UK firm Caristo Diagnostics has received US FDA 510(k) clearance for its CaRi-Plaque technology, an AI-assisted image analysis application to aid the diagnosis of coronary artery disease.

Coronary inflammation causes plaque build-up in the arteries, which is a silent killer, driving millions of heart attacks and strokes in the USA. 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 destabilise plaques, making them rupture without warning, which then leads to blockage of the artery. To prevent heart disease, cardiologists, radiologists and preventive care specialists must detect and then tackle both the plaque build-up 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 Lancet 2024 study (www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00596-8/fulltext) proved can reveal hidden, high-risk markers of heart disease 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,” said Frank Cheng, CEO of Caristo Diagnostics. “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, personalised heart attack prevention. By identifying both plaque build-up 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 towards redefining the standard of cardiac care.”

Kansas cardiologist Stephen Bloom added: “We stand on the brink of revolution in the prevention and treatment of coronary disease, thanks to Caristo’s ability to analyse plaque and inflammation on coronary CT scans. 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 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 programme and the multiple treatment pathways now available,” said John Simon, CEO of SimonMed Imaging (www.simonmed.com), the largest independent radiology practice in the USA. “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 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-centre, international patient population.

A spinout from the University of Oxford, Caristo Diagnostics (caristo.com) is a specialist in AI-powered heart disease detection. Its technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear.