Sept. 30, 2025 — Cleerly has announced that coverage policies from UnitedHealthcare and Cigna for Cleerly LABS advanced plaque analysis will go into effect Oct. 1, 2025. These landmark decisions mark a new era in cardiac care, bringing AI-guided quantitative coronary CT angiography (AI-QCT)/Coronary Plaque Analysis (AI-CPA) within reach of millions of Americans.
Starting Oct. 1, 2025, patients will have access through streamlined coverage criteria that mirrors Medicare's established local coverage determinations and EviCore’s recently updated guidelines.
AI-QCT/AI-CPA using CCTA is considered reasonable and medically necessary as a diagnostic study when:
- The patient has acute or stable chest pain with no known CAD and is eligible for CCTA, and
- CCTA classifies patient as:
- Intermediate risk OR
- CAD-RADS 1, CAD-RADS 2 or CAD-RADS 3, category on CCTA, AND
- Cardiac evaluation is negative or inconclusive for acute coronary syndrome (ACS)
Cleerly LABS’ advanced plaque analysis is an AI-based plaque tool with peer-reviewed data comparing it to multiple industry-leading invasive imaging modalities, including intravascular ultrasound (IVUS) with a .96 AUC1,2 and near-infrared spectroscopy (NIRS) with a .97 AUC1. Cleerly's advanced plaque analysis was also validated against Level III readers, and an extensive list of post-market published clinical data can be found on cleerlyhealth.com.
"We're witnessing a paradigm shift in how we approach heart disease," said James K. Min, MD, founder and CEO of Cleerly. "With United Healthcare and Cigna recognizing the power of AI-driven advanced plaque analysis in their coverage policies, they are not only embracing innovation, they are helping to redefine standards of care consistent with the latest clinical evidence to improve patient outcomes. Starting October 1st, doctors can base treatment decisions on precise, quantitative plaque data that was previously available only through invasive procedures."
With this coverage announcement, more patients will benefit from Cleerly's ability to quantify and characterize coronary plaque noninvasively. The platform's detailed analysis of plaque composition gives cardiologists the specific data they need to personalize and optimize treatment, while helping to avoid the unnecessary risks and costs associated with invasive diagnostic procedures.
Visit www.cleerlyhealth.com to learn more.
- 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
November 14, 2025 
