FDA Clears Siemens' New Ultrasound System

Siemens Healthcare’s latest release of the ACUSON SC2000 volume imaging ultrasound system has received FDA 510(k) clearance, the company announced.

The Release 2.0 of the company’s echocardiography system is now commercially available in the U.S., and is the first ultrasound system that enables production of real-time, full-volumetric cardiac images in one heart cycle, the company said.

New applications aimed at providing performance and imaging enhancements to improve workflow and patient outcomes include the quantification of the 3-D proximal isovelocity surface area (PISA) to assess the severity of valvular disease and volumetric color Doppler.

It also includes a comprehensive package for automated left ventricle analysis and Siemens’ IN Focus coherent image-forming technology, which processes information at 2.88 gigabytes per second, making it the fastest echocardiography system, according to the company. This allows users to focus on the entire field of view, revealing more detailed information in one image.

Release 2.0 supports volumetric intracardiac echocardiography, which enables the integration of the ACUSON AcuNav ultrasound catheters, the company said. Electrophysiologists and interventional cardiologists can obtain ultrasound images from within the heart in real time, the company said.