FDA clears Siemens’ Symbia Intevo integrated SPECT and CT system

Siemens Healthcare has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Symbia Intevo—the world’s first xSPECT system, which combines the high sensitivity of single-photon emission computed tomography (SPECT) with the high specificity of CT. Completely integrating data from both modalities, Symbia Intevo generates high resolution and, for the first time ever, quantitative images. Symbia Intevo demonstrates Siemens’ innovation and competitiveness—key components of the Healthcare Sector’s Agenda 2013 two-year initiative.

Higher resolution frame of reference
In conventional SPECT/CT imaging, the SPECT image has always been reconstructed using SPECT's low-fidelity frame of reference. For this reason, the CT resolution has been downgraded dramatically to the level of SPECT to enable the mechanical fusion of both datasets. Siemens’ new xSPECT modality reconstructs both the SPECT and CT portions of the image using the high CT frame of reference for precise, accurate alignment that facilitates the extraction and deep integration of medically relevant information. This ability is also the basis for differentiating between tissue boundaries in bone imaging. With the xSPECT Bone feature, physicians can provide additional support for detection and distinguishing between cancerous lesions and degenerative disorders.

First truly quantitative SPECT
Symbia Intevo’s precise alignment of SPECT and CT provides physicians with essential volumetric information from the CT scan, enabling accurate, consistent and reproducible quantification—a numerical indication of a tumor’s level of metabolic activity. With the xSPECT Quant feature, the physician can apply quantitative information to aid in the assessment whether a patient's course of treatment has regressed, stabilized or grown—an assessment that is difficult to make with a purely visual assessment of the tumor.

Reduced CT dose
While Symbia Intevo uses more CT data than ever before, Siemens is still able to limit patient dose by offering combined applications to reduce exposure (CARE). Unique to Siemens, these applications include the CARE Dose4D technique, which can reduce patient CT radiation dose by up to 68 percent (2).

Increased productivity and throughput
Symbia Intevo also offers applications to improve productivity and patient throughput. For example, Siemens’ AUTOFORM collimator—a standard feature on Symbia Intevo—captures up to 26 percent more counts, or photons that are generated from radiotracer activity as compared to conventional collimators (2). This increased number of counts potentially reduces image acquisition time for increased patient throughput.

1) Symbia Intevo and xSPECT are not commercially available in all countries. Due to regulatory reasons, their future availability cannot be guaranteed. Please contact your local Siemens organization for further details.

2) Based on competitive literature available at time of publication. Data on file.

Launched in November 2011, Agenda 2013 is the initiative of the Siemens Healthcare Sector to further strengthen its innovative power and competitiveness. Specific measures, which will be implemented by the end of 2013, have been defined in four fields of action: innovation, competitiveness, regional footprint, and people development.

The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 51,000 employees worldwide and operates around the world. In fiscal year 2012 (to September 30), the Sector posted revenue of 13.6 billion euros and profit of around 1.8 billion euros. For further information please visit: www.siemens.com/healthcare.