Siemens obtains first CE approval for ultra-high-field 7T MR scanner
Siemens Healthineers has received a CE (Conformité Européenne) approval for the 7 Tesla magnetic resonance (MR) scanner Magnetom Terra, making it the first-ever ultra-high-field MR scanner to be approved for clinical use. The system, which provides greater detail for neurological and musculoskeletal precision is now commercially available in Europe.
The Magnetom Terra provides detailed insights into the human musculoskeletal system, presents a precise picture of the metabolic processes in the brain, and also aids in the visualization of neurological diseases such as Alzheimer’s, epilepsy, and multiple sclerosis (MS). The advantages of ultra-high-field imaging are especially apparent in brain imaging, according to the company. At 7T, lesions can be identified more clearly with its higher resolution and stronger image contrast.
With Magnetom Terra’s Dual Mode functionality, users can easily switch between the clinical protocols and innovative research methods, making the system it an optimal platform for translational research, and allowing the use of 7T to be expanded, such as for whole-body applications. Until now, 7T has typically been used to examine and enhance the visibility of extremely small pathologies with anatomical imaging, as well as sub-cortical brain activations utilizing functional imaging. Siemens anticipates that the exploration of metabolic changes in the patient will play an important role in future research.
Siemens states that the actively shielded magnet on the Magnetom Terra system is the lightest 7 Tesla whole-body magnet in the world, being 50 percent lighter than previous actively shielded magnets. The low total weight of Magnetom Terra facilitates its installation in the clinical environment. Magnetom Terra uses the same software platform as other clinical scanners from Siemens Healthineers in the 1.5T and 3T segments and is closely modeled on their established user interface. In conjunction with specially optimized applications for the 7 Tesla system, this allows easy operation of the ultra-high-field system in clinical routine, as well as the easy exchange of study protocols across other MR systems.
The Magnetom Terra’s current status for 510(k) clearance is pending with the U.S. Food and Drug Administration.