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Siemens' New Biograph mCT PET*CT System Receives FDA Clearance
[February 17, 2012]

Siemens' New Biograph mCT PET*CT System Receives FDA Clearance


(ENP Newswire Via Acquire Media NewsEdge) ENP Newswire - 17 February 2012 Release date- 15022012 - Malvern, Pa - Siemens Healthcare has announced that the Food and Drug Administration (FDA) recently cleared the features associated with the new Biograph mCT positron emission tomography/computed tomography (PET*CT) scanner.



The new Biograph mCT enables precise measurement of metabolic processes and data quantification, including the assessment of neurological disease and cancerous tissue, as well as cardiac blood flow (perfusion). Technological innovations and intelligent software solutions within the new PET*CT result in accurate, consistent quantitative assessments. With the new Biograph mCT, which was unveiled last November at the 2011 annual meeting of the Radiological Society of North America (RSNA) in Chicago, Siemens offers yet another paradigm in PET*CT, bolstering the company's innovative power and competitiveness - a goal of its recently announced global initiative, Agenda 2013.

Accuracy and reproducibility in PET quantification enable the physician to more precisely characterize cancer lesions, which permits better staging and monitoring of changes in activity over time for more accurate assessment of treatment response. The ability to measure absolute myocardial blood flow in cardiology allows the physician to more accurately assess multi-vessel disease. In neurology, noninvasive assessment of the brain can potentially improve the diagnosis and management of patients who present with signs of dementia.


Siemens implemented these clinical requirements in the new Biograph mCT, which supports physicians in treating many neurological, oncological and cardiological diseases - through earlier, more precise diagnosis, as well as in therapy planning and precise monitoring of disease progression. With this additional information, physicians are better equipped to make decisions with high certainty and initiate more patient-tailored therapies.

The latest Biograph mCT can provide additional information to aid in the diagnosis of dementia,-1 which affects an estimated 35.6 million people worldwide and may affect as many as 115.4 million people by 2050. Alzheimer's disease is the most frequently diagnosed form of dementia.-2 Technical innovations With conventional technology, clinicians face the issue of variability in quantitative results due to software and hardware challenges. Engineered to overcome these technical and procedural obstacles, the new Biograph mCT offers accurate and reproducible quantification in PET*CT imaging by ensuring optimization of each element of the imaging chain - with an emphasis on the finest volumetric image resolution on the market,-1 daily system calibration, accuracy of attenuation correction using automated co-registration algorithms, and more automated, user-independent and reproducible standardized uptake value (SUV) calculation methods for daily clinical practice.

The new Biograph mCT incorporates Siemens' unique OptisoHD (High-Definition) Detector System, which features a fine volumetric resolution1 of only 87 mm.-3 Other innovative technologies include Time of Flight (TOF) and HD*PET, ensuring fast, precise images with minimum radiation dose.

With Siemens Quanti*QC, daily system normalization can be performed overnight, calibrating and tuning the system to precisely the right specifications, facilitating consistent and optimal performance, day after day.

Siemens Molecular & Anatomical Registration Technologies (SMART) address the traditional problems of inherent scanner drift and inaccurate attenuation correction through misregistration of anatomical and functional images. To facilitate accurate attenuation correction and reliable quantitative measurements, the new Biograph mCT's unique patient handling system virtually eliminates differential deflection. The system also features Auto Cardiac Registration that automatically aligns CT and PET heart images and reduces variability between users. Additionally, SMART offers a new form of attenuation correction for neurological images that no longer requires CT data.

Advanced syngo clinical applications provide essential tools to obtain quantifiable measurements in neurology, cardiology and oncology imaging. SUVpeak, new in the syngo.via oncology engine, provides consistent, reproducible quantitative assessments of hot spots. Myocardial blood flow (MBF) can be used as an absolute quantification method to assess balanced disease in all areas of the heart. Additionally, a new quantitative tool in neurology - the syngo.PET Neuro DB Comparison application as part of the syngo.mCT Neurology engine - automatically registers brain data to a FDG PET normal database to aid in the assessment of neurological disorders.

The new Biograph mCT is expected to ship in May 2012.

-1Products are still under development and not commercially available yet. Future availability cannot be ensured.

-2 Source: World Alzheimer's Report: Alzheimer's Disease International.

-3 Based on competitive literature available at time of publication. Data on file.

Launched by Siemens Healthcare Sector in November 2011, Agenda 2013 is a two-year global initiative to further strengthen the Healthcare Sector's innovative power and competitiveness. Specific measures will be implemented 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 2011 (to September 30), the Sector posted revenue of 12.5 billion euros and profit of around 1.3 billion euros. For further information please visit: www.siemens.com/healthcare.

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