Germany-based TomTec Imaging Systems has received 510(k) approval from the US Food and Drug Administration (FDA) for its new version of TomTec-Arena software solution.


TomTec-Arena is a suite of clinical applications developed to review, analyze and quantify medical image data in multiple dimensions (2D & 3D/4D) and multiple modalities such as ultrasound, XA, MR and NM.

TomTec Imaging Systems chief marketing officer Gregor Malischnig said: "Time efficient image review and automated measurements that are highly reproducible, help improve diagnostic quality while minimizing daily workload for every single user.

"Over the past months we invested a lot of research and development to shape out a whole new generation of clinically validated applications that are available in more than 14 languages and regulatory cleared for most countries".

Featuring a variety of automated solutions for 2D and 3D volume measurements and strain imaging, the software suite is available as a standalone workstation or network configuration in combination with Image-Arena.

Image-Arena provides image management with a patient database, archiving and import/export functionality, in addition to connectivity and routing services.

TomTec-Arena integrates firm’s entire cardiology and radiology application portfolio in one medical product, which can analyze standard 2D DICOM as well as 2D and 3D proprietary data formats from all major ultrasound vendors.

In addition, it is available as an integrated version within many PACS and EMR systems, eliminating the need of a separate server.

Image: FDA has granted approval for new TomTec-Arena software solution. Photo: courtesy of Stuart Miles/