Siemens Medical Solutions has obtained 510(k) premarket clearance from the US Food and Drug Administration (FDA) for its Magnetom Terra seven tesla (7T) magnetic resonance imaging (MRI) system.
Magnetom Terra, which is indicated for examinations of the head, arms and legs in patients who weigh greater than 66lb, features more than double the static magnetic field strength (3T) being currently used in the country.
The new device is designed to provide high-quality images with ultra-high-field technology, as well as improved workflow and patient experience.
FDA Centre for Devices and Radiological Health’s Radiological Health division director said: “The overall image quality of MRI improves with higher magnetic field strength.
“The added field strength allows for better visualisation of smaller structures and subtle pathologies that may improve disease diagnosis.”
The FDA clearance is based on a comparison of the new MRI system with a standard device and analysis of sample clinical images acquired using the system.
Computational modelling, simulations and rigorous experimental validation were used to review the safety of the radiofrequency subsystem.
The agency also analysed results provided by the firm from a study conducted in 35 healthy individuals comparing images obtained with the 7T system and those acquired through a 3T device.
Following review by board-certified radiologists, it was observed that the images obtained using Magnetom Terra were of diagnostic quality and showed an improvement in certain cases when compared to the 3T.