GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Signa Magnus MRI scanner.
The 3.0T high-performance, head-only scanner offers new capabilities for both clinical imaging and neuroscience. It has the potential to aid in the detection of neurological, oncological and psychiatric conditions, according to a news release.
Signa Magnus features what the company says is an innovative asymmetrical, high-efficiency, head-only gradient coil design. This achieves higher gradient performance due to its reduced inner diameter, specifically tailored for neuroimaging. Its asymmetrical design shifts the gradient isocenter to the patient edge of the coil rather than its geometric center. That enables patient head access and avoids shoulder width constraints.
GE HealthCare says the head-only design allows the system 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.
Signa Magnus delivers precision for high-resolution, high signal-to-noise-ratio imaging, advanced diffusion techniques and short scan times. GE HealthCare says it plans to offer Signa Magnus for both forward production and upgrades from compatible Signa Premier systems. This means existing facilities can upgrade to more advanced technology without the need for entirely new 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 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.”
