Aetna Approves Coverage for Cleerly's AI Cardiovascular Imaging Analysis

Major Insurer Joins UnitedHealthcare, Cigna, and Humana in Covering Cleerly's AI-QCT Technology as Industry Momentum Builds with 86+ Million Lives Now Covered

DENVER--(BUSINESS WIRE)--Cleerly, a leader in AI-based cardiovascular imaging, today announced that Aetna will begin covering Cleerly^® LABS plaque analysis effective immediately. Aetna, which covers more than 20+ million lives, joins UnitedHealthcare, Cigna, Humana, BCBS Kansas City, Excellus BCBS, and EviCore in providing coverage for this advanced technology.

Cleerly LABS is an interactive analysis software that leverages AI/ML-based advanced plaque analysis to identify, characterize, and quantify coronary artery plaque and stenosis, supporting visualization and measurement of coronary arteries in patients with known or suspected coronary artery disease (CAD).

This milestone reflects the rapid industry adoption of Artificial Intelligence Enabled CT-Based Quantitative Coronary Tomography (AI-QCT)/Coronary Plaque Analysis (AI-CPA) in cardiovascular care. Following Medicare's 2024 coverage decision and the technology's approval for a CPT^® I code effective January 1, 2026, major commercial payors representing over 86+ million Americans now support AI-QCT/AI-CPA coverage.

Coverage Criteria

CCTA plaque quantification or coronary plaque analysis using data from CCTA when all of the following criteria are met:

1. The plaque quantification and/or analysis platform has been FDA-cleared; and
2. The member has acute or stable chest pain with no known coronary artery disease (CAD); and
3. The member has had a current CCTA and the results indicate any of the following risk categories; Note: CCTA plaque quantification or coronary plaque analysis is not indicated for CAD-RAD 4, 5, and/or N; see Appendix for category definitions:
   1. Intermediate risk
   2. CAD-RADS 1
   3. CAD-RADS 2
   4. CAD-RADS 3; and
4. Physical examination and other cardiac testing (e.g., electrocardiogram, laboratory testing) are negative or inconclusive for acute coronary syndrome

"We're seeing unprecedented payor acceptance of AI-powered cardiovascular imaging," said James K. Min, MD, founder and CEO of Cleerly. "Major insurers, covering over 86 million lives, now recognize that AI-QCT delivers better patient outcomes while reducing costs. This is a fundamental shift in how we approach cardiac care."

This growing payor support reflects increasing clinical evidence that AI-QCT/AI-CPA supports the assessment of coronary artery disease by enhancing diagnostic evaluation and enabling efficient use of healthcare resources. These advances are critical for addressing cardiovascular disease, the leading cause of death in the United States.

Visit www.cleerlyhealth.com to learn more.

About Cleerly

Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive CT imaging. Cleerly’s approach is grounded in science, based on millions of images from over 40,000 patients. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: cleerlyhealth.com.