FDA Clears TomTec Medical Imaging Software Suite

Munich, Germany-based TomTec Imaging Systems GmbH has earned U.S. Food and Drug Administration (FDA) clearance for its TomTec-Arena software solutions. The software is a suite of clinical applications programmed to review, analyze and quantify medical image data in multiple dimensions (2-, 3-, and 4-D) and multiple modalities such as ultrasound, XA (X-ray angiography), MR (magnetic resonance) and NM (nuclear medicine).

TomTec-Arena combines TomTec’s entire cardiology and radiology application portfolio in one medical product. It can analyze standard 2-D DICOM (Digital Imaging and Communications in Medicine standard) as well as 2-D and 3-D proprietary data formats from all major ultrasound vendors.

The software suite features a variety of automated solutions for 2-D and 3-D volume measurements and strain imaging. It is designed to provide highly reproducible and reliable results, which support the clinical decision making process to assess subclinical deteriorations of the myocardium and to monitor left ventricular remodeling throughout the course of heart failure therapy.

The suite is available as a standalone workstation or network configuration in combination with Image-Arena. Image-Arena offers image management with a patient database, archiving and import/export functionality as well as connectivity and routing services. A full range of reporting solutions complement the product portfolio.

TomTec-Arena is also available as an integrated version within many picture archiving and communication system (PACS) and electronic medical record (EMR) systems on the market without the need of a separate server.

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

TomTec develops diagnostic medical imaging applications and cardio PACS solutions.