Caristo Diagnostics’ CaRi-Heart Coronary Inflammation Technology Receives FDA De Novo Authorization

July 30, 2026—Caristo Diagnostics announced that the FDA has granted de novo authorization for the company’s CaRi-Heart to quantify coronary inflammation from routine coronary CT angiography (CCTA).

Caristo stated it will begin the commercial launch of CaRi-Heart in the United States in Q3 and expand during Q4 2026.

The American Medical Association has assigned category III Current Procedural Terminology (CPT) codes—CPT 0992T and CPT 0993T—that are applicable for CaRi-Heart, effective since January 1, 2026.

CaRi-Heart is also available in Europe, Switzerland, the United Kingdom, and Australia, advised Caristo.

As stated in the press release, CaRi-Heart, which is Caristo’s flagship technology, uses advanced artificial intelligence (AI) to detect inflammation-related changes in the fat surrounding the coronary arteries and quantify them as a fat attenuation index score (FAI-Score). FAI-Score is Caristo’s validated proprietary biomarker of coronary inflammation.

The analysis also generates the CaRi-Heart Risk Score, which is a personalized estimate of a patient's risk of cardiovascular mortality over 10 years. The company noted CaRi-Heart has been validated in large independent populations and published in peer-reviewed journals, including The Lancet (Chan et al; 2024;403:2606-2618).

Additonally, Caristo stated that CaRi-Heart is supported by ORFAN—the Oxford Risk Factors and Noninvasive Imaging Study—a coronary CT registry that aims to include long-term outcomes data from up to 250,000 patients worldwide.

“We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” commented Ron Blankstein, MD, in the company’s press release. “And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard CCTA, or calcium scoring alone. It is exciting to see Caristo’s long-awaited, pioneering solution available in the United States.” Dr. Blankstein is from Harvard Medical School and Brigham and Women’s Hospital in Boston, Massachusetts.