FDA www.fda.gov has granted clearance of the Magnetom Terra scanner to Siemens Healthineers https://usa.healthcare.siemans.com, the separately managed healthcare business of Siemens AG. MRI scanners come in different magnet field strengths measured in tesla or “T”.
The scanner is the first seven tesla (7T) Magnetic Resonance Imaging (MRI) device cleared for diagnostic imaging in the U.S and more than doubles the static magnetic field strength currently available. Before FDA’s clearance of the 7T, clinical MRI systems were only available in field strengths of 3T and below.
“The overall image quality of the 7T MRI improves with higher magnetic field strength,” reports Robert Ochs PhD, Director of the Division of Radiological Health in FDA’s Center for Devices and Radiological Health. “The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”
FDA reviewed the safety of the radio frequency subsystem through computational modeling, simulations, and experimental validation. The manufacturer also provided data from a comparative study of 35 healthy patients,
The patient’s images were compared using the 7T device with 3T devices. Board certified radiologists reviewed the images and confirmed that the images acquired on the 7T device were of diagnostic quality.