The U.S. Food and Drug Administration (FDA) recently granted Siemens Healthcare 510(k) clearance for the Biograph mMR. This clearance indicates that the system has been assessed prior to market placement.
Customers can now begin using the new system for routine clinical application. Biograph mMR is the world’s only fully integrated whole-body molecular MR with simultaneous magnetic resonance (MR) and positron emission tomography (PET) data acquisition. Since November 2010, several Biograph mMR systems have been installed in university hospitals for clinical research.
The innovative system is expected to be particularly valuable in the identification of neurological, oncological and cardiac conditions. One system is used in the department of radiology at the university hospital in Tuebingen, Germany. Prof. Dr. Claus D. Claussen, the clinical director of the department of diagnostic and interventional radiology at the hospital, expects greater precision compared to sequential MRI and PET exams, both in diagnostics and treatment planning due to acquiring the data simultaneously.
“Patients will benefit from this new technology, as simultaneous molecular MR will give us additional information for personalized therapy management,” stated Claussen. “Furthermore, the very good image quality will support us in the early diagnosis and understanding of highly relevant diseases.” Recently, Siemens Healthcare received the CE marking for the Biograph mMR system which allows customers in the European Union to begin using the new system for clinical routine application. Earlier this year, Siemens Healthcare received the 2011 North American Frost & Sullivan Award for New Product Innovation for the Biograph mMR. Furthermore, Biograph mMR was honored with the “red dot” for its high design quality in the category “Life Science and Medicine.” The red dot award is the world’s largest and most famous design competition.
The here mentioned product is not commercially available in all countries. Due to regulatory reasons its future availability in any country cannot be guaranteed. Please contact your local Siemens organization for further details.
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 48,000 employees worldwide and operates around the world. In fiscal year 2010 (to September 30), the Sector posted revenue of 12.4 billion euros and profit of around 750 million euros.
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