GE HealthCare Receives FDA Clearance for Head-Only SIGNA MAGNUS 3.0T MRI System
GE HealthCare has received FDA 510(k) clearance for its SIGNA™ MAGNUS, a 3.0T head-only MRI scanner designed for advanced neuroimaging. The system features an innovative asymmetrical head-only gradient coil design that achieves higher gradient performance with reduced inner diameter. The technology delivers gradient amplitude and slew rate superior to conventional whole-body MRI systems, with performance levels of 300 mT/m and 750 T/m/s. The system enables shorter scan times and enhanced spatial resolution while maintaining the same power requirements as the SIGNA Premier 3.0T system. Four investigational MAGNUS systems have already been installed at major medical centers.
GE HealthCare ha ricevuto l'
GE HealthCare ha recibido la para su SIGNA™ MAGNUS, un escáner MRI de 3,0T diseñado exclusivamente para la cabeza, orientado a la neuroimagen avanzada. El sistema cuenta con un innovador diseño de bobina de gradiente asimétrica que logra un rendimiento de gradiente más alto con un diámetro interno reducido. La tecnología proporciona una amplitud de gradiente y una tasa de cambio superiores a los sistemas MRI convencionales de cuerpo completo, alcanzando niveles de rendimiento de 300 mT/m y 750 T/m/s. El sistema permite tiempos de escaneo más cortos y una resolución espacial mejorada, manteniendo los mismos requisitos de energía que el sistema SIGNA Premier 3.0T. Cuatro sistemas MAGNUS en fase de investigación ya han sido instalados en importantes centros médicos.
GE HealthCare는 FDA 510(k) 승인을 받아 전용 머리 MRI 스캐너인 SIGNA™ MAGNUS를 출시했습니다. 이 3.0T 스캐너는 고급 신경 이미징을 위해 설계되었습니다. 이 시스템은 더 작은 내부 직경으로 높은 기울기 성능을 달성하는 혁신적인 비대칭 머리 전용 기울기 코일 디자인을 특징으로 합니다. 이 기술은 전통적인 전신 MRI 시스템보다 우수한 기울기 진폭과 슬루 속도를 제공하며, 성능 수준은 300 mT/m 및 750 T/m/s입니다. 이 시스템은 SIGNA Premier 3.0T 시스템과 동일한 전력 요구 사항을 유지하면서 짧은 스캔 시간과 향상된 공간 해상도를 가능하게 합니다. 현재 4개의 연구용 MAGNUS 시스템이 주요 의료 센터에 설치되어 있습니다.
GE HealthCare a reçu l'
GE HealthCare hat die FDA 510(k) Genehmigung für sein SIGNA™ MAGNUS, einen 3,0T-Kopf-MRI-Scanner, der für die fortschrittliche neurobildgebende Diagnostik konzipiert ist, erhalten. Das System verfügt über ein innovatives asymmetrisches Kopf-Gradienten-Spulendesign, das eine höhere Gradienteneffizienz bei reduziertem Innendurchmesser erreicht. Die Technologie bietet eine Gradientamplitude und Slew-Rate, die herkömmlichen Ganzkörper-MRI-Systemen überlegen ist, mit Leistungswerten von 300 mT/m und 750 T/m/s. Das System ermöglicht kürzere Scan-Zeiten und eine verbesserte räumliche Auflösung bei gleichbleibenden Energieanforderungen wie beim SIGNA Premier 3.0T-System. Vier erprobte MAGNUS-Systeme sind bereits in großen medizinischen Zentren installiert.
- FDA 510(k) clearance received for SIGNA MAGNUS, enabling commercial availability
- Superior technical specifications with 300 mT/m and 750 T/m/s performance levels
- System operates with same power requirements as existing SIGNA Premier 3.0T
- Capability to upgrade from compatible SIGNA Premier systems, reducing implementation costs
- to head-only imaging, restricting full-body scanning capabilities
Insights
The FDA clearance of SIGNA MAGNUS represents a significant technological advancement in neuroimaging. The system's 300 mT/m gradient amplitude and 750 T/m/s slew rate substantially outperform conventional MRI systems, enabling faster scan times and higher resolution imaging. This positions GE HealthCare advantageously in the high-end neuroimaging market.
