Friday, August 04, 2023
Polarean, a leading medical device company specializing in advanced MRI scanning of the lungs, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its specialized MRI chest coil. The newly cleared chest coil includes compatibility with Philips 3.0T MRI scanners, allowing for the visualization of Xenon-129 (129Xe) nuclei.
Known as the Polarean XENOVIEW™ 3.0T Chest Coil, this flexible, single-channel, transmit-receive RF coil is specifically designed to image 129Xe nuclei while a patient undergoes scanning inside a multi-nuclei-capable MRI scanner. The intended use of the XENOVIEW Chest Coil is in conjunction with compatible 3.0T MRI scanners and approved hyperpolarized 129Xe for oral inhalation. It is indicated for evaluating lung ventilation in adult and pediatric patients aged 12 years and older. The recent addition of the Philips configuration does not affect the safety and effectiveness of the device, as it has undergone rigorous testing.
Christopher von Jako, CEO of Polarean, expressed the company's commitment to providing modern respiratory imaging solutions. This FDA clearance further strengthens their collaboration with Philips and expands their product line to be compatible with Philips' advanced MRI systems.