Posted by Michael Wonder on 08 Oct 2020
NDA submission for Polarean’s hyperpolarised 129 Xenon gas drug-device diagnostic for lung imaging
7 October 2020 - Polarean Imaging announces its submission of a new drug application and request for priority review to the US FDA for hyperpolarised 129Xenon gas used to evaluate pulmonary function and to visualise the lung using MRI.
The submission of the new drug application follows the Company’s successful completion of two Phase 3 clinical trials which demonstrated effective measurement of regional lung ventilation.
