March 6, 2024 — Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System. The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia. Its purpose is to support physicians with a more accurate and personalized risk assessment for patients at risk of major adverse cardiovascular events (MACE), including heart attacks, before they happen.
The FDA’s Breakthrough Device Designation is granted for technologies that have the possibility to encourage more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The FDA supports these novel technologies to ensure timely availability when no approved alternatives exist and/or because these technologies hold potential for considerable improvement over existing approved alternatives for patients.
The Cleerly CAD Staging System was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot. Only devices that have gained Breakthrough Device Designation are accepted into the TAP Pilot, with the purpose to help companies make these devices accessible to patients and physicians as quickly as possible.
“As Cleerly continues to develop cardiovascular innovations to support patients and healthcare professionals, we are honored to have received Breakthrough Device Designation and join the TAP Pilot,” said James K. Min, MD, Founder and CEO of Cleerly. “This designation from the FDA highlights the critical need for better heart disease risk assessment methods. Our approach to heart disease, inspired by the most successful preventive care paradigms in medicine – including mammograms, colonoscopies, and lung CTs – enables personalized diagnosis and risk assessment and exemplifies our commitment to enhancing CAD evaluation, aiming to prevent heart attacks before they occur.”
The Cleerly CAD Staging System will be further validated in the landmark TRANSFORM randomized controlled trial that will enroll individuals who are asymptomatic for heart disease with diabetes, pre-diabetes or metabolic syndrome. Current assessment for future MACE in asymptomatic patients is still based on risk factors rather than the diagnosis and staging of actual CAD, the cause for the vast majority of heart attacks. While risk factors show reasonable prognostic value across a large population, they are indirect markers of CAD, and their relationship with CAD severity and CAD risk on an individual level is unpredictable and unreliable.
“As our Cleerly CAD Staging System becomes available to physicians and patients, it will provide the rationale for preventive tailored treatment of CAD with risk-based therapy goals,” said Udo Hoffmann, MD, MPH, Chief Scientific Officer of Cleerly. “We are thrilled that we’re able to work closely with the FDA and our TRANSFORM partners to demonstrate the effectiveness of the CAD Staging System in a scientifically rigorous way and eventually offer it to all patients who may benefit.”
Cleerly is committed to accelerating the availability of its technology to healthcare providers and patients alike. Cleerly’s mission extends beyond innovation; it is a commitment to saving lives by revolutionizing the prevention and treatment of heart disease.
For more information: www.cleerlyhealth.com
March 27, 2026 
