FDA Authorizes AI Tool CaRi-Heart for Cardiovascular Risk Assessment

The FDA has granted De Novo authorization to CaRi-Heart, an AI-powered medical device designed to analyze CCTA images for coronary inflammation. This tool generates a proprietary fat attenuation index score, which translates into a 10-year cardiovascular mortality risk score, addressing a critical gap in identifying heart attack risk in traditionally low-risk patients. This represents an advancement in diagnostic capabilities for heart disease.