FDA approves Magnetom Terra for MRI imaging.- Siemens.

The FDA has cleared the Magnetom Terra, the first seven tesla (7T) magnetic resonance imaging (MRI) device, from Siemens, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in the United States.

The FDA reviewed the Magnetom Terra through the 510(k) premarket clearance pathway. The FDA based its clearance on comparison to a predicate device and acquisition of sample clinical images. The agency reviewed the safety of the radiofrequency subsystem through computational modeling, simulations and rigorous experimental validation. The manufacturer also provided data from a comparative study of 35 healthy patients that compared images of the patients using the 7T device and images using the 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. The Magnetom Terra is for patients who weigh more than 66 pounds, and is limited to examinations of the head, arms and legs (extremities).