The head-only design with HyperG gradients offers compelling operational benefits: reduced power requirements, shorter scan times and improved patient comfort. The ability to upgrade existing SIGNA Premier systems makes this technology more accessible to healthcare facilities, potentially driving faster market adoption and revenue growth.
The system's advanced capabilities in detecting neurological, oncological and psychiatric conditions expand GE HealthCare's addressable market in both clinical and research settings. Early adoption by prestigious institutions like Walter Reed and Stanford validates the technology's potential impact on healthcare outcomes and research applications.
This FDA clearance strengthens GE HealthCare's competitive position in the
The technology's focus on neurodegenerative and psychiatric disorders aligns with growing market demands, particularly given the aging population and increased focus on mental health. The reduced operational costs through power efficiency and faster scan times will appeal to healthcare providers seeking to optimize their imaging economics while improving patient care.
- New MRI technology aims to advance neuroimaging and biomarker research
The FDA clearance of SIGNA MAGNUS underscores the advances made by GE HealthCare in neuroimaging. It features an innovative asymmetrical, high-efficiency, head-only gradient coil design, which achieves higher gradient performance due to its reduced inner diameter, specifically tailored for neuroimaging. The asymmetrical design shifts the gradient isocenter to the patient edge of the coil rather than its geometric center, enabling patient head access and avoiding shoulder width constraints. This head-only design allows MAGNUS to deliver a gradient amplitude and slew rate far surpassing those of conventional 60cm or 70cm bore whole-body MRI systems, marking a significant advancement in MRI technology for neuroimaging applications.
"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 and Biomarker Discovery
SIGNA MAGNUS offers exceptional precision, enabling high-resolution, high signal-to-noise ratio imaging, advanced diffusion techniques, and short scan times. To date, four investigational MAGNUS systems have been installed at Walter Reed National Military Medical Center, University of
Dr. Vince A. Magnotta, PhD, Director of the MR Research Facility and Professor of Radiology – Division of Neuroradiology, University of
GE HealthCare has demonstrated leadership in high-performance gradient technology with the introduction of HyperG gradients, one of the most efficient gradient coils on the marketii, in the SIGNA MAGNUS system. The innovative asymmetric head-only design of the HyperG gradient coil invokes significantly less Peripheral Nerve Stimulation (PNS) thus maximizing the actual use of the system’s gradient performance for both clinical and research scanning.
The HyperG gradient technology achieves remarkable 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 mean less time spent in the MRI machine, which is 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. This can result in accurate diagnoses, allowing healthcare providers to detect subtle abnormalities and provide better treatment options.
Clinical and Research Excellence
The enhanced capabilities of the SIGNA MAGNUS system provide ultra-high anatomical resolution with shorter scan times. Its ability to visualize brain function, microstructure, and micro-vasculature through innovations such as ODEN (Oscillating Gradient Diffusion Encoding) which uses oscillating gradients to provide cellularity contrast which can be important for neurological oncology. Our intention is to leverage the high-gradient performance of SIGNA MAGNUS capabilities to allow for advanced research scanning such as high B-value diffusion imaging, fMRI for investigating the BOLD (Blood Oxygen Level Dependent) response and measurement of slow CSF (Cerebral Spinal Fluid) flow. This marks a transformative step forward in advancing neuroscience research.
“We're very excited about the capabilities SIGNA MAGNUS provides,” said Kawin Setsompop, PhD, 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.”
SIGNA MAGNUS will be available for both forward production and upgrades from compatible SIGNA Premier systems. This means that existing facilities can upgrade to this advanced technology, expanding access to high-performance imaging without the need for entirely new systems, additional power or cooling. 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 and psychiatric disorders.
Learn more about SIGNA MAGNUS at the Radiological Society of
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a
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i SIGNA™ MAGNUS is 510(k) cleared with the FDA. Not yet CE Marked. Not available for sale in all regions.
ii GE HealthCare data on file
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Source: GE HealthCare
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