Caristo Diagnostics vs Heartflow
These two measure different biology from the same coronary CT scan, so this is less either or than a question of which risk you are missing. Heartflow computes physiology: FFRCT estimates the functional significance of each lesion, supported by the ACC AHA Chest Pain Guideline and the largest evidence base in this index, more than 600 peer reviewed publications and 400,000 plus patients in clinical use. Caristo measures inflammation: its FAI Score quantifies the fat attenuation gradient in perivascular tissue, and in the Lancet published ORFAN registry, patients with no or minimal plaque and zero calcium but the highest coronary inflammation carried roughly 9.5 to 11 times the cardiac mortality risk of those with minimal inflammation, which is risk conventional assessment calls clean. The US regulatory asymmetry decides most purchases: Heartflow's platform is cleared and guideline embedded, while Caristo's inflammation product is cleared in the UK, EU, and Australia but remains pending FDA clearance for US clinical use, holding a Category III tracking code rather than an established payment code; its FDA cleared US product is CaRi-Plaque, which competes in plaque quantification, not inflammation. If your failure mode is lesion significance in symptomatic patients, start with Heartflow. If your failure mode is the patient whose scan looks clean, and you practice where FAI is cleared, start with Caristo.
- 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 and physiology tools do not measure.
- Independent evidence posture: ORFAN externally validated the prognostic algorithm in an NHS population, CRISP-CT established incremental value beyond traditional risk factors, and an ESC 2025 late breaker reported FAI Score predicting cardiac death beyond hsCRP.
- You practice in the UK, EU, or Australia: CaRi-Heart FAI Score is regulatory cleared in those markets today, and CaRi-Plaque holds FDA clearance in the US plaque quantification set.
- Guideline embedded physiology: FFRCT is supported by the ACC AHA Chest Pain Guideline, the recognition no competitor in the lane holds.
- Evidence maturity without rival: more than 600 peer reviewed publications and 400,000 plus patients in clinical use across landmark trials from SCOT HEART to the DECIDE registry.
- One platform across the pathway in cleared markets: stenosis detection, physiology, plaque quantification, and intervention planning under Heartflow One.
Side-by-Side
| Axis | C Caristo Diagnostics |
H Heartflow |
|---|---|---|
| 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 |
Publication and patient counts come from each vendor's own materials; ORFAN and CRISP-CT results should be read from the published studies. The regulatory split is the decisive fact: Caristo's inflammation product is pending FDA clearance for US clinical use and holds a Category III emerging technology code, a tracking code without established payment, while its US cleared product is plaque quantification. Heartflow's Plaque and RoadMap functions are cleared in the US and four other countries only, and Heartflow's own dossier describes FFRCT reimbursement as inadequate, a candid disclosure this index credits. Neither vendor publishes pricing.