Rcadia Medical Imaging has received CE mark for the COR Analyzer System, a software that helps identify patients with coronary artery disease (CAD) by a fully automatic analysis of coronary CT angiography (cCTA) studies.
The CE mark allows Rcadia Medical to market the system in the European Union and other countries that accept the CE mark registration. The COR Analyzer is marketed in the US under 510(k) clearance.
The COR Analyzer System processes patient images from cCTA studies generated by all four manufacturers of 64 slice (and above) and produces results in real time that determine whether there are lesions (more than 50% stenosis) in major coronary arteries. The system provides visualization tools, allowing the clinician to validate the findings and see the precise location of detected lesions.
In the clinical studies, the COR Analyzer System has demonstrated high negative predictive value. In a recent analysis of cCTA images from low to moderate risk emergency department patients with chest pain, presented at the Radiological Society of North America annual meeting, the COR Analyzer yielded a negative predictive value (NPV) of 98% compared with expert readers.
Shai Levanon, president and CEO of Rcadia, said: “The CE mark is an important milestone in Rcadia’s program to advance the practical application of coronary CT angiography. The COR Analyzer is a powerful, time and cost-effective tool to support clinical decision making.
“The system’s real time coronary artery analysis has demonstrated great potential in emergency department triage to help rule out coronary artery disease in chest pain patients, reducing unnecessary hospitalizations and improving patient care. The COR Analyzer is also designed to optimize workflow in cardiology and radiology departments.”