FDA Clears Siemens’ New ACUSON SC2000 Ultrasound System, Release 2.0

Malvern, Pa., January 11, 2012– Siemens Healthcare has announced that Release 2.0 of the ACUSON SC2000™ volume imaging ultrasound system has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the United States. This latest version of the ACUSON SC2000 system – Siemens’ pioneering premier echocardiography system – elevates volume imaging in echocardiography to a new level, delivering significant performance and imaging enhancements to improve workflow and patient outcomes. Release 2.0 offers a host of new applications, including the quantification of the 3D proximal isovelocity surface area (PISA) to assess the severity of valvular disease and volumetric color Doppler. Other applications include a comprehensive package for automated left ventricle analysis (LVA), which enables the auto-detection and tracking of volume contours, and Siemens’ exclusive IN Focus coherent image-forming technology, which yields a high level of image uniformity and clinical detail. Release 2.0 supports volumetric intracardiac echocardiography (ICE), enabling integration of the ACUSON AcuNav™ ultrasound catheters.

Through the advanced volume analysis application known as eSie PISA™ – an industry first from Siemens – the user of the ACUSON SC2000 system can obtain semi-automatic quantification of the PISA from 4D color Doppler data. This quantification enables the clinician to eliminate the current practice of 2D PISA assumptions and improve measurement accuracy by using volumetric color analysis for valvular regurgitation, which affects millions of people worldwide.

source: Siemens