FDA authorizes first AI tech for visualizing coronary inflammation in CT scans
The U.S. Food and Drug Administration (FDA) has granted de novo market clearance for the first and only biomarker technology to directly see and quantify coronary inflammation from routine coronary CT angiography (CCTA).
The CaRi-Heart technology from Caristo Diagnostics has been heralded by numerous cardiac CT experts as a potential paradigm shift in cardiology. It is the first technology that can visualize and clearly quantify coronary inflammation using fat attenuation index (FAI) scores. This helps care teams estimate the residual risk of heart attacks in patients who otherwise appear to be managed well on optimal medical therapy.
“We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” Ron Blankstein, MD, director of cardiac CT at Brigham and Women's and a former Society of Cardiovascular Computed Tomography (SCCT) president, said in a statement. “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 U.S.”
“With CaRi-Heart’s authorization, we begin a new era of cardiovascular care in the U.S.,” added Steve Deitsch, CEO of Caristo Diagnostics. “This milestone is the result of more than a decade of groundbreaking work by our co-founders at the University of Oxford, clinical research partners, and the entire Caristo team."
Caristo said it will begin commercial launch of CaRi-Heart in the U.S. in the coming weeks.
CaRi-Heart uses artificial intelligence (AI) to show the attenuation of the fat surrounding coronary vessels caused by inflammation in the vessel wall. Combined with AI plaque analysis, the technology can pinpoint high-risk, vulnerable plaques. It also can be used in serial exams to show decreases in inflammation from medications and indicate which patients may be able to lower certain risk with the addition of the anti-inflammatory drug colchicine.
American Medical Association (AMA) Category III Current Procedural Terminology (CPT) tracking codes 0992T and 0993T are applicable for CaRi-Heart, and have been effective since Jan. 1, 2026. These codes will track usage of the technology to determine later if permanent Category 1 codes for payments should be created.
FAI highlighted as a major breakthrough technology at SCCT 2026
At SCCT2026, the recent SCCT annual meeting, FAI technology was mentioned in a vast number of sessions presented at the meeting. The specialists who spoke to Cardiovascular Business during the conference agreed this technology could make a big impact going forward.
CaRi-Heart is already cleared in some countries, including Australia. Early adopter Imre Hunyor, DPhil (Oxon), MBBS (Hons), cardiologist at Central Sydney Cardiology, shared his experience with it during an interview with Cardiovascular Business.
"Nearly half of those patients with normal coronary CT angiograms have very high coronary inflammation," Hunyor said. "That translates to a substantially increased risk of cardiac death within the next 10 years. You don't need a blockage or a serious plaque volume to have a heart attack. You can have a very small volume of plaque, but if that plaque becomes inflamed it can rupture."
He said FAI scores enable more accurate, personalized risk assessments and treatments than what is typically seen when patients seek care.
Ability to image inflammation may change how clinicians care for patients
Coronary inflammation is needed for atherosclerosis to become high-risk plaques that rupture and cause heart attacks. While lipid-lowering therapies such as statins help to reduce inflammation, there has been a missing link in preventive care that can clearly identify residual heart attack risk from hidden coronary inflammation. There have been calls for wider use of high-sensitivity C-reactive protein (hsCRP) blood testing to reveal this risk, but many experts have argued it is a systemic test, which shows evidence of inflammation from anywhere in the body, and is not cardiac specific. FAI imaging, on the other hand, is specifically focused on the coronaries.
"I think this is going to be yet another evolution here where we're going to take these contrast CTs and say, not only do you have a certain amount of plaque and a certain amount of physiological stenosis, but you also have coronary inflammation, and we can treat that differently," explained Matthew Budoff, MD, Endowed Chair of Preventive Cardiology at Harbor-UCLA Medical Center and a former SCCT president, told Cardiovascular Business. "We're going to have a number of approved anti-inflammatories down the road for coronary inflammation. We have colchicine right now, which has an indication to prevent heart attacks and strokes in these patients, but we're going to have other drugs that are very far along in development to look at blocking Interleukin-6, other angles to treat this coronary inflammation."
Budoff is involved as a principal investigator in one of these next-generation drug trials. He said there are other drug trials in progress that are using changes in the FAI score as the primary endpoint.
"The Oxford group has done a lot of research in this area of vascular biology and it is fascinating, and it is opening our eyes to the pathways behind coronary inflammation," explained Ed Nicol, MD, head of cardiovascular CT at Royal Brompton Hospital in London and another former SCCT president, told Cardiovascular Business. "This is the evolution of medicine. We are very fortunate in imaging to now have technologies to use AI, in this case radiomics, to give us insights."
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]