Rcadia Medical Imaging today announced that it has received a CE Mark for the COR Analyzer® System, its proprietary software that helps identify patients with significant CAD (Coronary Artery Disease) by a fully automatic analysis of coronary CT angiography (cCTA) studies. The CE Mark allows the company to market the system in the European Union and other countries that accept the CE Mark registration. The COR Analyzer is marketed in the U.S. under 510(k) clearance and Rcadia was named 2009 Best New Radiology Vendor by AuntMinnie.com.
Separately, the company has also been granted ISO 9001 & ISO 13485 designation for meeting quality management system standards for medical device manufacturing.
"The CE mark is an important milestone in Rcadia’s program to advance the practical application of coronary CT angiography,” said Shai Levanon, President and CEO of Rcadia. “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.”