Just weeks after receiving CE (Conformité Européenne) approval for commercial sale in Europe, Siemens Healthineers’ Magnetom Terra 7-Tesla magnetic resonance scanner also received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The FDA has approved use of the scanner to image the head and knees. The first clinical customer in North America will be the Mayo Clinic in Rochester, MN. The scanner is planned to be operational at Mayo Clinic by the end of this year.
The Magnetom Terra, described here in an Applied Radiology news brief, provides more than twice the magnetic field strength of a conventional 3-Tesla scanner to deliver ultra-fine image resolution of the head and extremities. Its use is intended for patients weighing more than 66 pounds.
In a press release, Mayo Clinic stated that its radiologists anticipate using the scanner for sophisticated neurological and musculoskeletal imaging. Kent Thielen, MD, chair of the Department of Radiology, said that applications are planned to achieve higher-resolution imaging of the brain to visualize small lesions in patients who present with trauma-related micro=hemorrhages or multiple sclerosis lesions that might not be detected at lower field strength. He and his colleagues also anticipate being able to visualize the anatomic source of seizures in previously undiagnosed patients, and to improve anatomic detail and support a higher degree of confidence in noninvasive diagnosis when imaging cartilage and other tissues of the knee.
Siemens 7T MR scanner clears FDA; 1st clinical system heads to Mayo Clinic. Appl Radiol.