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.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
