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Medical technology & services

Polarean Imaging makes FDA supplemental submission to US FDA

Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) has submitted a New Drug Application supplement to the US Food & Drug Administration to allow XENOVIEW use in paediatric patients aged six years and older. The submission includes updates and new dose delivery bag sizes.

XENOVIEW, made from the Xenon Xe 129 gas blend, is currently used as a hyperpolarized contrast agent for MRI lung ventilation evaluations in adults and children aged 12 years and older.

"If granted, this will allow our technology to help even more children with chronic lung conditions and their clinicians, allowing for better management of their disease. I look forward to further updating the market in due course," said CEO Christopher von Jako.

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