Caristo Diagnostics vs Cleerly (2026)
Both read the same coronary CT angiogram and look at different things in it. Cleerly quantifies and characterizes plaque and estimates ischemia, and its ISCHEMIA product was validated in the prospective, multicenter CREDENCE trial against invasive FFR. Caristo's CaRi-Heart measures the inflammation around the coronary arteries and turns it into a 10 year cardiac mortality risk estimate; it received FDA De Novo authorization in July 2026 and launches in the US from the third quarter. Caristo also sells CaRi-Plaque for plaque and stenosis. Cleerly's products are billed under Category I codes, while CaRi-Heart has Category III codes. If you want plaque and ischemia with payer coverage in place, start with Cleerly. If you want inflammation risk, including in patients without obstructive disease, start with Caristo.
- Inflammation is the question: CaRi-Heart quantifies coronary inflammation from the routine scan and estimates 10 year cardiac mortality risk.
- Your patients have no obstructive disease: ORFAN and CRISP-CT, published in The Lancet, link higher inflammation scores to cardiac events in that group.
- You want the operating limits in writing: the Instructions for Use are published openly, with cautions and age and imaging limits.
- Ischemia is the question: Cleerly ISCHEMIA was validated in the prospective, multicenter CREDENCE trial against invasive FFR, and K231335 reports its figures with counts.
- You want the security reports without asking: the public trust center offers SOC 2 Type 2 and HITRUST reports for download.
- Reimbursement is in place: Category I CPT codes cover plaque analysis and ISCHEMIA, with Medicare contractor and commercial coverage.
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
Select any grade to read the note behind it.
Each vendor in one paragraph
Written to be quoted whole. Each paragraph opens the AI Health Index profile of the vendor: what the product is, who buys it and what it does.
Caristo Diagnostics, an Oxford spinout, measures coronary inflammation from the same routine coronary CT angiogram used to assess plaque. Inflammation changes the fat around the coronary arteries in a way CT can detect; CaRi-Heart uses AI to quantify it as the FAI-Score and to estimate 10 year cardiac mortality risk (the CaRi-Heart Risk score).
Source: AI Health Index, September 2026
Cleerly applies AI to coronary CT angiography to quantify and characterize atherosclerotic plaque and estimate ischemia without an invasive test. Cleerly Labs, web based analysis cleared in 2020, measures plaque volume, composition, length and location and stenosis on CCTA from any scanner; Cleerly ISCHEMIA, cleared in 2023 (K231335), estimates vessel level ischemia as a diagnostic aid; Cleerly COMPARE tracks change between scans.
Source: AI Health Index, September 2026
Questions buyers ask
How do Caristo Diagnostics and Cleerly work with the EHR?
CaRi-Plaque receives CT images from the hospital's PACS by secure transmittal (DICOM), and Caristo returns a report to the healthcare professional, with an optional primary care summary report; turnaround is set by contract and can be delayed.
Cleerly operates as a CCTA analysis service that returns a physician report, sitting in the cardiac imaging and reporting pathway rather than integrating deeply with the EHR. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
How are Caristo Diagnostics and Cleerly priced and sold?
In Caristo Diagnostics' case, the AMA assigned Category III CPT codes 0992T and 0993T for CaRi-Heart from January 2026; Category III codes track emerging technology and carry no set national payment, so coverage is decided payer by payer. CaRi-Plaque falls under the Category I code for AI plaque analysis.
Cleerly publishes billing guidelines, coverage pages and a payer policy lookup tool: AI plaque analysis of coronary CT carries Category I CPT code 75577 from January 2026, ISCHEMIA is billable under Category I code 75580, and Medicare contractor and commercial payer policies are reported to cover more than 86 million lives. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
Which settings and specialties do Caristo Diagnostics and Cleerly cover?
With Caristo Diagnostics, the site also markets preventive screening, drug trial endpoints and intervention planning, which that validation does not cover.
Cleerly Labs analyzes CCTA from any CT scanner for patients with known or suspected coronary artery disease, and ISCHEMIA estimates vessel level ischemia as a diagnostic aid; COMPARE tracks change between scans. ISCHEMIA was validated in stable patients referred for non-emergent invasive angiography at 23 centers in and outside the US, with results reported for both. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
What evidence is published for Caristo Diagnostics and Cleerly?
The research comes from the Oxford group that founded Caristo, so it is multicenter and peer reviewed rather than independent of the company. What is not yet shown is that acting on the score improves outcomes.
With Cleerly, a post-hoc analysis of the PACIFIC trial compared it with FFRCT, PET and SPECT against invasive FFR, and the international CONFIRM2 registry links quantified plaque burden to risk. The company's claims that ISCHEMIA was more accurate than FFRCT and stress testing and was the only non-invasive ischemia test prognostic of later events come from its own analyses of CREDENCE and PACIFIC. From the AI Health Index, drawn from each vendor's own published materials and the regulatory record, verified September 27, 2026. No vendor pays for placement.
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.
Caristo's evidence for the inflammation score comes from the Oxford group that founded the company, and the US indication and conditions of its De Novo authorization are not yet published. Payer codes and coverage describe what a provider recovers, not what either vendor charges, and neither publishes a price. Cleerly COMPARE is marketed without an identified clearance.