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FDA clears first 7T MRI device
The FDA has cleared the first 7 Tesla MRI machine for use in the United States, a decision that more than doubles the static magnetic field strength available for clinical use, according to a press release.
The Magnetom Terra from Siemens Healthineers is intended for patients who weigh more than 66 pounds and is limited to examinations of the head, arms and legs. According to the company, the system’s neurological and musculoskeletal applications have the potential to help physicians by revealing functional and anatomical details not visible at lower magnet field strengths.
“The overall image quality of MRI improves with higher magnetic field strength,” Robert Ochs, PhD, director of the division of radiological health at the Center for Devices and Radiological Health of the FDA, said in the release. “The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”
According to an FDA release, the agency reviewed the Magnetom Terra through the 510(k) premarket clearance pathway. Prior to the announcement, clinical MRI systems were only available in field strengths of 3T and below.
According to Siemens, the Magnetom Terra includes a unique, dual mode feature, which allows the user to switch between an investigational research mode and a 510(k)-cleared clinical mode for imaging, while keeping research data and clinical images safe on separate databases, respectively. In addition, the scanner produces superior images with up to 64 receive channels and more than twice the signal-to-noise ratio of 3T in optimized clinical applications.
Prior to clearance, the FDA reviewed the safety of the radiofrequency subsystem through computational modeling, simulations and rigorous experimental validation, the FDA release noted. In addition, the manufacturer 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 also 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 with the 3T device, the release noted.
“With the Magnetom Terra 7T scanner, Siemens Healthineers proudly introduces the first MRI field strength above 3T to be cleared for clinical imaging in nearly 20 years,” Christoph Zindel, MD, senior vice president and head of magnetic resonance at Siemens Healthineers, said in the release. “Armed with the Magnetom Terra’s ultra-high-field strength, clinicians may be able to achieve new, unforeseen levels of patient care and clinical advancements through improved visualization of a wide variety of neurological disease states.”
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