The Food and Drug Administration (FDA) has granted Breakthrough Device designation to Clerly’s coronary artery disease (CAD) staging system.

A CAD staging system that provides a four-step approach that incorporates assessment of total plaque volume (TPV) and percent atheroma volume (PAV) from quantitative computed tomography (CT) to detect stenosis, ischemia, and coronary atherosclerosis. Cleary said it provides insight into practical aspects of sclerosis.

Cleary’s Coronary Artery Disease (CAD) Staging System provides a four-step approach to assessing an individual’s risk of heart disease and has received breakthrough device designation from the Food and Drug Administration (FDA). Ta. (Image provided by: Journal of Cardiovascular Computed Tomography. )

Clerly highlighted the potential of the system to provide an individual risk assessment for heart disease, and is currently investigating the use of the CAD staging system in randomized controlled trials for patients with diabetes, prediabetes, or metabolic syndrome who have no symptoms of heart disease. (TRANSFORM).

“When our Clerly CAD Staging System becomes available to physicians and patients, it will provide a rationale for preventive, individualized treatment of CAD with risk-based treatment goals,” said Clerly’s Chief Scientific Officer. said lead author Udo Hoffmann, MD, MPH.