InfraReDx Inc.

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InfraReDx gets FDA nod for hybrid imaging device

The Food and Drug Administration gave InfraReDx Inc. 510(k) clearance for the company's LipiScan IVUS coronary imaging system. The device employs both so-called "near-infrared" spectroscopy and intravascular ultrasound technology to give cardiologists a grayscale IVUS image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.