Caristo Diagnostics vs Elucid
Two vendors that both refuse the Hounsfield threshold shortcut, measuring what conventional plaque volume misses from different angles. Caristo measures inflammation: its FAI-Score quantifies the perivascular fat attenuation gradient, and in the Lancet published ORFAN registry, patients with minimal plaque and zero calcium but the highest inflammation carried roughly 9.5 to 11 times the cardiac mortality risk. Elucid measures tissue composition: PlaqueIQ classifies plaque against carotid endarterectomy histopathology co registered to CTA, interpreting spatial tissue distribution where attenuation values overlap, and it names lipid rich necrotic core as its target. Both earn an A on model transparency for publishing a checkable mechanism, which makes this a genuine question of which risk signal you want rather than which vendor is more credible. The US split decides availability: Elucid's core product is FDA cleared with Medicare contractor and commercial coverage, while Caristo's inflammation product is pending FDA clearance and holds only a Category III tracking code. If your failure mode is the clean looking scan and you practice where FAI is cleared, start with Caristo. If your failure mode is confident plaque composition with resolved US coverage, start with Elucid, noting its analyst segmentation step is not fully autonomous.
- 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, biology Elucid's plaque composition analysis does not measure.
- A published causal chain from biology to risk score, graded A on model transparency, matching Elucid's own A for its histology co registration mechanism, so both vendors let you check the method rather than trust an accuracy claim.
- Independent external validation: ORFAN validated the prognostic algorithm in an NHS population in routine clinical care, the specific generalisation test most imaging AI never faces.
- Ground truth against tissue: PlaqueIQ's networks were trained on carotid endarterectomy histopathology co registered to CTA, classifying plaque against actual tissue rather than Hounsfield thresholds, marketed as CT Virtual Histology.
- US reimbursement is resolved for the core product: four of seven Medicare contractors extended coverage from November 2024 and United Healthcare aligned from October 2025, where Caristo's differentiating FAI-Score holds only a Category III tracking code in the US.
- Lipid rich necrotic core is the target: spatial interpretation across adjacent voxels where attenuation values overlap between tissue types, extended to carotid stroke risk with an October 2025 launch.
Side-by-Side
| Axis | C Caristo Diagnostics |
E Elucid |
|---|---|---|
| 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 model transparency for publishing a checkable mechanism rather than a proprietary accuracy claim, and both measure something conventional plaque volume misses, Caristo inflammation and Elucid tissue composition. The US regulatory split is the decisive fact: Elucid's PlaqueIQ is FDA cleared with real Medicare contractor and commercial coverage, while Caristo's FAI-Score is pending FDA clearance and holds a Category III tracking code without established payment; Caristo's US cleared product is CaRi-Plaque. Two workflow cautions: Elucid is not fully autonomous, trained analysts segment the data before classification, and its FFRCT product is pending clearance and not available; Caristo's cloud pipeline does not disclose the extent of any quality control step. ORFAN results should be read from the published study. Neither vendor publishes pricing or data residency terms.