Siemens’ Biograph mMR system receives FDA clearance

4 July 2011

The US Food and Drug Administration (FDA) has granted Siemens Healthcare 510(k) clearance for the Biograph mMR.

The system can now be marketed to customers and it can be used 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.


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