FDA greenlights InfraReDx NIR/IVUS combo catheter

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The FDA has granted 510(k) clearance for the LipiScan near-infrared (NIR) and intravascular ultrasound (IVUS) coronary imaging system from InfraReDx.

The NIR spectroscopy identifies the chemical content of the plaques; the IVUS provides an image of plaque structure and stent features, according to the Burlington, Mass.-based company.

InfraReDx said it expects a commercial launch of the system in the U.S. by the year’s end and anticipates a CE mark for distribution across Europe in 2011.