Caristo Diagnostics vs Cleerly (2026)
Two strong evidence records pointed at different biology. Cleerly quantifies plaque and has built the payment machinery around it: cleared since 2020, its analysis underpins Category I CPT codes and commercial policies reported to span more than 86 million covered lives, backed by the CREDENCE, PACIFIC, and CONFIRM2 registries. Caristo measures inflammation, and its evidence is unusually independent: in the Lancet published ORFAN registry, patients with minimal plaque and zero calcium but the highest coronary inflammation carried roughly 9.5 to 11 times the cardiac mortality risk, risk that plaque assessment alone declares absent. Both earn an A on evidence, but note the source difference, Caristo's is Oxford led and externally validated in the NHS, while much of Cleerly's foundational trial data was generated through its own clinical network. The US catch sits on Caristo's side: its inflammation product is pending FDA clearance and holds only a Category III tracking code, while its US cleared CaRi-Plaque competes on plaque, not inflammation. If your failure mode is the patient whose scan looks clean and you practice where FAI is cleared, start with Caristo. If your failure mode is broadly reimbursed US plaque quantification today, start with Cleerly.
- The clean scan is your blind spot: in the Lancet published ORFAN registry, patients with minimal plaque and zero calcium but high coronary inflammation showed roughly 9.5 to 11 times the cardiac mortality risk, a signal plaque quantification does not capture.
- Independent, externally validated evidence: ORFAN validated the prognostic algorithm in an NHS population and CRISP-CT established incremental value beyond traditional risk factors, both graded A on clinical evidence, where Cleerly's foundational trial data was substantially generated by its own clinical network.
- A published causal chain: the biology from inflammation to perivascular fat attenuation gradient to risk score is described in peer reviewed literature, graded A on model transparency against Cleerly's B.
- Coverage breadth today: Cleerly's technology underpins Category I CPT codes, multiple Medicare Administrative Contractor determinations, and commercial payer policies reported at more than 86 million covered lives, where Caristo's inflammation product holds only a Category III tracking code in the US.
- US reimbursement is resolved, not pending: Cleerly's plaque analysis sits in the established Category I pathway across the whole US, where Caristo's differentiating FAI-Score is pending FDA clearance for US clinical use.
- A validated ischemia estimate too: Cleerly ISCHEMIA derives a machine learning estimate of vessel level ischemia from the same scan, extending beyond the plaque and inflammation split this pairing turns on.
This comparison is published by AI Health Index, an independent research platform that compares healthcare AI vendors objectively. Caristo Diagnostics and Cleerly are each graded against the same capability taxonomy, from each vendor's own public materials and the regulatory record, under the AI Health Index verification standard. No vendor pays for placement, and no vendor has reviewed this page. How this evidence is graded
Plain facts
| Fact | Caristo Diagnostics | Cleerly |
|---|---|---|
| Primary category | Radiology & Imaging AI | Radiology & Imaging AI |
| Founded | Not recorded | 2017 |
| Headquarters | Oxford, England, United Kingdom | Denver, Colorado, United States |
| Website | caristo.com | cleerlyhealth.com |
Side by Side
Each record in one paragraph
Written to be quoted whole. Each paragraph states what the AI Health Index verified about the vendor, with the caveats attached. Generated from this pair’s live capability grades, so it moves when a grade moves.
The AI Health Index awards Caristo Diagnostics its top capability grade on several axes, including AI Centrality, Model and Technology Transparency and Clinical and Operational Evidence. Set against Cleerly, Caristo Diagnostics grades higher on Model and Technology Transparency and Deployment Model and Data Residency. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
The AI Health Index awards Cleerly its top capability grade on several axes, including AI Centrality, Clinical and Operational Evidence and Security Certifications and Trust Center. Set against Caristo Diagnostics, Cleerly grades higher on several axes, including HIPAA and BAA Posture, Security Certifications and Trust Center and Commercial Transparency. Grades reflect evidence the AI Health Index could verify at the last review, so a low grade records disclosure the vendor has not published rather than a capability it has been shown to lack.
Source: AI Health Index, July 2026
Questions buyers ask
Should we choose Caristo Diagnostics or Cleerly?
On the axes where the AI Health Index separates them, Caristo Diagnostics grades higher on Model and Technology Transparency and Deployment Model and Data Residency, and Cleerly grades higher on several axes, including HIPAA and BAA Posture, Security Certifications and Trust Center and Commercial Transparency. Cleerly leads on the greater share of scored axes, but the split means the decision turns on which constraint is binding rather than on an overall winner.
Where do Caristo Diagnostics and Cleerly differ most?
The widest separation the AI Health Index records between Caristo Diagnostics and Cleerly is on Model and Technology Transparency, where Caristo Diagnostics grades A and Cleerly grades B. That axis sits in the AI Capability group, so it should carry the most weight for a buyer whose binding constraint is how much of the work the model itself is trusted to do.
Where do Caristo Diagnostics and Cleerly grade the same?
The AI Health Index grades Caristo Diagnostics and Cleerly the same on several axes, including AI Centrality, Autonomy and Oversight Model and Model Supply Chain Disclosure. Neither holds an advantage the index can evidence on those axes, so they should not carry weight in a selection between these two.
Related comparisons
Other published head to head assessments involving these vendors or their closest peers. The full set for this category is on the Clinical Decision Support page.
Both grade A on AI centrality and on clinical evidence, from different evidence types: Caristo's is the independent Oxford led ORFAN and CRISP-CT work, and Cleerly's is the CREDENCE, PACIFIC, and CONFIRM2 registries, much of it generated through the company's own clinical network, which buyers should weigh.
The decisive US fact is regulatory: Cleerly's plaque analysis is cleared and broadly reimbursed under Category I, while Caristo's inflammation FAI-Score is pending FDA clearance and holds a Category III tracking code without established payment. Caristo's US cleared product is CaRi-Plaque, which competes with Cleerly on plaque quantification, not inflammation. ORFAN and CRISP-CT results should be read from the published studies. Neither vendor publishes pricing or data residency terms.