Polarean's Xenoview 3T gets new FDA clearance

(Sharecast News) - Polarean Imaging announced FDA 510(k) clearance for its Xenoview 3T Chest Coil on Thursday, extending compatibility to GE HealthCare's 3 Tesla (3T) MRI scanners. The AIM-traded firm said the development would enable the use of Polarean's advanced imaging technology for visualising Xenon-129 nuclei across all major MRI vendors, including GE HealthCare, Philips, and Siemens Healthineers.

It described the Xenoview 3T Chest Coil as a flexible, single-channel transmit-receive radiofrequency coil, specifically designed for imaging Xenon-129 nuclei in patients using GE HealthCare's Signa Premier 3T or Discovery MR750 3T scanners equipped with multi-nuclear spectroscopy capability.

Indicated for evaluating lung ventilation in adults and children aged 12 years and older, the device works in conjunction with hyperpolarised Xenon-129 for oral inhalation.

Polarean said the FDA clearance confirmed the safety and effectiveness of the technology, broadening accessibility for clinical and research applications.

"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 chief executive officer Christopher von Jako.

"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 US 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."

At 1501 GMT, shares in Polarean Imaging were up 3.08% at 1,57p.

Reporting by Josh White for Sharecast.com.