News | September 25, 2007

Rcadia's COR Analyzer Family of Products Receives Second FDA Clearance

September 26, 2007 - Diagnostic software maker Rcadia Medical Imaging Ltd. received a second FDA clearance to market its COR analyzer family of products, which assists in triaging patients for coronary artery disease (CAD).
The new approval includes segmentation of the coronary tree with no human intervention and automatic detection of pathologies in the main coronary arteries.
Coronary artery disease is a major underlying cause for acute chest pain in emergency department (ED) patients. Annually, more than 5 million U.S. patients go to the ED with acute chest pain. CT angiography (CTA) is being rapidly adopted to triage patients in EDs across the U.S. Rcadia’s COR analyzer quickly identifies coronary artery disease and helps exclude patients without coronary arterial disease with a high negative predictive value (NPV). Rcadia's COR analyzer system uses proprietary image processing algorithms allowing a no human intervention analysis of coronary CTA studies to characterize patients. While improving ED workflow, it can lead to a more rapid diagnosis, enabling appropriate treatments and avoiding unnecessary delays and invasive tests in patients who do not have coronary artery disease.
Coronary CTA studies are sent from the CT scanner to the COR analyzer and analyzed without human intervention. The company says the COR analyzer is highly reliable in ruling out coronary artery disease. In analyzing more than 350 CTA studies, generated by all four CT manufacturers, the Rcadia COR analyzer successfully identified coronary artery disease and had a high NPV of more than 97 percent.
"As a result of the COR analyzer high negative predictive value we are currently finalizing testing of the product and strongly hope to start using it to triage cases that need to be read, alerting the reader which patients are most likely to have coronary arterial disease," said Nathan Peled, M.D., head of the department of radiology at the Lady Davis Carmel Medical Center in Haifa, Israel. "Since COR analyzer automatically marks pathologies; this in turn will make reading cases significantly faster even for the experienced radiologists."

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