FDA Grants Expanded 510(k) Clearance for Xenoview 3T MRI Chest Coil in GE HealthCare MRI Platforms
Utilized in conjunction with hyperpolarized Xenon-129 for the assessment of lung ventilation, the chest coil can now be employed in the Signa Premier and Discovery MR750 3T MRI systems.
The Food and Drug Administration (FDA) has expanded 510(k) clearance for the use of the Xenoview 3T MRI Chest Coil in 3T MRI platforms from GE HealthCare.
The chest coil, which facilitates evaluation of lung ventilation in concert with the hyperpolarized contrast agent Xenoview, was previously cleared by the FDA for use in MRI scanners from Philips and Siemens Healthineers, according to Polarean, the developer of the Xenoview 3T Chest Coil and Xenoview.
Specifically indicated for lung ventilation assessment in adults and pediatric patients 12 years and older, the flexible, single-channel radiofrequency coil is tuned to image Xenon-129 nuclei. Polarean said the clearance facilitates expanded access to hyperpolarized MRI technology for high-risk patients with lung disease.
“Expanding our FDA clearance to include GE HealthCare’s platforms, following our previous clearance for Philips and Siemens systems, ensures that more institutions and clinicians across the U.S. can access our innovative Xenon MRI technology. This expansion further enhances our ability to provide advanced imaging solutions to support patients and clinicians in the detection and ongoing monitoring of lung disease,” added Christopher von Jako, the CEO of Polarean.
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