Polarean Imaging PLC - London-based medical imaging technology company - Receives 510(k) clearance from the US Food & Drug Administration for its specialised magnetic resonance imaging chest coil. The coil may now include Philips 3.0T MRI scanners for the visualisation of the Xenon-129 nuclei.
The Polarean Xenoview 3.0T Chest Coil is a flexible, single channel, transmit-receive radio-frequency coil tuned to image 129Xe nuclei while a patient is positioned inside a multinuclei-capable MRI scanner. Polarean says that adding the new Philips configuration does not affect the intended use of the device, and that safety and effectiveness has been confirmed with testing.
Chief Executive Officer Christopher von Jako says: ‘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. 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.’
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