GE HealthCare Receives FDA 510(k) Clearance for SIGNA™ MAGNUS, a High-Performance 3.0T Head-Only MRI System

GE HealthCare (Nasdaq: GEHC)'s innovative SIGNA™ MAGNUS has received FDA 510(k) clearance, a 3.0T high-performance head-only magnetic resonance imaging (MRI) scanner. The system offers new capabilities for clinical imaging and neuroscience, with the potential to assist in detecting neurological, oncological, and psychiatric disorders.

SIGNA MAGNUS Receives FDA Approval, Highlighting GE Healthcare's Advancements in Neuroimaging. It features an innovative asymmetric, high-efficiency, head-dedicated gradient coil design that achieves higher gradient performance due to the reduced inner diameter, specifically tailored for neuroimaging. The asymmetric design shifts the gradient isocenter to the patient edge of the coil rather than its geometric center, enabling head access without shoulder width limitations. This head-dedicated design allows MAGNUS to deliver gradient amplitude and slew rates far exceeding those of traditional 60 cm or 70 cm inner diameter whole-body MRI systems, marking a significant advancement in MRI technology for neuroimaging applications.

GE Healthcare MR Application Platform and Research Technology General Manager Jason Polzin stated: "Receiving FDA approval further validates our commitment not only to innovation but also to delivering clinical technologies with real-world impact. With SIGNA MAGNUS, we are providing neuro-radiologists and neuroscience researchers with a tool that supports advanced imaging and biomarker research and discovery, which were previously impossible on conventional systems. Our goal is to make SIGNA MAGNUS widely available as a fully approved commercial product."

New Standards in Neuroimaging and Biomarker Discovery

SIGNA MAGNUS delivers exceptional precision, enabling high-resolution, high signal-to-noise ratio imaging, advanced diffusion techniques, and shorter scan times. To date, four research MAGNUS systems have been installed at Walter Reed National Military Medical Center, the University of Iowa, the University of Wisconsin-Madison, and Brigham and Women’s Hospital.

Vince A. Magnotta, PhD, Professor of Radiology in the Department of Neuroradiology and Director of the MR Research Facility at the University of Iowa, expressed appreciation for the FDA approval, stating, "The FDA approval is significant because new biomarkers are needed to study neurodegenerative diseases, and there is an opportunity to better understand the progression of psychiatric disorders."

GE Healthcare Demonstrates Its Leadership in High-Performance Gradient Technology by Introducing the HyperG Gradient Coil in the SIGNA MAGNUS System, One of the Most Efficient Gradient Coils on the Market[ii]. The HyperG Gradient Coil Features an Innovative Asymmetrical Head-Only Design, Significantly Reducing Peripheral Nerve Stimulation (PNS) and Maximizing the Practical Utilization of System Gradient Performance in Clinical and Research Scans.

HyperG Gradient Technology Achieves Excellent Performance Levels of 300 mT/m and 750 T/m/s, Acquiring Images Faster While Using the Same Power Requirements as the Whole-Body SIGNA Premier 3.0T System. Shorter Scan Times Mean Less Time Spent on the MRI Machine, Which Is Particularly Beneficial for Patients Who Have Difficulty Remaining Still or Suffer from Claustrophobia. The Increase in Gradient Strength Enhances Spatial Resolution and Image Clarity, Enabling Accurate Diagnoses That Allow Healthcare Providers to Detect Subtle Abnormalities and Offer Better Treatment Options.

Clinical and Research Excellence

The enhanced capabilities of the SIGNA MAGNUS system provide ultra-high anatomical resolution in shorter scan times. It enables the visualization of brain function, microstructure, and microvasculature through innovative techniques such as ODEN (Oscillating Gradient Diffusion Encoding), which uses oscillating gradients to deliver cellular contrast—an important feature for neuro-oncology. Our aim is to leverage the high gradient performance of SIGNA MAGNUS for advanced research scans, including high b-value diffusion imaging, fMRI for studying BOLD (Blood-Oxygen-Level-Dependent) responses, and measurements of slow CSF (Cerebrospinal Fluid) flow. This marks a transformative step forward in neuroscience research.

Kawin Setsompop, PhD, Associate Professor of Radiology at Stanford University and Deputy Director of Research Strategy Development in the Department of Electrical Engineering, stated, "We are very excited about the capabilities offered by SIGNA MAGNUS. I plan to utilize gradient performance to examine microstructures through diffusion imaging, such as axon diameter. Additionally, employing high slew rate efficient readouts like EPI and spiral to sample k-space more rapidly will help achieve higher resolution and fewer artifacts."

SIGNA MAGNUS can be used for both forward production and upgrading from compatible SIGNA Premier systems. This means existing facilities can upgrade to this advanced technology, expanding the reach of high-performance imaging without requiring an entirely new system, additional power, or cooling. FDA approval enables the clinical community to apply SIGNA MAGNUS in daily practice and further advance research in critical areas such as neurodegenerative diseases, neuro-oncology, and psychiatric disorders.

For more information about SIGNA MAGNUS, please visit the Radiological Society of North America (RSNA) annual meeting held in Chicago from December 1 to December 4, 2024, or visit gehealthcare.com online.

About GE HealthCare Technologies, Inc.

GE Healthcare is a global leader in medical technology, pharmaceutical diagnostics, and digital solutions innovation. It is committed to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, treatments more precise, and patients healthier and happier. With over 125 years of history in serving patients and healthcare providers, GE Healthcare is advancing personalized, connected, and compassionate care while simplifying the patient journey across the entire care pathway. Our imaging, advanced visualization solutions, patient care solutions, and pharmaceutical diagnostics businesses collectively help improve patient care from diagnosis to treatment and monitoring. As a $19.6 billion enterprise with approximately 51,000 colleagues, we are dedicated to creating a world where healthcare knows no limits.

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