NEWTON, Mass., March 8 /PRNewswire/ -- 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.”
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 significant lesions (more than 50 percent 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 numerous clinical studies to date as well as in routine clinical use, the COR Analyzer System has demonstrated high negative predictive value (over 95 percent). 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 percent compared with expert readers.
Additional information on the COR Analyzer is available from Rcadia at 617-453-2064.
About Rcadia Medical Imaging
Rcadia Medical Imaging develops and markets automated image processing software products for blood vessel analysis in patients with suspected cardiovascular disease. The company’s first FDA-cleared product, the COR Analyzer® System, provides fully automated, real-time analysis of Coronary CT angiography to enable the practical application of cCTA in detecting coronary artery disease. The COR Analyzer improves the utility of Coronary CTA studies in the emergency department to triage chest pain patients and optimizes workflow in cardiology and radiology departments. Learn more at www.rcadia.com.
SOURCE Rcadia Medical Imaging