Polarean Imaging PLC (AIM:POLX, OTC:PLLWF), a specialist in advanced lung MRI scanning, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its specialised XENOVIEW 3.0T Chest Coil to now include Philips 3.0T MRI scanners for visualising the Xenon-129 nuclei.
The addition of the Philips configuration does not change the device's intended use, and its safety and effectiveness have been reaffirmed through testing.
This clearance represents a significant expansion in the applicability of Polarean's technology.
"Polarean continues to develop and launch new devices and accessories that empower sites to perform modern respiratory imaging, enabling as many clinicians as possible to use our technology for their patients," said the company CEO, Christopher von Jako.
"This FDA clearance also further supports our recently announced collaboration with Philips, by expanding our product line to be compatible with their advanced MRI systems."
The med-tech specialises in advanced MRI scanning tools and systems for analysing and visualising lung function, with the distinction of having developed the first FDA-approved hyperpolarised MRI contrast agent.