July 15, 2025 – Cleerly has announced that EviCore, a leading radiology benefit manager providing coverage guidelines to commercial health insurers, has released updated guidelines with positive coverage recommendations for AI-guided quantitative coronary CT angiography (AI-QCT), including Cleerly LABS Plaque Analysis. The updated coverage guidelines become effective Oct, 1, 2025.
EviCore's recommended patient selection criteria align with those established in the Medicare Local Coverage Determinations (LCDs) and include:
- Acute or stable chest pain with no known coronary artery disease
- Completed and interpreted coronary computed tomography angiography (CCTA) with intermediate risk or CAD-RADS 1, 2, or 3, or 1-70% stenosis
- Cardiac evaluation is negative or inconclusive for acute coronary syndrome
This follows Cleerly's efforts to petition Medicare coverage for AI-QCT products. The positive coverage from Medicare, and now EviCore, represents a significant step forward in making advanced cardiac imaging technology accessible to more patients. Commercial health insurers will make individual decisions on guideline adoption and implementation timing based on EviCore's updated recommendations.
Cleerly LABS’ Plaque Analysis is the only AI-based plaque tool that has published data comparing the tool to multiple industry leading invasive imaging modalities, including intravascular ultrasound (IVUS) with a .96 AUC1,2, near-infrared spectroscopy (NIRS) with a .97 AUC1, and optical coherence tomography (OCT) with data to be published this year. Cleerly's Plaque Analysis was validated against Level III readers, and an extensive list of post-market published clinical data can be found on Cleerlyhealth.com.
"By including Cleerly LABS Plaque Analysis in their coverage guidelines, EviCore is helping to ensure that patients and physicians have access to the most advanced, clinically tested AI-powered tools for coronary plaque assessment. This will enable more personalized, precise care decisions for patients with coronary artery disease," said James K. Min, MD, founder and CEO of Cleerly.
The inclusion of Cleerly LABS Plaque Analysis in EviCore's guidelines underscores the growing recognition of AI-powered cardiac imaging as a critical component of modern cardiovascular care. By providing detailed, quantitative analysis of coronary plaque composition and burden, Cleerly's technology enables clinicians to make more informed treatment decisions and deliver personalized care to patients with suspected or known coronary artery disease.
References
- Omori, Hiroyuki, et al. Determination of lipid-rich plaques by artificial intelligence-enabled quantitative computed tomography using near-infrared spectroscopy as reference. Atherosclerosis, vol. 386, 2023
- Data on file
July 25, 2025 
