FDA clears TomTecs cardiac MR analysis software

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TomTec Imaging Systems has received FDA 510(k) clearance for its 2D Cardiac Performance Analysis MR (2D CPA MR) software.

2D CPA MR is vendor-independent software for the quantification of myocardial function with cardiac MR cine images, allowing analysis of myocardial deformation from routine cardiac MR. The software uses feature tracking technology to calculate regional and global velocity, displacement, strain and strain-rate parameters.

The manual trace of a single endocardial contour serves as an initial pattern from which the system tracks the displacement of myocardial structures of the length of a heart cycle, requiring minimal user interaction, according to Munich-based TomTec. 2D CPA MR tracks endo- and epicardium, as well as describes left ventricular deformation in terms of longitudinal, radial and circumferential components.