Caristo Diagnostics
Oxford spinout measuring coronary INFLAMMATION rather than plaque, from the same routine coronary CT angiography scan. This is what separates it from every other vendor in the cardiovascular CT lane. Coronary inflammation inhibits lipid accumulation in adjacent fat cells, producing a measurable gradient in the perivascular adipose tissue surrounding the artery, and the CaRi-Heart FAI-Score quantifies that gradient as a Fat Attenuation Index. The clinical significance is that it detects risk in patients who look clean on conventional assessment: in the Oxford led ORFAN registry, among patients with no or minimal plaque and zero calcium at CCTA, those with the highest coronary inflammation showed roughly 9.5 to 11 times the cardiac mortality risk and around 5 times the major adverse cardiac event risk compared with those with minimal inflammation. The company operates two distinct products with DIFFERENT regulatory standing, and buyers must not conflate them. CaRi-Plaque, for plaque and stenosis quantification, received FDA 510(k) clearance in March 2025 and sits in the same competitive set as Cleerly, Elucid, HeartFlow and Artrya. CaRi-Heart FAI-Score, the inflammation product and the actual differentiator, is regulatory cleared in the UK, EU and Australia but remains PENDING FDA clearance for US clinical use, holding only a Category III CPT code approved by the AMA panel. A Category III code is an emerging technology tracking code and is not the Category I code with established payment that applies to automated plaque analysis. Evidence is unusually strong and independent: ORFAN was published in The Lancet as a multicentre longitudinal cohort externally validating the AI-Risk prognostic algorithm in an NHS population, the CRISP-CT study established incremental prognostic value of perivascular FAI beyond traditional risk factors, an ESC Congress 2025 late breaker reported FAI-Score predicting cardiac death beyond hsCRP, and a prospective trial NCT07220304 is registered. Cloud based deployment.
Capability Axes
The measurement is the product. Perivascular Fat Attenuation Index cannot be read off a scan by eye; it requires the algorithm to quantify an attenuation gradient in tissue surrounding the artery. The company describes CaRi-Heart as the only commercially available technology able to detect and measure coronary inflammation on routine cardiac CT. No hardware line, no services business, no platform that merely hosts other people's models.
Prognostic decision support rather than autonomous action. The system produces a CaRi-Heart Risk Score with colour coded visualisation and quantitative metrics for clinician interpretation, and the registered CARE-CCTA trial is explicitly designed to evaluate impact on clinical decision-making rather than to remove the clinician. Graded B rather than A because the extent of any technical or human quality control step in the cloud analysis pipeline is not disclosed, which is the same gap flagged on Elucid's analyst segmentation.
The underlying biology and the measurement mechanism are published in the peer reviewed literature rather than asserted as proprietary accuracy. Inflammation inhibits lipid accumulation in perivascular adipocytes, creating a three dimensional gradient in the aqueous versus lipid content of the surrounding fat, which is quantified as a perivascular attenuation gradient from the CCTA derived Fat Attenuation Index. The AI-Risk prognostic algorithm and its classification system are described and externally validated in published work. A reader can follow the causal chain from biology to measurement to risk score, which very few imaging vendors permit.
Among the strongest evidence bases in the imaging lane, and independent rather than vendor generated. ORFAN is a multicentre longitudinal cohort study published in The Lancet, conducted through the UK NHS in routine clinical care, which externally validated a previously trained AI-Risk algorithm in a new population, the specific test most imaging AI never faces. Its headline finding is clinically consequential: among patients with no or minimal plaque and zero calcium, the highest inflammation group showed roughly 9.5 to 11 times cardiac mortality risk and around 5 times MACE risk, meaning the tool finds risk that current plaque and calcium based assessment declares absent. CRISP-CT established incremental prognostic value beyond traditional risk factors, an ESC Congress 2025 late breaking session reported FAI-Score predicting cardiac death beyond hsCRP with post-mortem CT linked to histology, and CARE-CCTA (NCT07220304) is a registered prospective study. Research is Oxford led and published in independent venues.
Cloud based analysis of patient CT data, but no published detail located on PHI handling, retention, or whether customer scans contribute to model development.
