The FDA has cleared the Magnetom Terra MRI scanner from Siemens Healthineers—the first-ever 7 Tesla (7T) MRI cleared for diagnostic imaging. This ultra-high-field scanner produces cross-sectional images of the head and knee, and is intended for patients over 66 pounds. Further, the system’s neurological and musculoskeletal (MSK) applications enable physicians to see functional and anatomical details not visible at lower magnet field strengths.

The Magnetom Terra offers the Dual Mode feature, which permits the user to switch for the first time ever between an investigational “Research Mode” and a 510(k)-cleared “Clinical Mode” for imaging, while keeping research data and clinical images safe on separate databases, respectively. The scanner delivers images with up to 64 receive channels and more than twice the signal-to-noise ratio of 3T MRI in optimized 7Tneuro and MSK clinical applications.

What’s more, 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 application to accelerate advanced neurological applications for clinical routine. And its 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.

“With the Magnetom Terra 7T scanner, Siemens Healthineers proudly introduces the first MRI field strength above 3T to be cleared for clinical imaging in nearly 20 years,” says Christoph Zindel, MD, senior vice president and head of magnetic resonance Mat Siemens Healthineers. “Armed with the Magnetom Terra’s ultra-high-field strength, clinicians may be able to achieve new, unforeseen levels of patient care and clinical advancements through improved visualization of a wide variety of neurological disease states.”

Robert Ochs, PhD, director of the Division of Radiological Health in the FDA’s Center for Devices and Radiological Health, also spoke out about the product clearance, commenting: “The overall image quality of MRI improves with higher magnetic field strength. The added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”