Cleerly's coronary artery disease (CAD) Staging System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
The system is a noninvasive imaging-based investigational software device that analyzes features of coronary atherosclerosis, stenosis, and ischemia. It aims to support physicians with risk assessment for patients at risk of major adverse cardiovascular events (MACE), including heart attacks, before they happen.
The Cleerly CAD Staging System was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot program, which helps companies make devices accessible to patients and physicians as quickly as possible. Additionally, the system will be used in the Transform randomized controlled trial that will enroll individuals who are asymptomatic for heart disease with diabetes, prediabetes, or metabolic syndrome.
