FDA approves application for Siemens BiographmMR system

The US Food and Drug Administration (FDA) recently approved a 510(k) listing application for the Siemens Medical BiographmMR system. Approval approval indicates that the system can be successfully placed on the market. Customers can now start using this new system for routine clinical applications. BiographmMR is the world's only fully integrated molecular MR system with simultaneous data acquisition technology that simultaneously acquires both magnetic resonance (MR) and positron emission tomography (PET) data.

Since November 2010, several sets of BiographmMR systems have been installed in several university affiliated hospitals for clinical research. This innovative system is expected to show great clinical value in the fields of neurology, oncology and cardiology. One of the systems was installed in the Department of Radiology of the Affiliated Hospital of the University of Tübingen, Germany. Dr. Claus D. Clausissen, clinical director of the Department of Diagnostics and Interventional Radiology, predicts that the system will have higher accuracy in diagnosis and treatment planning than MRI and PET, respectively, due to its synchronized data acquisition capabilities. Claussen also pointed out that "this new technology will benefit patients, because synchronous molecular MR technology will provide us with more information for personalized treatment. In addition, extraordinary image quality will help us diagnose early. And understand the highly relevant diseases."

Not long ago, the Siemens Medical BiographmMR system passed the CE certification, enabling EU customers to start putting the new system into routine clinical applications. Earlier this year, Siemens Medical was awarded the 2011 North American New Product Innovation Frost & Sullivan Award for its BiographmMR system. In addition, BiographmMR won the “Red Dot” design award in the “Life Science and Medicine” category for its outstanding design. The Red Dot Design Award is the largest and most prestigious design award in the world. BiographmMR is the world's only fully integrated molecular MR system with MR and PET simultaneous data acquisition technology.

BiographymMR built the PET detector inside the 3T magnetic resonance for the first time. This design brings innovation in life image diagnosis, and truly achieves simultaneous acquisition of information at various levels of anatomy, function, physiology, and biochemistry. Now, the whole body MR and PET are fully integrated, the data truly achieves the perfect coincidence in space and time, can accurately grasp the metabolism and functional process, and help to better understand the true state of the physiological process, for systemic diseases. The in-depth understanding provides a striking detail display, and then proposes a new perspective on disease observation, develops new methods of treatment follow-up, and opens up new areas of scientific research. In the end, broaden human understanding of life.

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