FDA accepts Polarean's medical imaging drug-device resubmission

Medical imaging technology company Polarean Imaging updated the market on its investigational drug‑device combination product on Wednesday, which uses hyperpolarised ‘129Xenon’ gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine.

The AIM-traded firm said the United States Food and Drug Administration (FDA) accepted the resubmission of its new drug application (NDA) as a complete response.

It said the FDA established a user fee goal date of 30 September 2022.

“We are happy that the FDA has accepted our resubmission and look forward to resuming the review process with them in the expanded context of our response,” said chief executive officer Richard Hullihen.

At 1221 BST, shares in Polarean Imaging were up 0.4% at 55.22p.