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Cardiovascular imaging

Cleerly LABS

Cleerly

Uses coronary CT angiography to quantify and characterize coronary plaque and stenosis.

Designed for

Qualified clinician

Care setting

Hospital and cardiac imaging center

Specialty

Cardiology, Cardiac radiology

Public evidence assessedReviewed August 31, 2026

Our assessment

Bottom line

Cleerly LABS has substantial evidence for quantitative CCTA analysis and for changing physician interpretation or management. A management change is not automatically a patient benefit, so repeatability, clinical thresholds, downstream testing, treatment, and outcomes remain central.

Based on public sources. RIR did not independently test this product. This is not an endorsement or recommendation.

What the evidence supports

Reviewed sources establish cleared AI-supported CCTA processing for plaque, vessel, and stenosis measurements.

What remains uncertain

The effect of AI-QCT-guided management on patient outcomes and transportability across local protocols remains under study.

How it was studied

Cleerly LABS has been compared with expert readers, quantitative coronary angiography, fractional flow reserve, and other references. In the prospective multicenter CERTAIN crossover study, 750 patients were evaluated for changes in diagnostic certainty and management after AI quantitative CCTA information.

Product facts

Intended use
Provide quantitative coronary anatomy and plaque analysis from eligible CCTA studies to support clinician assessment.
Represented version
Cleerly LABS represented by FDA 510(k) K242338; deployed version requires confirmation
Regulatory context
The represented Cleerly LABS version is FDA-cleared under K242338. Separate modules and later revisions may have different scope.

Sources reviewed

3 public sources represented in this evidence profile.

Prospective multicenter CERTAIN studyPrimary evidenceFDA 510(k) summary K242338RegulatoryCleerly product overviewOfficial product
For clinical and investment reviewEvidence context and questions for deeper review

Evidence source base

Published and regulatory evidence with company funding or author relationships in several studies. Independent replication and local repeatability are important.

Important limitation

Agreement and decision change do not establish that every changed decision improves outcomes. Plaque quantification also needs repeatability and stability across scanners, protocols, and software versions.

Questions to ask

  1. 01Which analysis modules are included in the order?
  2. 02How is measurement agreement monitored locally?
  3. 03What management changes are supported by prospective evidence?
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