日前，美国食品药品管理局（FDA）批准了世界上第一台，由西门子公司出品的，可同步完成磁共振成像（MRI）和正电子发射计算机断层显像（PET）检查的装置供临床试用。这无疑是一个好消息和一大突破，因为该系统的问世：一可节省医院有限的空间，因它将以往两个成像装置整合为一个装置，故其占地面积显然减少了一半；二是可以节省患者和医生的时间，其原因同样是因为可以同步完成二项检查，而无需像以往那样要分别完成MRI和PET检查，和搬运患者等；三是有可能节省医院添置设备的费用；四是因操作该系统和解读该系统产生的结果需要放射科和核医学科的专家共同努力，故该装置的问世有可能产生一个临床科室或学科。更多资讯，请参阅原文：

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.