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GE HealthCare Receives FDA Clearance for Head-Only SIGNA MAGNUS 3.0T MRI System
New MRI technology aims to advance neuroimaging and biomarker research CHICAGO--(BUSINESS WIRE)-- GE HealthCare (Nasdaq: GEHC) has received FDA 510(k)
About this update from Ge Healthcare Technologies Inc.
[{"type":"text","content":"\n\nNew MRI technology aims to advance neuroimaging and biomarker research\n\n\n\n CHICAGO--(BUSINESS WIRE)--\nGE HealthCare (Nasdaq: GEHC) has received FDA 510(k) clearance for its innovative SIGNA™ MAGNUS,i a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This system offers new capabilities for both clinical imaging and neuroscience with the potential to aid in the detection of neurological, oncological, and psychiatric conditions.\n\n\nThe 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.\n\n\n\"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.\"\n\n\nA New Standard for Neuroimaging and Biomarker Discovery\n\n\nSIGNA 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 Iowa, University of Wisconsin – Madison and Brigham and Women’s Hospital.\n\n\nDr. Vince A. Magnotta, PhD, Director of the MR Research Facility and Professor of Radiology – Division of Neuroradiology, University of Iowa, praised the FDA clearance, stat...