No published BAA terms located. Note the company is UK headquartered with US operations in Stamford, Connecticut, so UK GDPR and US HIPAA obligations both apply and neither posture is documented publicly.
No third party security attestation such as ISO 27001, ISO 13485 or SOC 2 was retrieved at the time of review.
A SPLIT position that a buyer must get right, and the company states it plainly rather than blurring it, which is why this is B and not C. CaRi-Plaque received FDA 510(k) clearance in March 2025 for plaque and stenosis quantification and is available in the US. CaRi-Heart FAI-Score, the inflammation measurement that is the company's actual differentiator, is cleared in the UK, EU and Australia but remains PENDING FDA clearance and is therefore not available for US clinical use. Two US milestones in 2025 are sometimes reported together in a way that implies more than they do: the CaRi-Plaque clearance, and an AMA CPT Panel approved Category III code for CaRi-Heart. CATEGORY III IS AN EMERGING TECHNOLOGY TRACKING CODE WITH NO ESTABLISHED PAYMENT and must not be confused with the Category I code carrying roughly $950 per assessment that applies to automated plaque analysis from January 2026. A US buyer purchasing for the inflammation capability specifically is buying something not yet cleared here.
Better than the imaging lane norm, and for a structural reason rather than a stated policy. The ORFAN validation was conducted across the UK NHS in routine clinical care rather than in a curated cohort, which is a genuine test of generalisation to an unselected population, the same reasoning that earned Rayscape credit for its South African prevalence survey validation. Graded B rather than A because no demographic subgroup performance breakdown was located, and because a UK NHS population does not establish performance in a US population with different demographics and different CCTA practice patterns.
No named PACS, RIS or CT vendor integrations located at the time of review. The relevant integration surface for a cloud CCTA analysis service is the imaging stack, and no specific partners were disclosed in retrieved materials.
Explicitly a non-invasive cloud based solution analysing routine CCTA scans, requiring no additional imaging or change to acquisition protocol, which is a genuine adoption advantage since it works on scans hospitals already perform. Graded B rather than A because cloud-only implies scans leave the institution and no data residency terms were published, which matters given UK and US operations under different data regimes.
No pricing published and the reimbursement position is genuinely ambiguous for a US buyer. CaRi-Plaque qualifies for the established Category I automated plaque analysis pathway, but CaRi-Heart holds only a Category III code, which is a tracking code without established payment, so the revenue path for the differentiating product is unresolved in the US. Contrast Cleerly and Elucid, both indexed, where the plaque analysis reimbursement position is concrete.
Narrow by design: coronary artery disease risk assessment from CCTA, serving cardiology and cardiac imaging. Two products against one disease area. Graded on the same scale as index peers spanning multiple body systems, the same way Elucid was.
Pricing
Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.
| Entry Price | Pricing Basis | BAA Tier | Implementation | Source |
|---|---|---|---|---|
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Not published
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Undisclosed. Split reimbursement: CaRi-Plaque on established Category I plaque pathway; CaRi-Heart on Category III tracking code with no established payment. | — | — | Vendor Published |
No pricing published. The commercially decisive issue here is not licence cost but the split reimbursement position between the two products, and a US buyer must model them separately. CaRi-Plaque, FDA cleared March 2025, sits in the automated plaque analysis category that carries an established Category I CPT code with reimbursement reported at roughly $950 per assessment from 1 January 2026, the same pathway available to Cleerly, Elucid, HeartFlow and Artrya. CaRi-Heart FAI-Score, the coronary inflammation measurement that is the company's genuine differentiator, holds only an AMA CPT Panel approved Category III code. Category III codes track emerging technology and carry no established payment amount, with coverage determined case by case by payers. CaRi-Heart also remains pending FDA clearance for US clinical use while being cleared in the UK, EU and Australia. The practical consequence is that a US institution can buy and bill the commoditised half of this vendor's offering today, but the capability that makes it worth choosing over its competitors is neither cleared nor reliably payable in the US yet. Buyers outside the US face a different and more favourable calculation. Ask the vendor directly for the FDA submission timeline for CaRi-Heart and for any payer coverage secured under the Category III code.