Navigation Links
FDA Clears New System to Perform Simultaneous PET, MRI Scans

SILVER SPRING, Md., June 10, 2011 /PRNewswire-USNewswire/ -- 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

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;
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Single-Use Antibacterial Surgical Respirator
2. FDA Clears Test for Bacteria That Can Cause Serious Intestinal Disease
3. FDA Clears Mandometer® for the Treatment of Eating Disorders
4. FDA Clears Abbotts i-STAT® 1 Wireless Point of Care Testing System
5. FDA Clears Palatin Technologies IND Filing to Commence Clinical Studies for Asthma
6. FDA Clears Test to Help Patients With Kidney Transplants
7. FDA Clears First Diagnostic Radiology Application for Mobile Devices
8. FDA Clears GeNO LLCs Investigational New Drug Application for Clinical Trials With Its NITROSYL™ Inhaled Nitric Oxide System
9. FDA Clears Volpara™ Breast Imaging Software for Automatic Calculation of Volumetric Breast Density
10. FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain
11. FDA Clears Software Upgrade for Fenwal Plasma-Collection System
Post Your Comments:
(Date:10/12/2015)... the United States . By early next year, the ... the United States . By early next year, the ... The University of Texas MD Anderson Cancer Center, Elekta and Philips ... MRI-guided linear accelerator in the United States . ... non-clinical capacity. Royal Philips (NYSE: PHG ; ...
(Date:10/12/2015)... , Oct. 12, 2015  The Pharmacy ... of Harbor Compounding Pharmacy in Costa ... in recognition of the pharmacy,s commitment to meeting ... --> ... --> --> ...
(Date:10/12/2015)... PARK, Calif. , Oct. 12, 2015 ... R&D and Chief Scientific Officer of Asterias ... biotechnology company in the emerging field of ... Dealmakers webcast, sponsored in part by Asterias ... Dr. Lebkowski will discuss the progress to ...
Breaking Medicine Technology:
(Date:10/13/2015)... ... October 13, 2015 , ... Altec ... their Title Sponsorship of Synergy 2015. The annual WennSoft KEY2ACT user conference will ... Ranch and will unite customers, partners, WennSoft team members and sponsors to facilitate ...
(Date:10/13/2015)... ... 13, 2015 , ... Georgia Partnership for TeleHealth ... Georgia, along with affiliate organizations, Alabama Partnership for Telehalth (ATP) and Florida Partnership ... Fall 2015. , Each of the three conferences share this year’s conference ...
(Date:10/13/2015)... ... October 13, 2015 , ... Local Gold’s Gym franchise owner, Bryce Berry, received ... 26. Berry, who owns and operates Gold's Gym Cheyenne in Cheyenne, Wyoming, ... in the United States. A brand leader in global fitness, Gold’s Gyms are located ...
(Date:10/13/2015)... ... October 13, 2015 , ... With Fall weather approaching ... tool for this month’s Facebook Hair Styler Contest. , Enter to win! , How ... Answering: What Is Your Favorite Hair Style? , 3. Follow us on Instagram ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... home furnishings and décor, today announced it closed on a $20.5 million funding ... will be used to support the Company’s continued rapid growth and expansion, broaden ...
Breaking Medicine News(10 mins):