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

HAIFA, Israel, Sept. 26 Rcadia Medical Imaging, Ltd.,developer of novel computer-aided diagnostic software, has received a secondU.S. Federal Food and Drug Administration (FDA) clearance to market its CORAnalyzer family of products, which assists in triaging patients for coronaryartery disease (CAD). The new approval includes segmentation of the coronarytree with no human intervention and automatic detection of pathologies in themain coronary arteries.

Coronary artery disease is a major underlying cause for acute chest painin Emergency Department (ED) patients. Annually, more than 5 million USpatients present in the ED with acute chest pain. CT Angiography (CTA) isbeing rapidly adopted to triage patients in EDs across the U.S. Rcadia's CORAnalyzer quickly identifies coronary artery disease and helps exclude patientswithout coronary arterial disease with a high negative predictive value (NPV).Rcadia's COR Analyzer system uses proprietary image processing algorithmsallowing a no human intervention analysis of Coronary CTA studies tocharacterize patients. While improving ED workflow, it can lead to a morerapid diagnosis, enabling appropriate treatments and avoiding unnecessarydelays and invasive tests in patients who do not have coronary artery disease.

"The COR Analyzer is expected to assist the ED staff in reading CoronaryCTA studies 24/7. Prioritizing patients with CAD, identifying andcharacterizing pathologies will save time and improve workflow in the ED aswell as the radiology and cardiology departments," commented Shai Levanon,Rcadia CEO.

Coronary CTA studies are sent from the CT scanner to the COR Analyzer andanalyzed without human intervention. The COR Analyzer is highly reliable inruling out coronary artery disease. In analyzing over 350 CTA studies,generated by all four CT manufacturers, the Rcadia COR Analyzer successfullyidentified coronary artery disease and had a high NPV of over 97%.

"As a result of the COR Analyzer high negative predictive value we arecurrently finalizing testing of the product and strongly hope to start usingit to triage cases that need to be read, alerting the reader which patientsare most likely to have coronary arterial disease. Since COR Analyzerautomatically marks pathologies; this in turn will make reading casessignificantly faster even for the experienced radiologists." added NathanPeled, MD, Head Department of Radiology at the Lady Davis Carmel MedicalCenter in Haifa.

SOURCE Rcadia Medical Imaging, Ltd.

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