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FDA Clears New System to Perform Simultaneous PET, MRI Scans
Date:6/10/2011

antly 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 http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm200086.htm

FDA: PET Scans http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Amanda Sena; 301-796-0393
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SOURCE U.S. Food and Drug Administration
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