FDA clears Siemens Magnetom Terra 7T MRI

The FDA today granted 510(k) clearance to the first seven-tesla magnetic resonance imaging system approved for the U.S market, the Magnetom Terra system made by Siemens Healthineers (NYSE:SI).
“The overall image quality of MRI improves with higher magnetic field strength,” FDA radiological health director Robert Ochs said in prepared remarks. “The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”
The clearance limits use of the device to scans of the head and extremities in patients of more than 66 pounds, the federal safety watchdog said.
“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,” added Siemens Healthineers magnetic resonance head Dr. Christoph Zindel. “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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Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Imaging Regulatory/Compliance Wall Street Beat Siemens Source Type: news