On October 12, the U.S. Food and Drug Administration (FDA) cleared the first 7-Tesla (7T) magnetic resonance imaging (MRI) device, 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 overall image quality of MRI improves with higher magnetic field strength,” stated Robert Ochs, PhD, Director of the Division of Radiological Health in the 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.”
MRI scanners come in different magnet field strengths measured in teslas. Before this clearance by the FDA, clinical MRI systems were available in field strengths of 3T and below.
The FDA reviewed the Magnetom Terra through the 510(k) premarket clearance pathway, ie, with submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. 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 (Siemens Medical Solutions Inc) 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 lb and is limited to examinations of the head and extremities.
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