PRNewswire -- InfraReDx, Inc., a medical device company developing intelligent cardiovascular diagnostic imaging technologies, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the LipiScan™ IVUS Coronary Imaging System. LipiScan IVUS is the first cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to help cardiologists identify and characterize the plaques that complicate stenting and are associated with acute coronary events. The NIR spectroscopy identifies the chemical content of the plaques; the IVUS provides an image of plaque structure and stent features. The Company expects to conduct a broad commercial launch of the system within the U.S. by year-end 2010, and anticipates regulatory approval and launch in Europe during 2011.
