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CE Marking Tamilnadu

EU grants 1st approval for Siemens’ new MRI scanner

Siemens Healthcare Korea said Thursday that Siemens Healthineers won the first European regulatory approval for an ultra-high field magnetic resonance imaging (MRI) scanner called Magnetom Terra.

European medical practitioners will be able to use Magnetom Terra in routine clinical settings for neurological and musculoskeletal examinations with the CE certification.

The EU regulatory body’s stamp of approval specifies the device meets all necessities regarding stability, clinical benefit and environmental protection in radiology, the company said.

“Magnetom Terra’s CE certification is the first of its kind in 15 years since the 3-Tesla MR devices,” said Christoph Zindel, senior vice-president and general manager of Siemens Healthineers MRI division. “We are confident that Magnetom Terra will support open up new horizons in MRI medical research and clinical practice.”

The scanner is an ultra-high field MR system with a magnetic field strength of 7-Tesla, which is extraordinarily stronger than the current high-end standard 3-Tesla. The scanner was used mainly by researchers to see the brain in minute detail, recognizing components in the brain as small as a grain of sand.

Magnetom Terra’s brilliant spatial and spectral resolution will help medical practitioners examine the human musculoskeletal system in detail and precisely photograph brain metabolism procedure, the company said.

The device can also visually confirm neurological diseases like Alzheimer’s, brain metastasis, and multiple sclerosis, it said. In particular, it can recognize lesions more clearly such as better white and gray matter differentiation in epilepsy and improved visibility in gray matter for multiple sclerosis.

“We have been able to realize 7-Tesla MR imaging in a clinical setting as a result of many years of collaborative research in the field of ultrasound MRIs with a broad network of research collaboration partners around the world,” Zindel added.

The device is pending on U.S. FDA approval and is in the pre-approval stage in Korea.


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