FDA clears new Siemens PET/MRI scanner

FDA clears new system to perform simultaneous PET, MRI scans

The U.S. Food and Drug Administration today cleared the Siemens Biograph mMR system, the first device to simultaneously perform a positron emission tomography scan, commonly known as PET scan, and a magnetic resonance imaging (MRI) scan.

PET scans allow physicians to see how the organs and tissues inside the body are actually functioning by injecting a radioactive chemical tracer into the patient’s bloodstream. MRI uses magnetic fields and radiowaves to produce detailed images of organs, soft tissues, bone and other internal body structures.

Previously, physicians could use a PET and computer tomography (CT) scanner to image the body. Advantages of the Siemens Biograph mMR system over current systems include simultaneous imaging, reduced radiation dose, and increased soft tissue contrast.

“The Siemens PET/MRI system allows two tests to run simultaneously without having to move the patient to a different scanning system,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health. “Minimizing changes in a patient’s position between tests allows physicians to compare images more easily and helps them get the most accurate information possible.”

The Biograph uses MRI rather than CT to produce detailed images of the internal structures of the body. Because MRI makes images based mainly on the concentration of water in the body, it can produce greater detail of nearly all the internal structures of the body as compared with CT, which uses X-rays to make images. This could provide the physician with additional information about a patient’s condition.

Additionally, the Biograph mMR system allows physicians to acquire images at a significantly lower radiation dose compared to a PET/CT system. Although the radiation dose from the PET exam remains unchanged, MRI does not use ionizing radiation, so the entire ionizing radiation dose from the CT scan is eliminated. The decreased radiation dose is especially significant for sensitive populations, such as children or patients who are receiving multiple scans.

The FDA cleared the Siemens system based on bench tests that compared the device with a predicate PET/CT device. The Biograph mMR system is indicated for anyone who needs diagnostic PET or MRI imaging. However, people with pacemakers, defibrillators or other implanted electronic devices should not be scanned with the Biograph mMR system unless those devices are specifically indicated for use in the MRI environment, because the strong magnetic fields of the MRI system may interfere with those devices.

The Siemens BioGraph mMR system is manufactured by Siemens Medical Solutions, Malvern, Pa.

For more information:
FDA: MRI Scans
FDA: PET Scans



3 thoughts on “FDA clears new Siemens PET/MRI scanner

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  2. Siemens Introduces Next-Generation PET-CT System, Biograph mCT
    by JAN SINNIGE on Nov 30, 2011 • No Comments
    Siemens Healthcare introduced its next-generation Biograph mCT, a positron emission tomography-computed tomography (PET-CT) scanner at the annual meeting of the Radiological Society of North America (RSNA) in Chicago. The new Biograph mCT incorporates the Siemens OptisoHD (High-Definition) Detector System, which will feature a volumetric resolution of 87 mm3. Other technologies include Time of Flight and High-Definition PET, ensuring fast, precise images with minimum radiation dose. This enables precise measurements of metabolic processes including the assessment of neurological disease, cancerous tissue and cardiac blood flow.

    In this device the diagnosis of neurodegenerative diseases, such as dementia, got a special focus. With potential new PET biomarkers, reliable imaging of beta-amyloid plaque in the brain may be possible, providing information to aid in the diagnosis of dementia, potentially slowing disease progression through earlier care.

    Jerry Froelich, MD, FACR, Loken Professor of Radiological Sciences at the University of Minnesota is cited in the press release:

    “By bringing accuracy and reproducibility to quantification in PET, we can more precisely characterize cancer lesions, allowing for better staging and monitoring of the change in activity over time for more accurate assessment of treatment response. In cardiology, being able to measure absolute myocardial blood flow allows for accurate assessment of multi-vessel disease. In neurology, the potential is huge. The ability to noninvasively assess the brain can improve the diagnosis and therefore management of patients presenting signs of Alzheimer’s disease.”

    The syngo clinical applications provide essential tools to obtain quantifiable measurements in neurology, cardiology and oncology imaging. SUVpeak, new in the syngo.via oncology engine, provides consistent and reproducible quantitative assessments of hot spots. Myocardial Blood Flow (MBF) can be used as a quantification method to assess disease in all areas of the heart and a new quantitative tool in neurology, the syngo.PET Neuro application, automatically registers brain data to a normals database to assist in the assessment of neurological disorders.

    The new Biograph mCT is currently under review by the FDA.

    Press release: Siemens’ New Biograph mCT PET-CT System Enables Greater Diagnostic Certainty

    Flashback: Siemens Biograph mMR MR/PET Tomograph Gets U.S. Clearanc

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