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FDA Grants Breakthrough Device Designation to Cleerly® for Heart Disease Risk Staging System

Wednesday, March 06, 2024

Cleerly, an innovative company dedicated to advancing heart disease diagnosis, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System. This system utilizes noninvasive imaging-based software to analyze coronary atherosclerosis, stenosis, and ischemia, aiming to provide physicians with a more precise risk assessment for patients at risk of major cardiovascular events like heart attacks.

The FDA's Breakthrough Device Designation recognizes technologies with the potential to improve the diagnosis or treatment of life-threatening diseases. Cleerly's CAD Staging System has also been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot, which aims to expedite patient access to breakthrough devices.

This FDA designation underscores the urgent need for better heart disease risk assessment methods. Cleerly's CAD Staging System will undergo further validation in the TRANSFORM randomized controlled trial, focusing on asymptomatic individuals with diabetes, pre-diabetes, or metabolic syndrome.

Presently, heart disease risk assessment relies heavily on risk factors rather than direct CAD diagnosis, which poses limitations in predicting individual CAD severity and risk. Cleerly is committed to making its technology available to healthcare providers and patients, aiming to revolutionize heart disease prevention and treatment.




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