FDA Clears Siemens 7T MRI Device

FDA has cleared a Siemens Medical Solutions 510(k) for the first seven-tesla (7T) magnetic resonance imaging device, Magnetom Terra, which more than doubles the static magnetic field strength available for use in the U.S. “The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis,” an FDA release says.

The agency says it reviewed the safety of the radiofrequency subsystem through computational modeling, simulations and rigorous experimental validation. Siemens also provided data from a comparative study of 35 healthy patients that compared images of the patients using the 7T device and images using its 3T device. “Board-certified radiologists reviewed the images and confirmed that the images acquired on the 7T device were of diagnostic quality and, in some cases, an improvement over imaging at the 3T,” it says.