FDA clears 3D echo software

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TomTec Imaging Systems has received FDA 510(k) clearance for its 4D MV-Assessment 2.0 software, which uses 3D echocardiography for the analysis of the mitral valve.

According to the Munich-based company, its 4D MV-Assessment 2.0 derives static and dynamic measurements of the mitral valve apparatus, and it displays the non-planar, 3D geometry of the mitral valve for treatment of mitral valve disease.