FDA OKs XenoView 3T Chest Coil in GE HealthCare MRIs

Polarean Imaging has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its specialized chest coil to now include GE HealthCare 3T MRI scanning for visualization of Xenon-129 nuclei.

The company now supports Xenon MRI scanning of clinical and research patients on all three major MRI vendors: GE HealthCare, Philips, and Siemens Healthineers.

The XenoView 3T chest coil is a flexible, single-channel, transmit-receive radiofrequency (RF) coil tuned to image Xenon-129 nuclei while the patient is positioned in a GE HealthCare Signa Premier 3T or Discovery MR750 3T MRI equipped with their multi-nuclear spectroscopy capability. It’s indicated for use in conjunction with hyperpolarized Xenon-129 for oral inhalation to evaluate lung ventilation in patients aged 12 and older.

Polarean said the new chest coil supports facilities with GE HealthCare-compatible MRI systems seeking to adopt Xenon MRI. It has safety and effectiveness confirmed through testing and FDA clearance.

“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,” said Polarean CEO Christopher von Jako, Ph.D. “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.”