GE HealthCare has received the US Food and Drug Administration (FDA) 510(k) clearance for its Signa Magnus, a 3.0T high-performance head-only magnetic resonance imaging (MRI) scanner.
The advanced system enhances clinical imaging and neuroscience and helps detect neurological, oncological, and psychiatric conditions.
Signa Magnus features a new asymmetrical, high-efficiency, head-only gradient coil design customised especially for neuroimaging. This design is said to offer superior gradient performance due to its reduced inner diameter.
According to GE HealthCare, the asymmetrical design shifts the gradient isocenter to the patient edge, providing better head access and eliminating shoulder width limitations.
This head-only system achieves a higher gradient amplitude and slew rate than traditional 60cm or 70cm whole-body MRI systems, setting a new standard in neuroimaging technology, the company said.
Signa Magnus delivers precision with high-resolution, high signal-to-noise ratio imaging. It supports advanced diffusion techniques and enables shorter scan times.
Shorter scan times reduce patient discomfort, especially for those who struggle with claustrophobia.
Stronger gradients improve spatial resolution and image clarity, leading to more accurate diagnoses. This helps detect subtle abnormalities and enables better treatment options.
Currently, GE HealthCare has installed four investigational Magnus systems at Walter Reed National Military Medical Center, the University of Iowa, the University of Wisconsin-Madison, and Brigham and Women’s Hospital.
GE HealthCare MR applications platform and research technologies general manager Jason Polzin said: “Obtaining FDA clearance further validates our commitment to not only innovating but also in delivering clinical technologies that have real-world impact.
“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.”
Other key features include ODEN (Oscillating Gradient Diffusion Encoding) which allows detailed visualisation of brain function, microstructure, and micro-vasculature, crucial for neurological oncology.
The system’s high-gradient performance supports advanced research, including high B-value diffusion imaging, fMRI for BOLD (Blood Oxygen Level Dependent) response, and slow CSF (Cerebral Spinal Fluid) flow measurement.
Signa Magnus will be available for new production and upgrades from compatible Signa Premier systems.
This allows existing facilities to enhance their imaging capabilities without needing new systems, extra power, or additional cooling.
Last month, the medical technology firm launched the Versana Premier multi-purpose ultrasound system.
