Heart Disease
FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx, Inc. - a Novel Spectroscopy System for the Identification of Lipid Core Containing Plaques of Interest in the Coronar
Published in Medical Letter on the CDC and FDA, May 18th, 2008
InfraReDx, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its catheter-based LipiScan(TM) Coronary Imaging System. The LipiScan device uses near-infrared spectroscopy to identify lipid core containing plaques of interest in the coronary arteries in patients already undergoing cardiac catheterization. Such plaques, which cannot be detected by commonly used tests such as a treadmill examination and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks.
The availability of this novel tool culminates a decade-long biomedical engineering effort to...
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