GE HealthCare gets FDA clearance for ‘head-only’ SIGNA MAGNUS 3.0T MRI

GE HealthCare (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. 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.”