Siemens garners FDA clearance for Magnetom Terra 7T MRI system

The FDA announced Thursday that it granted 510(k) clearance to Siemens' Magnetom Terra, making it the first seven tesla (7T) magnetic resonance imaging (MRI) system cleared for clinical use in the world. Specifically, the Magnetom Terra is indicated for patients weighing more than 66 pounds, and is limited to examinations of the head and extremities.  

According to the agency, the scanner has more than twice the static magnetic field strength available for use in the US, with Robert Ochs, director of the Division of Radiological Health in the FDA's Center for Devices and Radiological Health, noting "the added field strength allows for better visualisation of smaller structures and subtle pathologies that may improve disease diagnosis." 

The FDA stated that approval was based on comparison to a predicate device and acquisition of sample clinical images. Further, the agency said radiologists who reviewed data from a study, involving 35 healthy participants, that compared images obtained using the 7T and 3T MRI systems, also confirmed that the images obtained with the Magnetom Terra "were of diagnostic quality and, in some cases, an improvement over imaging at the 3T." The FDA added that safety of the device was verified via computational modelling, simulations and experimental validation. 

Christoph Zindel, head of magnetic resonance at Siemens Healthineers, noted that the Magnetom Terra 7T scanner is "the first MRI field strength above 3T to be cleared for clinical imaging in nearly 20 years." He added that the system's ultra-high-field strength may also allow clinicians "to achieve new, unforeseen levels of patient care and clinical advancements through improved visualisation of a wide variety of neurological disease states." 

 

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