CaRi-Plaque AI Image Analysis Wins FDA Nod to Spot Coronary Artery Disease

Caristo Diagnostics has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for CaRi-Plaque, an artificial intelligence (AI)-assisted image analysis application to help diagnose coronary artery disease (CAD).

CaRi-Plaque supports non-invasive coronary artery analysis and pathology from routine coronary CT angiography (CCTA) scans to ascertain the presence, extent, and severity of coronary plaques and luminal stenosis. It builds on the company’s core CaRi-Heart tech, which a Lancet study proved can reveal hidden, high-risk CAD progression markers and predict heart attacks up to a decade before they occur.

CT scan data is sent to the cloud with one mouse click, according to Caristo. The company first de-identifies the data before its CaRi-Plaque software processes the images for preliminary plaque analysis. Trained operators then review the results, generate a report, and send it to the original clinician in either DICOM-conformant or PFD format.

A 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 available on a research basis only.

“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.”