Polarean Imaging announces FDA clearance of XENOVIEW 3T chest coil

Polarean Imaging (PLLWF) has received 510(k) clearance from the U.S. Food and Drug Administration for the Company’s specialized MRI Chest Coil to now include GE HealthCare (GEHC) 3 Tesla MRI scanners for the visualization 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 hyperpolarized Xenon-129 for oral inhalation for the evaluation of lung ventilation in adults and pediatric 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.