Cleerly is launching its Cleerly Ischemia software, which recently received U.S. Food and Drug Administration (FDA) 510(k) medical device clearance.
The software is an automated machine learning-based decision support tool. It is intended to be a diagnostic aid for patients undergoing coronary CT angiography (CCTA) analysis using Cleerly Labs software. Cleerly Ischemia determines the likely presence or absence of coronary vessel ischemia based on quantitative measures of atherosclerosis, stenosis, and significant vascular morphology from CCTA images.
The company said that a Category 1 CPT code is available for the work performed in association with Cleerly Ischemia analysis, which is only available by prescription. Cleerly also noted that interested patients should consult with their physician.
