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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Orthocon Inc., a privately-held therapeutic device company, today announced that DEKRA and Health Canada have cleared its HEMASORB Absorbable Bone Hemostat Matrix for clinical use and sale in Europe and Canada.
Read more - Hologic wins FDA clearance to include body composition assessment in bone sensity systems
Hologic Inc. (NSDQ:HOLX) won FDA clearance to incorporate the U.S. National Health and Nutrition Examination Survey (NHANES) Whole Body Reference Data into its Discovery dual x-ray absorptiometry (DXA) systems. These body composition values are useful to healthcare professionals in their management of diseases and conditions when the disease or condition itself, or its treatment, can affect the relative amounts of fat and lean tissue.
Read more - Biomerix lands two device licenses by Health Canada
Biomerix Corp. received two Class III Medical Device Licenses by Health Canada for its REVIVE and ASSURE Hernia Repair Meshes. REVIVE and ASSURE surgical meshes feature the Biomerix Biomaterial, a proprietary, biointegrative, synthetic tissue scaffold.
Read more - SBi’s Star total ankle replacement wins coverage in Washington, Oregon and Alaska
Small Bone Innovations Inc. announced that LifeWise health plans in Washington State, Oregon and Alaska, covering 1.6 million members, have revised their coverage policies to cover the company’s STAR total ankle. The STAR ankle is the only total ankle replacement system (TAR) cleared through the U.S. Food and Drug Administration’s (FDA) rigorous pre-market approval process (PMA).
Read more - FDA classifies hemorrhoid prevention pressure wedge
The FDA is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.
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