CE Mark for 7 Tesla magnetic resonance (MR) scanner Magnetom Terra.-Siemens Healthineers
Siemens Healthineers has achieved a CE 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. Clinicians in Europe can now use the system for neurological and musculoskeletal examinations in routine clinical applications, as the CE mark means that the product meets all EU requirements with regard to safety, clinical benefit, and environmental protection.
Due to its very high spatial and spectral resolution, 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. At 7T (7 Tesla), lesions can be identified more clearly thanks to the higher resolution and stronger image contrast.
Comment: Magnetom Terra's current FDA approval status is "510(k) pending".