The US Food and Drug Administration (FDA) has granted clearance to Caristo Diagnostics for CaRi-Plaque, an AI-assisted software application that diagnoses coronary artery disease (CAD).
The software quantifies coronary inflammation and arterial plaque build-up based on routine coronary computed tomography angiography (CCTA) scans.
CAD was responsible for around 370,000 deaths globally in 2022, which occurs when plaque has built up in the arteries to a point where it causes ruptures, which can result in the formation of blood clots that block blood flow to the heart.
According to Caristo, the software aids specialists to detect and tackle both plaque build-up and the hidden inflammation that makes it deadly.
Caristo CEO Frank Cheng commented: “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, personalised heart attack prevention.
For preliminary plaque analysis from CCTA scans, healthcare professionals can send CT data for analysis. First sent to a cloud-based platform, Caristo then de-identifies the data before processing it through CaRi-Plaque.
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Following the analysis, trained Caristo operators review the results and generate a report in 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,” commented Dr John Simon, founder and CEO of independent radiology practice SimonMed.
Once plaque build-up, also known as atherosclerosis, is determined, one approach towards treating CAD, the symptoms of which may include chest pain (angina) and shortness of breath, is the performance of a coronary atherectomy, a minimally invasive procedure used to remove plaque build-up from the coronary arteries.
According to GlobalData’s Market Size & Growth database, the global coronary atherectomy device market is growing at a CAGR of 7.5% and is forecast to more than double its value from $242m in 2023 to $497m by 2033.
Other companies working on platforms for diagnosing CAD include Cleerly, which recently concluded a $106m Series C funding round to advance its AI-driven CAD platform; and HeartFlow, which launched a platform that applies AI to CCTA to assess the presence and volume of arterial plaque in July 2024.
