FDA Gives First Clearance to Siemens High-Field 7 Tesla MRI Scanner


Siemens Healthineers won FDA clearance to introduce its 7 Tesla MRI scanner, the MAGNETOM Terra. The device won European regulatory approval in August, kicking off an age of high-field MRI scanning that produces imaging details previously unavailable in a clinical setting. Previously, only scanners with a field strength of 3 Tesla were the most powerful MRIs cleared by the regulatory agencies for clinical use.

Of note, 7 Tesla and more powerful scanners have been around in research institutions for years now. The MAGNETOM Terra can still be applicable in research, as it includes the ability to quickly switch it from commonly used, and FDA approved, clinical protocols to those used in scientific research. Even the data from the two scanning modes is kept separate on different databases

A more powerful scanner produces more detailed images of the body, particularly useful in brain studies. As an example, the MAGNETOM Terra is able to distinguish between the white and gray matter of the brain, something that can be useful when deciding on treatment options for people with epilepsy. For people with multiple sclerosis, the device can help identify lesions within the gray matter.

Siemens Healthineers touts that this is the lightest actively shielded 7 Tesla MRI machine, and is about as easy to install as a now more standard 3 Tesla scanners.

More details about the device according to Siemens Healthineers:

The scanner delivers superior images with up to 64 receive channels and more than twice the signal-to-noise (SNR) ratio of 3T MRI in optimized 7Tneuro and MSK clinical applications. Its 80/200 gradients provide high levels of power to not only perform diffusion MRI and functional MRI (fMRI), but also to utilize the company’s Simultaneous Multi-Slice (SMS) application to accelerate advanced neurological applications for clinical routine. Its ultrafine 0.2 mm in-plane anatomical resolution potentially enables visualization of previously unseen anatomical structures. For example, cerebral cortex imaging at 0.2mm in-plane resolution may yield never-before-visible clinical details in cortical structure. And the scanner’s submillimeter BOLD fMRI contrast increases linearly with field strength; this could translate, in clinical use, to higher resolution in neuro imaging compared to 3T applications. The scanner has two coils optimized for clinical neuro and knee imaging – the first FDA-cleared applications for 7T MRI. The MAGNETOM Terra leverages the syngo MR E11 software platform from Siemens Healthineers, enabling users to work in the same manner as they would with the company’s 1.5T and 3T technology. The MAGNETOM Terra also features the hyper-fast image reconstruction technology of the MaRS (Measurement and Reconstruction System) computer, for speeds up to 20 times faster than previous generations of 7T research scanners.

Flashback: EU Gives First Approval for Ultra-High-Field MRI Scanner, The Siemens Magnetom Terra…

Product page: MAGNETOM Terra…

Via: Siemens Healthineers…

Source: Medgadget


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