Cleerly
Cleerly
Automated analysis of coronary CT angiography that quantifies stenosis and characterizes plaque by volume and composition rather than reporting stenosis severity alone.
At A Glance
- Manufacturer
- Cleerly
- Medical specialty
- Cardiology
- Clearance route
- 510(k)
- Year authorized
- 2019 onward
- Modality
- Coronary CT angiography
- Role in workflow
- Quantification
The argument behind plaque quantification is that percent stenosis is a poor predictor of which lesion causes an event. Composition and total burden carry information stenosis grading discards, and human readers cannot practically quantify either at scale.
Where It Is Used
- Coronary plaque burden quantification
- Non-calcified plaque characterization
- Serial assessment of plaque progression under therapy
Limitations Worth Knowing
Plaque quantification thresholds are not yet standardized across vendors, and outcome data linking specific quantified thresholds to management changes is still accumulating. Quantifying something precisely is not the same as knowing what to do with the number.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.