FDA granted Caristo Diagnostics' De Novo request for CaRi-Heart on July 28. The grant, DEN250042, establishes a new Class II regulation at 21 CFR 870.2215 for a predictive indicator for long-term cardiovascular outcomes, product code SIU. FDA received the request on September 4, 2025; the review took 327 days. Caristo announced the decision on July 29.
CaRi-Heart reads routine coronary CT angiography and reports the FAI-Score, a measure of fat attenuation around the coronary arteries that tracks inflammation. It adds a personalized 10-year risk of cardiac mortality. Caristo says it is the first technology authorized in the U.S. to quantify coronary inflammation. The evidence base is ORFAN, an Oxford-led CT registry designed to reach 250,000 patients, with validation published in The Lancet.
Caristo spun out of the University of Oxford in 2018 and raised a £13M ($16.3M) Series A led by Oxford Science Enterprises in April 2023. Its CaRi-Plaque tool for quantitative plaque analysis already holds a 510(k). The AMA assigned Category III CPT codes 0992T and 0993T effective January 1, 2026. CEO Steve Deitsch said the U.S. launch starts this quarter and expands in the fourth.
Landing the CPT codes seven months before the authorization letter is the part other AI diagnostics will study. The code, not the regulation, decides whether an imaging center runs the analysis.