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
“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