Heartflow Sues Cleerly Over AI Cardiology Technology

Heartflow Inc. has filed a patent infringement lawsuit against Cleerly Inc., claiming it beat its competitor to the punch in developing and marketing an artificial intelligence (AI)-powered, non-invasive cardiac diagnostic platform.

Filed April 13 in U.S. District Court for the Eastern District of Texas, the 180-page complaint seeks permanent injunctive relief and damages arising from Cleerly’s unauthorized and continued use of Heartflow’s patented technology. Heartflow asserts that Cleerly’s Ischemia, Plaque Analysis, and Compare products infringe six of Heartflow’s patents with priority dates from 2012 to 2018, protecting Heartflow innovations developed years before the introduction of any Cleerly product.

“Heartflow pioneered a significant medical technology that has touched over 600,000 patients’ lives. Our team has worked tirelessly since 2010 to develop the Heartflow Platform, a first-of-its-kind AI solution that has been used to detect and manage coronary artery disease,” Heartflow CEO John Farquhar said. “We take seriously our responsibility to protect the intellectual property that supports this field and the clinicians and patients it serves.”

Cleerly Founder/CEO James K. Min, M.D., however, issued a statement affirming the originality of his company’s technology: “Cleerly is aware of the lawsuit filed by Heartflow. We are confident in our extensive and well-established intellectual property portfolio and the originality of our technology,” he said. “Cleerly has published landmark clinical science that has redefined how cardiovascular disease is understood and treated, which has formed the basis of our novel technologies that provide physicians with actionable insights into their patients’ heart health. Cleerly was founded on a mission to create a world without heart attacks, and we have never been more focused in our mission and committed to the patients and physicians who count on us.”

Nevertheless, Heartflow insists in its lawsuit that Cleerly used patent-protected information to build its technology. “”Cleerly built its competing platform by leveraging technology and confidential information derived from Heartflow’s innovation and protected by Heartflow’s patents,” the lawsuit states.

Heartflow maintains an intellectual property portfolio comprising more than 600 granted patent assets worldwide.

Heartflow’s technology is attempting to redefine precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 600,000 patients worldwide.¹ Key benefits include:

• Proprietary data pipeline: Built from more than 160 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.
• Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in more than 200 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.
• Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.
• Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001.

Cleerly claims it uses proprietary and U.S. Food and Drug Administration-cleared machine learning algorithms to non-invasively measure atherosclerosis (plaque), stenosis, and likelihood of ischemia using coronary computed tomography angiography (CCTA) studies. Its machine-learning AI generates a 3D model of the patient’s coronary arteries, identifies their lumen and vessel walls, locates and measures stenoses, while quantifying and categorizing plaque. 

On its website, Cleerly says its analyses are grounded in science, based on over 10 million images from more than 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials.

Heartflow is striving to transform coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow—all without invasive procedures.