InfraReDx Inc. added the European Union to its market for the LipiScan IVUS coronary imaging system.

The Burlington, Mass.-based company won CE Mark approval for the device, which employs both so-called "near-infrared" (NIR) spectroscopy and intravascular ultrasound (IVUS) technology to give cardiologists a grayscale image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.

The data enables cardiologists to both visualize coronary plaques to guide stent placement and determine whether the build-ups are comprised of the fatty plaques that complicate stenting procedures and patients’ recovery, according to a statement from the company.

The company said LipiScan IVUS is the first and only CE Mark approved product to pair NIR spectroscopy and IVUS technology into one system.

The FDA granted InfraReDx 510(k) clearance for the LipiScan IVUS system in June 2010 and began marketing the device later that year. The European launch is expected in the coming months, the company said.

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

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• Biomerix lands two device licenses by Health Canada
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• SBi’s Star total ankle replacement wins coverage in Washington, Oregon and Alaska
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• FDA classifies hemorrhoid prevention pressure wedge
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