Caristo Diagnostics Gains FDA Clearance for AI Heart Attack Prevention Tool

Caristo Diagnostics has received FDA 510(k) clearance for its CaRi-Plaque technology, an AI-assisted image analysis application aimed at diagnosing coronary artery disease (CAD) announced in a press release. The technology is designed to provide precision in detecting coronary plaque, assisting cardiologists and radiologists in analyzing the type, volume, and severity of plaque.

CaRi-Plaque supports non-invasive analysis of coronary anatomy and pathology from routine coronary computed tomography angiography (CCTA) scans. This allows healthcare professionals to determine the presence, extent, and severity of coronary plaques and luminal stenosis. The technology builds on Caristo's core CaRi-Heart technology, which has been shown to predict heart attacks up to a decade before they occur.

The FDA clearance marks a significant step for Caristo as it looks to commercialize its technology in the U.S., targeting hospitals, health systems, and longevity clinics. The company aims to transform cardiac care by enabling earlier detection and personalized prevention of heart disease, potentially saving lives by identifying high-risk patients sooner.