Caristo Diagnostics Gains FDA Authorisation for AI-Based Heart Inflammation Assessment
Caristo Diagnostics has received U.S. FDA De Novo authorisation for CaRi-Heart®, an artificial intelligence (AI)-based technology designed to measure coronary inflammation from routine coronary CT angiography (CCTA) scans.
CaRi-Heart is the first FDA-authorised technology in the U.S. to quantify coronary inflammation, a key factor linked to coronary artery disease (CAD), plaque formation, and increased heart attack risk.
The solution enables clinicians to identify hidden cardiovascular risks and support more personalised treatment decisions.
The AI-powered platform analyses inflammation-related changes in the fat surrounding coronary arteries and generates a Fat Attenuation Index (FAI) Score™, a validated biomarker for coronary inflammation.
It also provides the CaRi-Heart Risk Score, which estimates an individual’s 10-year risk of cardiovascular mortality.
Caristo Diagnostics will begin the U.S. commercial launch of CaRi-Heart in 2026, following the assignment of Category III CPT® codes 0992T and 0993T by the American Medical Association, effective from January 2026.
Developed through research at the University of Oxford, CaRi-Heart has been validated through large clinical studies and supported by the Oxford Risk Factors And Non-invasive imaging study (ORFAN), a global coronary CT registry.
The technology complements Caristo’s FDA-cleared CaRi-Plaque® solution, expanding the company’s AI-driven cardiovascular disease management portfolio and supporting improved risk assessment and patient care.
