GE HealthCare's Head-Only MRI System Gets FDA Clearance

(RTTNews) - GE HealthCare Technologies Inc. (GEHC) Wednesday said that it has received FDA 510(k) clearance for its innovative SIGNA MAGNUS 3.0T high-performance, head-only magnetic resonance imaging or MRI scanner.

SIGNA MAGNUS offers exceptional precision, enabling high-resolution, high signal-to-noise ratio imaging, advanced diffusion techniques, and short scan times.

The 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 company noted that the SIGNA MAGNUS will be available for both forward production and upgrades from compatible SIGNA Premier systems. 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.

The new system 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.

Jason Polzin, GM, MR Applications Platform and Research Technologies, GE HealthCare, said, "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."

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.

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