TomTec receives FDA 510(k) clearance for 2D Cardiac Performance Analysis© MR
Munich, Germany – April 20th 2012 – TomTec Imaging Systems GmbH announces the FDA 510(k) clearance for its new 2D Cardiac Performance Analysis MR software solution.
2D Cardiac Performance Analysis MR, in short 2D CPA MR, is a vendor independent software solution for the quantification of myocardial function with “cardiac MR cine images”. 2D CPA MR presents a novel method to analyze myocardial deformation from routine CMR images, which have been acquired as part of a conventional cardiovascular MR examination – no time consuming tagging is necessary.
Based on innovative feature tracking technology, 2D CPA MR calculates regional and global velocity, displacement, strain, and strain-rate parameters.
With minimal user interaction, the manual trace of a single endocardial contour serves as initial pattern from which the system tracks the displacement of myocardial structures over the length of a complete heart cycle. The software tracks endo- and epicardium, and describes left ventricular deformation in terms of longitudinal, radial and circumferential components.
“2D CPA MR provides incremental information regarding left ventricular deformation and enhances the diagnostic possibilities. With 2D CPA MR, even a comprehensive strain analysis can be fully integrated into your clinical routine workflow” says Rolf Baumann TomTec’s Vice President of Clinical Products and Innovations.
Since more than 20 years TomTec Imaging Systems GmbH, with headquarters located in Munich, Germany holds an inventive leadership position in the field of diagnostic medical imaging applications and Cardio PACS solutions. The company maintains close working relationships with many leading universities and device manufacturers around the world.
TomTec’s product portfolio encompasses a wide range of 2D and 3D/4D technologies for visualization, analysis, reporting and archiving of multimodality imaging data. TomTec solutions are applicable in the fields of Adult- and Pediatric Cardiology as well as Obstetrics, Gynaecology, Radiology, and Vascular Imaging. Visit TomTec's web site at www.tomtec.de