March 11, 2025 — Caristo Diagnostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its CaRi-Plaque technology, an AI-assisted image analysis application to aid the diagnosis of coronary artery disease (CAD).
The CaRi-Plaque technology supports non-invasive analysis of coronary anatomy and pathology from routine coronary computed tomography angiography (CCTA) scans to determine the presence, extent and severity of coronary plaques and luminal stenosis (narrowing of arteries). CaRi-Plaque builds on Caristo’s core CaRi-Heart technology, which a Lancet 2024 study proved can reveal hidden, high-risk markers of CAD progression — predicting heart attacks up to a decade before they strike.
“For decades, heart disease has been treated reactively, waiting for symptoms to appear before taking action. But with AI, we can change that. 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, CEO, Caristo Diagnostics. “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. This is a major step toward redefining the standard of cardiac care.”
“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, MSCCT, FASNC, FACC, cardiologist and Director of Advance Imaging at Midwest Heart & Vascular Specialists in Kansas City, the HCA Midwest Division. “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. We look forward to expanding our research and collaboration with Caristo to clinical adoption in the future.”
Ordering a CaRi-Plaque analysis from Caristo is seamless for healthcare professionals. CT scan data can be sent to the cloud with a simple mouse click. Caristo first de-identifies the data before processing the images through its CaRi-Plaque software for preliminary plaque analysis. Trained Caristo Operators then review the results, generate the CaRi-Plaque Report, and deliver it to the originating healthcare professional in either DICOM-conformant or PDF format.
"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 Dr. John Simon, founder and CEO of SimonMed Imaging. "We look forward to our collaboration with Caristo to push diagnoses forward to potentially even earlier detection with coronary inflammation detection from Caristo’s unique FAI-Score technology."
CaRi-Plaque’s precision and accuracy have been comprehensively validated against expert clinical consensus. The validation study determined the degree of consistency between plaque characteristics reported by CaRi-Plaque and qualified independent medical expert readers using a multi-center, international patient population. CaRi-Plaque is covered by the AMA’s new Category I CPT code, 75XX6, which takes effect in January 2026. Until then, CaRi-Plaque users are covered by the Category III CPT codes (0623T - 0626T).
In the U.S., CaRi-Heart is currently available for research only.
For more information, visit caristo.com.
January 15, 2026 
