Rcadia Medical Imaging Ltd. has received CE Mark approval for its algorithm-based software tool that detects for signs of coronary artery disease.
The Newton, Mass.-based company manufactures the COR Analyzer, which quickly triages patients who come into an emergency room with chest pains to determine if there are signs of coronary artery disease. The software uses an algorithm to rapidly processes images taken during coronary CT angiography (cCTA) studies and produces real-time analysis to determine whether there are lesions in coronary arteries.
The product is specifically for use in emergency departments and radiology settings and functions as an add-on to all models of cCTA machines.
Rcadia already won 510(k) clearance to sell the COR Analyzer System in the U.S. and will now be able to sell the product throughout the European Union, according to a prepared release.
In 2008, Rcadia raised a $3.3 million round from Bioventures Investors of Cambridge, Mass.