The US Food and Drug Administration (FDA) today approved the first seven tesla (7T) MRI system, which offers sharper visualization and diagnoses because it has more than double the static magnetic field strength of other devices on the market.
The souped-up MRI system, made by Siemens Medical Solutions, is called Magnetom Terra. The FDA is limiting its use to imaging the head, arms, and legs of patients who weigh more than 66 pounds.
Tesla is a unit measure of magnetic field strength. Before the Magnetom Terra system, MRI systems on the market had not topped 3T.
“The overall image quality of MRI improves with higher magnetic field strength,” said Robert Ochs, PhD, director of the Division of Radiological Health in the FDA’s Center for Devices and Radiological Health, in a news release. “The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”
Using its 510(k) review process, the FDA determined that the Magnetom Terra system is substantially the same as other MRI systems on the market. The agency performed computational modeling, simulations, and experiments to assess the safety of the new MRI system. It also reviewed a study by Siemens Medical Solutions that compared images of healthy patients taken with its 7T system with those taken with a 3T system. “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 agency said.
More information on today’s announcement is available on the FDA website.
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