FDA Clears First Seven Tesla MRI Device
The highest field strength available previous to Magnetom Terra clearance was 3T
The Food and Drug Administration announced that they have cleared a seven tesla (7T) magnetic resonance imaging device. The Magnetom Terra (Siemens Healthineers) has more than twice the signal-to-noise ratio of 3T MRI for higher resolution and faster acquisition times.
The device is the first 7T MRI system to be cleared for use in the U.S. The FDA reviewed a 510(k) premarket submission for the device by Siemens and based its clearance on comparison to a predicate device and sample clinical images.
A comparative study of 35 patients was also conducted by the manufacturer. Images using 7T and 3T were taken of these participants and compared, radiologists then reviewed the images and concluded they were of diagnostic quality.
“The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis,” said Robert Oches, PhD, director of the Division of Radiological Health in the FDA's Center for Devices and Radiological Health.
The Magnetom Terra is only for patients who weigh ≥66 pounds and only intended for examination of the head, arms and legs.
For more information visit Siemens.com.