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Caristo Diagnostics Secures FDA Clearance for AI-Powered Coronary Plaque Detection
The FDA has cleared Caristo Diagnostics’ CaRi-Plaque, an AI-assisted software that detects and quantifies coronary plaque build-up and inflammation from routine coronary CT angiography (CCTA) scans. This breakthrough technology enables early coronary artery disease (CAD) detection, helping specialists take a proactive approach to heart attack prevention.
CaRi-Plaque analyzes de-identified CCTA data via a cloud-based platform, with results reviewed by trained operators and delivered in DICOM or PDF format. Identifying atherosclerosis early can guide interventions like coronary atherectomy, a minimally invasive procedure for plaque removal.
With CAD causing 370,000 deaths globally in 2022, AI-driven diagnostics are gaining traction. The coronary atherectomy device market is growing at 7.5% CAGR, projected to double in value by 2033. Competing platforms include Cleerly, which raised $106M in Series C funding, and HeartFlow, which launched its AI-powered CAD assessment tool in 2024.
13-03-2025