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First 7T MRI Approved by the FDA

A couple of weeks ago, the very first 7 tesla strength MRI has been approved by the FDA. The Siemens Magnetom Terra is more than twice the strength of static magnetic field strength available in the U.S.

 

“The overall image quality of MRI improved with higher magnetic field strength,” says Robert Ochs, Ph.D., director of the Division of Radiological Health in the FDA’s Center for Devices and Radiological Health. “The added field strength allows for better visualization for smaller structures and subtle pathologies that may improve disease diagnosis.”

 

The 501(k) clearance the Terra received was based on data acquired by Siemens that compared an older 3T model with the 7T Terra. The 501(k) demonstrates to the FDA that the new device under consideration is substantially equivalent to a legally marketed predicate device.

 

The 3T MRI is an already powerful player in the medical industry. It’s twice as powerful as the previous industry standard, the 1.5T, and is able to better identify a range of conditions including brain and spinal, musculoskeletal, prostate, female pelvic; certain ear, nose, and throat problems; and vascular conditions. It all depends on the patients and their needs, of course, and the radiologist responsible will be able to determine the tesla strength needed.

 

Included in the data sent by Siemens to the FDA was a study of 35 healthy patients comparing images using the 7T and images using the 3T. Reviewing the images were board certified radiologists, who determined that the images acquired on the 7T Terra were of diagnostic quality. They were even an improvement over 3T machines in some cases.

 

The Magnetom Terra is for patients who weigh more than 66 pounds, and is limited to the extremities (the head, arms, and legs.)

 

The FDA is responsible for protecting the safety of U.S. citizens by confirming the effectiveness and security of drugs, vaccines, medical devices, and other biological products meant for human use, as well as our food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulation tobacco products.

 

With the addition of the Magnetom Terra 7T to the playing field, being twice the strength as a 3T, the possibilities are endless. However, it waits to be seen the demand, benefits, and diagnoses garnered from patients in a clinical setting.

 

 

 

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