Siemens Healthcare has been granted FDA 510 (k) clearance for its Biograph mMR by the US Food and Drug Administration. The Biograph mMR is the first system in the world that allows simultaneous acquisition of data from Positron Emission Tomography (PET) and Magnetic Resonance (MR).
MR offers detailed functional and morphological data in soft tissue, while PET goes one step further and explores the human body at metabolism and cellular activity levels. The Biograph mMR helps users to create the function, location and metabolic activity of organs within a single image. It is capable of providing a total diagnostic picture and delivering technologies that help physicians to find better outcomes, effective diagnosis and efficient treatments.
The device permits biochemical, functional and anatomical imaging of a disease. It could be used in clinical applications for therapy planning, early identification and staging of malignancies and treatments. It can also be used in neurologic and oncologic applications where PET and MR have proved to be greatly beneficial.
According to Gregory Sorensen, MD and CEO of Siemens Healthcare in Canada and USA, this device is an innovative combination of two powerful modalities into one whole body system. He further stated that such potent diagnostic tools could usher in greater efficiency in the healthcare sector and can help enhance quality of health.
The first installation of the Biograph mMR was done in Germany’s Tuebingen University Hospital, Munich Technical University’s Klinikum rechts der Isaar and Massachusetts General Hospital in Boston, USA.
Professor Dr. Markus Schwaiger, Director at the Klinikum rechts der Isaar’s Nuclear Medicine Clinic, stated that they were utilizing the Biograph mMR to diagnose diseases at the beginning stage so that they could use the data to devise a therapy plan that totally focused on specific patient, and also to observe the progression of diseases. Moreover, they also planned to utilize the system for cancer follow ups in the future by decreasing radiation exposure.
Before the advent of the Biograph mMR, it was next to impossible to integrate the MR and PET technologies. The traditional PET detectors with Photomultiplier tubes were unusable in the MR system’s strong magnetic field. Moreover, space constraint inside the MR device proved to be one more obstacle. Hence in the past, MR-PET fusion imaging solutions were not done on the basis of simultaneous imaging but on sequential imaging of PET and MR data, which led to a considerable time lag.
Patients can be scanned by the Biograph mMR within 30 minutes for a whole body exam. The system is as compact as a standard high-field MR scanner and thus removes renovation expenses for facilities looking to replace old MRI system with the new Biograph mMR.