InfraReDx heart device gets FDA marketing approval

Wed, 09/01/2010 - 11:39am
Mass High Tech: The Journal of New England Technology

InfraReDx Inc., a Burlington-based medical device firm, has been granted clearance from the U.S. Food and Drug Administration to market its LipiScan IVUS Coronary Imaging System. The system is intended to be used by cardiologists for the purpose of identifying lipid core coronary plaques, linked to heart attacks after stenting.

With the FDA 510(k) clearance, InfraReDx noted in a press release today that it plans to commercially launch the coronary imaging system by the end of 2010, with additional plans to gain approval to launch the system in Europe in 2011.

The company noted in a press release that the LipiScan IVUS Coronary Imaging System is the “first cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy.” Its NIR spectroscopy identifies the chemical content of the plaque, while the intravascular ultrasound gives doctors and image of the plaque and stent.





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