RevealDx has secured EU Medical Device Regulation (MDR) certification for its lung nodule software, RevealAI-Lung.
RevealAI-Lung characterizes lung nodules via a score the company calls the Malignancy Similarity Index (mSI). The software reduces time to diagnosis and false positives, according to the firm. It can be purchased directly from RevealDx or through its distributor, contextflow.
RevealAI-Lung is not yet cleared by the U.S. Food and Drug Administration, the company said.
