FDA Clears MAGNETOM Terra 7T MRI Scanner From Siemens Healthineers

The U.S. Food and Drug Administration (FDA) has cleared the MAGNETOM Terra magnetic resonance imaging (MRI) scanner from Siemens Healthineers, the first-ever 7 Tesla (7T) MRI cleared for diagnostic imaging. This advanced ultra-high-field scanner produces cross-sectional images of the head and knee, and is intended for patients over 66 lbs. The system’s neurological and musculoskeletal (MSK) applications have the potential to help physicians achieve unprecedented breakthroughs in clinical care by revealing functional and anatomical details not visible at lower magnet field strengths.
 
Building upon the company’s history as a provider of 7T MRI to the global research community, the new MAGNETOM Terra possesses the Dual Mode feature, which permits the user to switch for the first time ever between an investigational “Research Mode” and a 510(k)-cleared “Clinical Mode” for imaging, while keeping research data and clinical images safe on separate databases, respectively. The scanner delivers images with up to 64 receive channels and more than twice the signal-to-noise (SNR) ratio of 3T MRI in optimized 7Tneuro and MSK clinical applications. Its 80/200 gradients provide high levels of power to not only perform diffusion MRI and functional MRI (fMRI), but also to utilize the company’s Simultaneous Multi-Slice (SMS) application to accelerate advanced neurological applications for clinical routine. Its ultrafine 0.2 mm in-plane anatomical resolution potentially enables visualization of previously unseen anatomical structures. For example, cerebral cortex imaging at 0.2mm in-plane resolution may yield never-before-visible clinical details in cortical structure. And the scanner’s submillimeter BOLD fMRI contrast increases linearly with field strength; this could translate, in clinical use, to higher resolution in neuro imaging compared to 3T applications. The scanner has two coils optimized for clinical neuro and knee imaging—the first FDA-cleared applications for 7T MRI. The MAGNETOM Terra leverages the syngo MR E11 software platform from Siemens Healthineers, enabling users to work in the same manner as they would with the company’s 1.5T and 3T technology. The MAGNETOM Terra also features the hyper-fast image reconstruction technology of the MaRS (Measurement and Reconstruction System) computer, for speeds up to 20 times faster than previous generations of 7T research scanners.
 
Possessing these and other unique features and capabilities, the MAGNETOM Terra can be leveraged by healthcare institutions to grow their professional and academic reputations, attract and retain premier talent, secure highly coveted research grants, and maintain their competitive edge.
 
“With the MAGNETOM Terra 7T scanner, Siemens Healthineers proudly introduces the first MRI field strength above 3T to be cleared for clinical imaging in nearly 20 years,” said Christoph Zindel, M.D., senior vice president and head of Magnetic Resonance at Siemens Healthineers. “Armed with the MAGNETOM Terra’s ultra-high-field strength, clinicians may be able to achieve new, unforeseen levels of patient care and clinical advancements through improved visualization of a wide variety of neurological disease states.”
 
The MAGNETOM Terra is constructed from top to bottom by Siemens Healthineers—the first time every major component of a 7T scanner has been manufactured entirely by one equipment vendor. Addressing concerns regarding helium availability, the MAGNETOM Terra has a Zero Helium boil-off feature that reduces evaporation in both standby and operational modes. And the scanner’s new magnet, which is 50 percent lighter than any 7T magnet produced to date, can be shipped cold via airfreight and integrated more easily into clinical environments, even on upper floors.
 
Siemens Healthineers is the separately managed healthcare business of Siemens AG, enabling healthcare providers worldwide to meet their current challenges and to excel in their respective environments. Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. In fiscal 2016, which ended on Sept. 30, 2016, Siemens Healthineers generated revenue of 13.5 billion euros and profit of over 2.3 billion euros. The company employs about 46,000 workers worldwide.