GE HealthCare's SIGNA MAGNUS Head-Only MRI System Receives FDA Clearance

GE HealthCareView company profile has secured FDA 510(k) clearance for its SIGNA MAGNUS (search)Search drug, a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner designed to advance neuroimaging and biomarker research. This system offers new capabilities for clinical imaging and neuroscience, potentially aiding in the detection of neurological (search)Search disease, oncological (search)Search disease, and psychiatric conditions.

Advancing Neuroimaging with Innovative Design

The SIGNA MAGNUS (search)Search drug features an innovative asymmetrical, high-efficiency, head-only gradient coil design, tailored specifically for neuroimaging. The asymmetrical design shifts the gradient isocenter to the patient edge of the coil, facilitating patient head access and avoiding shoulder width constraints. This head-only design allows MAGNUS to deliver a gradient amplitude and slew rate surpassing those of conventional whole-body MRI systems.

"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 HealthCareView company profile. "With SIGNA MAGNUS (search)Search drug, we are providing neuroradiologists and neuroscience researchers a tool that supports advanced imaging and biomarker research and discovery previously impossible on conventional systems."

A New Standard for Biomarker Discovery

The SIGNA MAGNUS (search)Search drug offers exceptional precision, enabling high-resolution, high signal-to-noise ratio imaging, advanced diffusion techniques, and short scan times. Four investigational MAGNUS systems have already been installed at leading medical centers, including Walter Reed National Military Medical Center and Brigham and Women’s Hospital.

Dr. Vince A. Magnotta, PhD, Director of the MR Research Facility and Professor of Radiology at the University of Iowa, emphasized the importance of the FDA clearance, stating, "FDA clearance is important because there’s a broad need for new biomarkers to study neurodegenerative disorders (search)Search disease, and there’s an opportunity to better understand what’s happening in psychiatric disorders (search)Search disease."

Enhanced Gradient Technology

GE HealthCareView company profile has incorporated HyperG gradients into the SIGNA MAGNUS (search)Search drug system. The innovative asymmetric head-only design of the HyperG gradient coil invokes significantly less Peripheral Nerve Stimulation (PNS), maximizing the system’s gradient performance for both clinical and research scanning. The HyperG gradient technology achieves performance levels of 300 mT/m and 750 T/m/s, enabling faster image acquisition while using the same power requirement as the whole-body SIGNA Premier 3.0T system. Shorter scan times are particularly beneficial for patients who may have difficulty remaining still or those with claustrophobia. Improved gradient strengths lead to enhanced spatial resolution and image clarity, potentially resulting in more accurate diagnoses.

Clinical and Research Applications

The enhanced capabilities of the SIGNA MAGNUS (search)Search drug system provide ultra-high anatomical resolution with shorter scan times. It allows for visualization of brain function, microstructure, and micro-vasculature through innovations such as ODEN (Oscillating Gradient Diffusion Encoding). The high-gradient performance of SIGNA MAGNUS facilitates advanced research scanning, such as high B-value diffusion imaging and fMRI for investigating the BOLD (Blood Oxygen Level Dependent) response.

Kawin Setsompop, PhD, Associate Professor of Radiology at Stanford University, stated, "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."

The SIGNA MAGNUS (search)Search drug will be available for both forward production and upgrades from compatible SIGNA Premier systems, expanding access to high-performance imaging without the need for entirely new systems. This FDA clearance empowers the clinical community to adopt SIGNA MAGNUS into routine practice and further advances research in critical areas such as neurodegenerative, neuro-oncology (search)Search disease and psychiatric disorders (search)Search disease.