TomTec receives FDA 510(k) clearance for its latest version of TomTec-Arena software


TomTec has announced FDA 510(k) clearance for its TomTec-Arena software solution. TomTec-Arena is a suite of clinical applications to review, analyse and quantify medical image data in multiple dimensions (2D and 3D/4D) and multiple modalities such as ultrasound, X-ray angiography, magnetic resonance and nuclear medicine imaging.

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

The software suite features a variety of automated solutions for 2D and 3D volume measurements and strain imaging. Highly reproducible and reliable results 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.

TomTec-Arena 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 (PACS) and electronic medical record (EMR) systems on the market without the need of a separate server, thus extending existing hospital IT into a powerful diagnostic environment without adding complexity for the IT department.

“Time efficient image review and automated measurements that are highly reproducible help improve diagnostic quality while minimising daily workload for every single user”, says Gregor Malischnig, chief marketing officer at TomTec. “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 is introducing the TomTec-Arena software at the American College of Cardiology meeting (14–16 March, San Diego, USA).