The U.S. Food and Drug Administration (FDA) cleared the first 7 Tesla MRI device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra from Siemens Healthineers is the first 7T MRI system cleared for clinical use in the United States. MRI scanners use strong magnetic fields and radio waves (radiofrequency energy) to generate images. The signal comes mainly from the protons in fat and water molecules in the body.
The FDA reviewed the Magnetom Terra (Siemens) through the 510(k) premarket clearance pathway. The FDA based its clearance on comparison to a predicate device and acquisition of sample clinical images. The agency reviewed the safety of the radiofrequency subsystem through computational modeling, simulations and rigorous experimental validation. The manufacturer also provided data from a comparative study of 35 healthy…
