GE HealthCare has announced the US Food and Drug Administration (FDA) 510(k) clearance for its Signa Magnus magnetic resonance imaging (MRI) scanner.
The 3-tesla (T) head-only scanner is designed to improve clinical imaging and neuroscience research, assisting in the detection of various oncological, neurological, and psychiatric conditions. Signa Magnus features a high-efficiency asymmetrical, gradient coil design. This design helps in achieving higher gradient performance with a reduced inner diameter, making it ideal for neuroimaging applications, a recent press release describes.
It also allows for better patient head access by shifting the gradient isocentre towards the edge of the coil. This eliminates shoulder width constraints and enables a gradient amplitude and slew rate that surpasses conventional whole-body MRI systems.
Signa Magnus’ precision enables advanced imaging methods, offering high-resolution and signal-to-noise ratio with brief scan times. Short scan times and improved gradient strengths contribute to enhanced spatial resolution and image clarity, which can lead to more accurate diagnoses.
The system’s HyperG gradient technology has performance levels of 300mT/m and 750T/m/s, allowing for faster image acquisition without increased power requirements.
Signa Magnus’ capabilities in visualising brain function, microstructure, and micro-vasculature are further improvised by oscillating gradient diffusion encoding technology which delivers cellularity contrast.
The system will be available for new installations and as an upgrade from compatible Signa premier systems, allowing existing facilities to adopt this advanced technology without significant infrastructure changes.
Four investigational Signa Magnus scanners are currently installed at institutions, including Walter Reed National Military Medical Center and the University of Iowa, among others in the USA.
GE HealthCare MRI applications platform and research technologies general manager Jason Polzin said: “Obtaining FDA clearance further validates our commitment to not only innovating but also delivering clinical technologies that have real-world impact.
With Signa Magnus, we are providing neuroradiologists and neuroscience researchers a tool that supports advanced imaging and biomarker research and discovery previously impossible on conventional systems. It is our intent to make Signa Magnus widely available as a fully cleared commercial product.”
