Cleerly® Gets FDA Breakthrough Designation for Heart Disease Risk Staging System

Cleerly, a company dedicated to reshaping the landscape of heart disease diagnosis, has achieved a significant milestone by securing the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its groundbreaking Coronary Artery Disease (CAD) Staging System. This innovative system, driven by noninvasive imaging-based investigational software, meticulously analyses critical aspects of coronary atherosclerosis, stenosis, and ischemia. Its primary objective is to empower physicians with a more precise and individualised risk assessment tool for patients susceptible to major adverse cardiovascular events (MACE), including heart attacks, before they manifest.

The FDA's endorsement through the Breakthrough Device Designation reflects the potential of Cleerly's technology to revolutionise the diagnosis and treatment of life-threatening or debilitating diseases. By supporting novel advancements like Cleerly's CAD Staging System, the FDA ensures their prompt availability, especially in cases where no approved alternatives exist or where substantial improvements over existing solutions are anticipated.

Furthermore, Cleerly's CAD Staging System's inclusion in the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot underscores its significance. Only devices granted Breakthrough Device Designation are admitted into this program, which aims to expedite their accessibility to patients and healthcare providers.

The journey doesn't end here for Cleerly's CAD Staging System; it will undergo rigorous validation in the transformative TRANSFORM randomised controlled trial. This landmark trial will enrol asymptomatic individuals with conditions such as diabetes, pre-diabetes, or metabolic syndrome. Presently, assessments for future MACE in asymptomatic patients rely primarily on risk factors, which, although useful across populations, often lack the specificity required for individual risk prediction. Cleerly's system promises to bridge this gap by offering more accurate diagnosis and staging of CAD, addressing the underlying cause of the majority of heart attacks.

Driven by a commitment to expedite the deployment of its innovative technology, Cleerly is steadfast in its mission to revolutionise heart disease prevention and treatment. Beyond mere innovation, Cleerly's mission is rooted in the profound goal of saving lives through transformative advancements in cardiovascular care.

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