Technology | June 11, 2009

NordicNeuroLab Gets FDA Gives 510(k) Clearance for MR Perfusion Solution

June 11, 2009 - NordicNeuroLab said this week the FDA issued 510(k) approval for nordicICE Perfusion/Dynamic Contrast Enhanced (DCE) Module, software for analysis of MR perfusion and contrast agent permeability.

With this latest clearance, the company completes its offering of high-grade, FDA-cleared 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 2009, 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.

With nordicICE Perfusion Module, a user can create reportedly 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 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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