The U.S. Food and Drug Administration on July 29 granted de novo marketing authorization to Caristo Diagnostics for CaRi-Heart, the first AI-enabled software to directly measure and quantify coronary inflammation from routine coronary CT angiography (CCTA) scans.
Coronary Inflammation Becomes A Measurable, Reimbursable Biomarker
CaRi-Heart uses Caristo's Fat Attenuation Index Score (FAI-Score) to detect inflammation-driven changes in pericoronary adipose tissue, then delivers a personalised 10-year cardiovascular mortality risk estimate. The clearance (DEN250042) fills a critical diagnostic gap where roughly half of first-time heart attacks strike patients previously classified as low risk by traditional calcium scoring or standard CCTA. The American Medical Association has already assigned Category III CPT codes 0992T and 0993T for the technology, effective January 1, 2026, opening a defined reimbursement pathway.
A Second FDA Win On Top Of CaRi-Plaque
The de novo pathway lets Caristo create a new device classification for inflammation quantification from CCTA. It builds on the company's March 2025 510(k) clearance (K242240) for CaRi-Plaque, an AI-assisted plaque-analysis product that measures the presence, extent and severity of coronary plaques from the same CT scans. Together, the products let clinicians assess both plaque burden and hidden inflammation from a single CT — a "full-spectrum" view Caristo argues can catch high-risk patients years before symptoms appear.
Commercial Launch Starts This Quarter
Caristo Diagnostics — headquartered in Oxford, UK with U.S. operations in Stamford, Connecticut — plans to begin the U.S. commercial launch this quarter, targeting hospitals, health systems and longevity clinics, with broader rollout in Q4 2026. To scale, the company recently appointed David Vort as chief commercial officer and Chris Louk as chief financial officer. CaRi-Heart joins a fast-expanding fleet of FDA-cleared cardiac AI, from Cleerly's plaque analysis to Tempus AI's oncology diagnostics. The FDA has cleared more than 1,500 AI-enabled medical devices to date. Related coverage: J&J OTTAVA de novo.
Reporting based on coverage from Caristo Diagnostics, HIT Consultant, Diagnostic Imaging, Cardiovascular Business and 24x7 magazine.