Rcadia Medical Imaging has received the US Food and Drug Administration (FDA) 510(k) marketing clearance for an enhanced version of its COR Analyzer System, to assess coronary branch vessels in addition to main coronary arteries in patients with suspected coronary artery disease (CAD).
The COR Analyzer System automatically detects stenotic lesions in coronary arteries from Coronary CT Angiography (cCTA) studies.
The FDA clearance follows the recent publication of the first clinical study evaluating the COR Analyzer’s enhanced version.
The COR Analyzer System demonstrated a sensitivity of 92% and a negative predictive value of 97%. In the study, the system’s specificity was 70% and the positive predictive value was 48%.
Rcadia president and CEO Shai Levanon said the enhanced version expands the benefits of the COR Analyzer System as a powerful complement to cCTA in evaluating suspected CAD patients.
"By providing rapid detection of stenotic lesions our system enables expanded use of cCTA to enhance patient care and reduce unnecessary costs," Levanon said.