According to the U.S. Food and Drug Administration last Friday, Siemens AG's device that simultaneously performs two common diagnostic tests received clearance from them. The German engineering company's U.S.-based Siemens Medical Solutions, which is based in Pennsylvania, manufactures the device.
The device is called BioGraph mMR and it simultaneously performs a positron emission tomography scan, commonly known as PET scan, and a magnetic resonance imaging, or MRI, scan. The FDA on Friday said the BioGraph is the first device to do both these scans at once. The device's advantages over current systems include;
- simultaneous imaging,
- reduced radiation dose and,
- increased soft-tissue contrast.
PET scans involve injection of a radioactive tracer into the bloodstream, which gives doctors a glimpse of internal organs and tissue. MRI uses a magnetic field and radio waves to create detailed images of the body's organs, soft tissue and bones.
The new device uses MRI technology rather than computer tomography scanning to produce detailed images of the inner structure of the body. The device was cleared based on bench tests comparing the BioGraph with an earlier PET/CT device, the FDA said. As with stand-alone MRIs, people with pacemakers, defibrillators and other implanted electronic devices should avoid the new system, since the scanner's strong magnetic fields could interfere with those devices, the agency added.
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