LONDON: Polarean Imaging plc (AIM: POLX), a commercial-stage medical imaging technology leader in advanced Magnetic Resonance Imaging (“MRI”) of lung function, announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s specialised MRI Chest Coil to now include GE HealthCare 3 Tesla (3T) MRI scanners for the visualisation of Xenon-129 nuclei.
With this new introduction, the Company now supports Xenon MRI scanning of both clinical and research patients on all three major MRI scanner vendors: GE HealthCare, Philips, and Siemens Healthineers.
Polarean’s GE HealthCare compatible XENOVIEW® 3T Chest Coil is a flexible, single-channel, transmit-receive radiofrequency coil tuned to image Xenon-129 nuclei while a patient is positioned inside a GE HealthCare SIGNA™ Premier 3T or Discovery MR750 3T MRI scanner equipped with their Multi-Nuclear Spectroscopy capability. The XENOVIEW 3T Chest Coil is indicated to be used in conjunction with hyperpolarised Xenon-129 for oral inhalation for the evaluation of lung ventilation in adults and paediatric patients, aged 12 years and older. The addition of the new Chest Coil seamlessly supports institutions with GE HealthCare compatible MRI systems looking to adopt Xenon MRI, with safety and effectiveness confirmed through testing and FDA clearance.
Christopher von Jako, Ph.D., CEO of Polarean, commented: “GE HealthCare is a global leader in MRI technology and we are delighted to now offer our XENOVIEW 3T Chest Coil for use on their cutting-edge 3T MRI systems.
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.”
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