FDA OKs GE HealthCare’s Head-Only Signa Magnus 3T MRI

GE HealthCare has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Signa Magnus 3T, head-only magnetic resonance imaging (MRI) scanner.

Signa Magnus 3T provides new capabilities for clinical imaging and neuroscience. It can potentially aid in detection of neurological, oncological, and psychiatric conditions.

It features an asymmetrical, high-efficiency, head-only gradient coil design, which the company said achieves better gradient performance because of a reduced inner diameter specifically tailored to neuroimaging. The asymmetrical design moves the gradient isocenter to the patient edge of the coil instead of its geometric center, allowing head access and avoiding shoulder width limitations.

GE HealthCare said the head-only design of Magnus allows it to deliver a gradient amplitude and slew rate that exceeds conventional 60 cm or 70 cm bore whole-body MRIs.

“Obtaining FDA clearance further validates our commitment to not only innovating but also in delivering clinical technologies that have real-world impact,” said Jason Polzin, GM, MR Applications Platform and Research Technologies, GE HealthCare. “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.”

A New Standard for Neuroimaging & Biomarker Discovery

Signa Magnus introduces HyperG gradients, which GE HealthCare said are one of the most efficient gradient coils on the market. The HyperG coil’s asymmetric, head-only design invokes far less peripheral nerve stimulation to maximize use of the system’s gradient performance for clinical and research scanning.

HyperG gradient technology achieves performance levels of 300 mT/m and 750 T/m/s, permitting faster image acquisition while utilizing the same power requirement as the whole-body Signa Premier 3T system.

Signa Magnus can visualize brain function, microstructure, and micro-vasculature through ODEN (Oscillating Gradient Diffusion Encoding). ODEN leverages oscillating gradients for cellularity contrast, which can be important for neurological oncology. GE HealthCare said its intention is to use Signa Magnus’ high-gradient performance capabilities to allow high B-value diffusion imaging, fMRI for investigating the BOLD (Blood Oxygen Level Dependent) response and measurement of slow CSF (Cerebral Spinal Fluid) flow.

It will be available for both forward production and upgrades from compatible Signa Premier system, meaning existing facilities can have access to high-performance imaging without needing entirely new systems, additional power, or cooling.

“We’re very excited about the capabilities SIGNA MAGNUS provides,” said Kawin Setsompop, Ph.D., Associate Professor of Radiology and by courtesy Electrical Engineering, Associate Chair of Research Strategic Development, Stanford University. “I plan to leverage the gradient performance to look at microstructures with diffusion imaging, such as axonal diameter. Additionally, using the high slew rate for efficient readout in terms of EPI and spiral to sample k-space faster will help achieve higher resolution with fewer artifacts.”