Caristo wins FDA authorization for cardiovascular risk predictor

Caristo Diagnostics, a University of Oxford spinout, received FDA de novo authorization for CaRi-Heart, an AI tool that uses coronary computed tomography angiography to quantify coronary inflammation and estimate 10-year cardiovascular mortality risk, helping identify high-risk patients without obstructive coronary artery disease.

This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 4 Aug 2026 and 5 Aug 2026.