elucid Bioimaging: Elucid offers FDA-cleared AI software (vascuCAP) for quantitative plaque characterization from CCTA, including composition and stenosis. It competes most directly with CaRi-Plaque in the US and Europe.
Emerging players
- Artrya: Australia-based AI cardiac imaging startup applying deep learning to CCTA for plaque and risk assessment. Artrya targets a similar cardiology customer base as Caristo and has overlapping geographic presence in Australia and the UK.
- Anumana: Anumana is an AI-driven ECG-based cardiac diagnostics company spun out from Mayo Clinic. It is an emerging competitor in AI cardiovascular diagnostics, addressing risk detection via a different modality (ECG) but targeting the same cardiology prescribers and pharma services customers.
Broad incumbents
- GE HealthCare: GE HealthCare manufactures CT scanners and broad cardiac imaging AI tools integrated into its imaging platforms. As a broad incumbent, it competes indirectly by bundling AI features into PACS and scanner ecosystems used by the same hospital customers Caristo targets.
- Siemens Healthineers: Siemens Healthineers offers cardiac CT scanners and AI-based post-processing (e.g., syngo.via). It is a broad incumbent that could integrate competing inflammation or plaque analytics directly into its scanner and PACS workflow.
- Philips: Philips provides cardiovascular imaging and AI-enhanced analysis tools (IntelliSpace Portal). It is a broad incumbent competing for the same hospital cardiology budgets and could leverage its installed base to deploy competing CCTA-AI.
Others
- Medpace: Medpace is a CRO with a strong cardiovascular trial franchise that already co-hosts webinars with Caristo. It is a channel/ecosystem partner rather than a competitor, but as a vertically integrated CRO it could internalize imaging core lab capabilities over time.
- Clario: Clario is a leading clinical trial imaging core lab and eCOA provider for cardiovascular trials. It competes with Caristo for pharma imaging core lab mandates (e.g., FAI-Score / plaque quantification in CV outcome trials).
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Caristo Diagnostics social profiles
Digital presenceCaristo Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Caristo Diagnostics leadership team
Management profileNumber of profiles
Profiles14 records
Caristo Diagnostics funding detail
Funding detailFunding overview
Funding rounds4 records
Investors6 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Caristo Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Caristo Diagnostics
What does Caristo Diagnostics do?
Caristo Diagnostics develops and sells CaRi-Heart®, a cloud-based SaaS medical device that applies AI algorithms to routine Coronary Computed Tomography Angiography (CCTA) scans to quantify coronary inflammation (FAI-Score), characterize plaque (CaRi-Plaque), and generate an individualized 8-year fatal cardiac event risk score. The company delivers results to hospitals, NHS trusts, and clinicians within 48 hours and additionally provides imaging core lab services to pharmaceutical companies conducting cardiovascular clinical trials.
Is Caristo Diagnostics a public or private company?
Caristo Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Caristo Diagnostics founded?
Caristo Diagnostics was founded in 2018. It employs 11 to 50 people.
Where is Caristo Diagnostics based?
Caristo Diagnostics is headquartered in Oxford, United Kingdom, in the Europe region.
How does Caristo Diagnostics make money?
Three revenue lines are on record. CaRi-Heart Analysis Services are the primary driver. The others are caRi-Plaque Analysis Services and clinical Trial Imaging Core Lab Services.
Who are Caristo Diagnostics's main competitors?
Direct peers on record are HeartFlow, Cleerly Health and Elucid Bioimaging. Emerging players are Artrya and Anumana. Broad incumbents are GE HealthCare, Siemens Healthineers and Philips. Others are Medpace and Clario.
Does Caristo Diagnostics have an API?
No public API is recorded for Caristo Diagnostics.
What industry is Caristo Diagnostics in?
Caristo Diagnostics's product category is AI Cardiovascular Diagnostics Software. Its primary akta.pro industry code is HLAKABAE, Non-Invasive Cardiac Imaging (Echo/CT/MRI/Nuclear), with a secondary code of HLAGAAAJ, Imaging & Cardiac Safety Core Labs (ECOG/EEG/ECG). Its NAICS code is 62151 and its SIC code is 8071.