Caristo Secures FDA Clearance, Ushering in a New Era of AI-Powered Heart Attack Prevention
- FDA 510(k) clearance of Caristo's CaRi-Plaque™ technology advances AI innovator's U.S. commercialization, as it looks to roll out to hospitals, health systems and longevity clinics
- The CaRi-Plaque technology delivers AI-driven precision in coronary plaque detection, helping cardiologists and radiologists analyze type, volume, and severity of plaque
- Clinics using CaRi-Plaque can seamlessly adopt Caristo's CaRi-Heart® when cleared by FDA, enabling the analysis of both plaque and coronary inflammation—providing an unprecedented, full-spectrum view of heart disease before symptoms arise
STAMFORD, Conn., March 11, 2025 /PRNewswire/ -- Caristo Diagnostics, on a mission to transform the diagnosis and treatment of cardiovascular disease, today announced it 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).
Coronary inflammation causes plaque buildup in the arteries, which is a silent killer, driving millions of heart attacks and strokes in the U.S. Over time, fatty plaque deposits damage the coronary artery wall, often without symptoms — until disaster strikes. Statins and blood pressure medications slow this progression, but many heart attacks happen in arteries that were previously not narrowed. That's because inflammation can destabilize plaques, making them rupture without warning, which then leads to blockage of the artery. To truly prevent heart disease, cardiologists, radiologists, and preventive care specialists must detect and then tackle both the plaque buildup and the hidden inflammation that makes it deadly.
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 breakthrough core CaRi-Heart® technology, which a landmark 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, the largest independent radiology practice in the United States. "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.
About Caristo Diagnostics
Caristo Diagnostics is a global leader in AI-powered heart disease detection. A spinout from the University of Oxford, Caristo's award-winning technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear. Backed by leading hospitals and scientists, Caristo is on a mission to save lives through early detection and personalized prevention. For more information, visit caristo.com. Find Caristo online on LinkedIn, YouTube, and X.
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