FDA Clears AI-Assisted CaRi-Plaque Image Analysis for CAD

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the CaRi-Plaque artificial intelligence (AI)-assisted image analysis application to support the diagnosis of coronary artery disease (CAD).1

Announced by Caristo Diagnostics, on March 11, 2025, the technology allows for non-invasive analysis of coronary anatomy and pathology from routine coronary computed tomography angiography (CCTA) scans to determine the presence and severity of coronary plaques and luminal stenosis.

“We stand on the brink of revolution in the prevention and treatment of coronary disease, thanks to Caristo’s ability to analyze plaque and inflammation on coronary CT scans,” said Stephen A. Bloom, MD, director of advance imaging at Midwest Heart & Vascular Specialists.1 “This advancement enables us to diagnose early stages of coronary disease, even before a coronary CT calcium score becomes positive, allowing for earlier intervention and treatment.”

Characterized by the formation of atherosclerotic plaque, CAD can damage the coronary artery wall and leave individuals susceptible to myocardial infarction and stroke. Treatment options include lifestyle modification and pharmacologic options, such as statins and β-blockers, to reduce further plaque buildup. However, inflammation can destabilize plaques, rupture without warning, and block an artery.2

The CaRi-Plaque technology follows the company’s CaRi-Heart technology, which accurately predicts long-term fatal and non-fatal cardiac events by quantifying coronary artery inflammation. A previous report analyzed inflammatory and cardiovascular risk among 40,000 patients enrolled in the ORFAN registry without obstructive CAD.

Among half (50%) of the population with no to minimal coronary plaque at the initial CCTA scan, those with abnormal perivascular fat attenuation index (FAI) scores experienced a 9.5-fold increased risk for cardiac mortality and 5.5-fold higher risk for major adverse cardiovascular events (MACE). The CaRi-Heart risk score outperformed other scores in routine clinical use for the prediction of cardiac mortality and led to a change in clinical management decisions in 45% of patients.3

“We now have the opportunity to prevent hundreds of thousands of deaths yearly from heart attack and stroke by using the knowledge gained from cardiac CT angiography combined with advanced AI technologies like the Caristo plaque program and the multiple treatment pathways now available,” said John Simon, MD, founder and chief executive officer of SimonMed Imaging.1

Healthcare professionals can upload CT scan data to the cloud, from which Caristo will de-identify the data and process the image through the CaRi-Plaque software for preliminary plaque analysis. A trained Caristo operator will review the data, generate a CaRi-Plaque report, and deliver it to the healthcare professional.1

“With FDA clearance for CaRi-Plaque, hospitals, and clinics can now move beyond traditional diagnostics and into truly proactive, personalized heart attack prevention,” said Frank Cheng, chief executive officer of Caristo Diagnostics.1 “By identifying both plaque buildup and hidden inflammation, we’re giving physicians the tools to catch high-risk patients earlier, tailor treatments more precisely, and ultimately, save more lives.”

References

1. Caristo secures FDA clearance, ushering in a new era of AI-Powered Heart Attack Prevention. Caristo.com. March 11, 2025. Accessed March 11, 2025. https://www.caristo.com/caristo-secures-fda-clearance-ushering-in-a-new-era-of-ai-powered-heart-attack-prevention/.

2. Shahjehan RD, Sharma S, Bhutta BS. Coronary Artery Disease. [Updated 2024 Oct 9]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK564304/.

3. The Lancet publishes results from world’s largest coronary CT registry showing new AI technology can predict cardiac events due to coronary inflammation at least 10 years in advance. Caristo.com. May 30, 2024. Accessed March 11, 2025. https://www.caristo.com/the-lancet-publishes-results-from-worlds-largest-coronary-ct-registry-showing-new-ai-technology-can-predict-cardiac-events-due-to-coronary-inflammation-at-least-10-years-in-advance/.