NordicNeuroLab Receives 510(k) Clearance for nordicICE® Perfusion/DCE Software

June 9, 2009 (Bergen, Norway) – NordicNeuroLab (NNL), a global market leader in developing products for functional imaging, announced today that the Food and Drug Administration (FDA) has issued 510(k) approval for market clearance of the nordicICE Perfusion/Dynamic Contrast Enhanced (DCE) Module®. The approval denotes that the FDA has officially cleared the Perfusion/DCE module of nordicICE software for analysis of MR perfusion and contrast agent permeability. With this latest clearance, the company completes its offering of high-grade, FDA approved analysis and post-processing software for functional MR imaging and confirms its leading position in this growing market.

nordicICE® is NordicNeuroLab’s main software framework dedicated to the clinical use of functional MR imaging methodologies such as BOLD, Diffusion/DTI, and Perfusion. BOLD and Diffusion/DTI modules of nordicICE received FDA clearance in November 2008, while nordicICE Perfusion/DCE Module is the latest addition to NordicNeuroLab’s extensive portfolio of FDA approved software solutions for functional imaging. This comprehensive product offering assures that clinical users can easily find an ideal solution from a single vendor to meet their specific needs when it comes to functional imaging.

"We are extremely pleased to receive the clearance and very excited to offer MR perfusion and DCE analysis capabilities to our clinical users in the U.S. and worldwide,” said Tormod Thomsen, NordicNeuroLab’s CEO. “Clinical interest in MR perfusion and dynamic contrast enhanced MR has been growing tremendously over the past years since these imaging techniques have been shown to provide new insights into the pathophysiology of tissues, with direct application in assessment of brain tumors and effects of stroke.”

With nordicICE Perfusion Module, a user can create high-quality perfusion maps from dynamic contrast enhanced MRI (T1 or T2/T2* weighted) images in seconds. The combination of a user-friendly interface, state-of-the-art methods and fast processing ensures maximum productivity without loss of quality. Furthermore, for the clinical workflow nordicICE Perfusion Module allows for “one-button” perfusion analysis using pre-defined settings. The nordicICE DCE Module produces high-quality maps of several contrast agent permeability-related parameters from dynamic contrast enhanced MRI images using state-of-the-art methods. It is based on the same user-friendly interface as the nordicICE Diffusion Module, allowing for easy integration of results of perfusion and diffusion imaging studies.

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About NordicNeuroLab:
NordicNeuoLab, an international company headquartered in Bergen, Norway, develops, manufactures and supplies high-quality products for MRI, with a special focus on the fast growing field of functional imaging. NordicNeuroLab’s product line features a seamlessly integrated set of hardware and software components, which can also be used separately to simplify the complex operations associated with fMRI. All of our products have been designed and developed in close collaboration with both research and clinical groups. NordicNeuroLab is active worldwide and has its own facilities for Sales and Support in Europe and United States.

For more information contact info@nordicneurolab.com