Congratulations to Cleerly on their Breakthrough Device Designation for their Coronary Artery Disease (CAD) Staging System. Their CAD Staging System was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot, a program exclusive to devices granted Breakthrough Device Designation, aimed to help companies make these devices available to patients and physicians as quickly as possible. Cleerly aims to address the critical need for personalized diagnosis and risk assessment of heart disease. If successful, their CAD evaluation system allows physicians and patients to prevent heart attacks before they occur. #hearthealth #coronaryarterydisease #healthinnovations
We’re pleased to announce we’ve been granted Breakthrough Device Designation by the FDA for our Coronary Artery Disease (CAD) Staging System. It’s a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia. Our CAD Staging System was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot and will be further validated in the landmark TRANSFORM trial we’re working on with our cross-industry partners. Read our full announcement for details on what this means for the future of more accurate and personalized heart disease risk assessment. #YesCCT #HeartHealth https://lnkd.in/gp8Am2Qn
