Healthcare Industry News:  vascular imaging 

Devices FDA

 News Release - February 15, 2011

TomTec Receives FDA 510(k) Clearance for 4D MV-Assessment(R) 2.0 Software- the Solution for Improved Diagnostic Confidence in Mitral Valve Diagnostic Using 4D Ultrasound

MUNICH, Germany--(Healthcare Sales & Marketing Network)-- TomTec Imaging Systems GmbH announces the FDA 510(k) clearance for its new 4D MV-Assessment© 2.0 product. The software uses real-time three-dimensional echocardiography (3DE) for the analysis of the mitral valve. Within less than a minute, 4D MV-Assessment© 2.0 derives static and dynamic measurements of the entire mitral valve apparatus. This solution is tailored to clinical setups where precise diagnosis meets the demand of topmost efficiency.

Automated features and a “smart workflow” have considerably shortened analysis times and supply users with accurate information for their clinical decision in seconds.

Understanding the non-planar, three-dimensional geometry of the mitral valve (MV) has been shown to be an important aspect regarding the treatment of mitral valve disease. Such as better understanding of geometric determinants in cases of functional mitral regurgitation can improve individualized surgical planning and thus lead to better outcomes.

“We developed the 4D MV-Assessment© software considering input from leading clinical partners around the world, with an emphasis on user-friendliness and accuracy. Receiving FDA clearance for 4D MV-Assessment© is a major step for us. We have proven again that TomTec offers solutions which are ’One-Step-Ahead’, says Frank Schlau, TomTec’s Chief Marketing Officer.”

About TomTec

Since 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

Source: TomTec Imaging Systems

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