Caristo Diagnostics vs Cleerly
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.
Side-by-Side
| Axis | C Caristo Diagnostics |
C Cleerly |
|---|---|---|
| AI Centrality | ||
| Autonomy and Oversight Model | ||
| Model and Technology Transparency | ||
| Clinical and Operational Evidence | ||
| AI Safety and PHI Stewardship | ||
| HIPAA and BAA Posture | ||
| Security Certifications and Trust Center | ||
| FDA and Regulatory Status | ||
| AI Governance and Bias Disclosure | ||
| EHR and Interoperability Depth | ||
| Deployment Model and Data Residency | ||
| Commercial Transparency | ||
| Setting and Specialty Coverage |
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.