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Polarean Imaging Receives FDA Clearance to Expand MRI Chest Coil Compatibility

• Polarean Imaging secured FDA 510k clearance for its MRI chest coil to include GE Healthcare's 3 Tesla MRI scanners, enhancing Xenon-129 nuclei visualization. • The expanded clearance ensures Polarean's Xenon MRI technology is accessible to more institutions and clinicians across the U.S. for lung disease detection. • With this approval, Polarean now supports Xenon MRI scanning from all three major scanner vendors: GE Healthcare, Koninklijke Philips NV, and Siemens Healthineers AG.

Polarean Imaging PLC has received 510k clearance from the U.S. Food & Drug Administration (FDA) to expand the compatibility of its specialized MRI chest coil. The clearance now includes GE Healthcare Technologies Inc's 3 Tesla (3T) MRI scanners for visualizing Xenon-129 nuclei. This advancement significantly broadens the availability of Polarean's innovative Xenon MRI technology across the United States.

Broadening Access to Xenon MRI

The FDA clearance marks a pivotal step for Polarean, ensuring that its Xenon MRI technology can be utilized with MRI systems from all three major vendors: GE Healthcare, Koninklijke Philips NV, and Siemens Healthineers AG. This widespread compatibility is expected to enhance the accessibility of advanced imaging solutions for detecting and monitoring lung diseases.

Executive Perspective

Christopher von Jako, CEO of Polarean Imaging, emphasized the importance of this expansion: "Expanding our FDA clearance to include GE HealthCare's platforms, following our previous clearance for Philips and Siemens systems, ensures that more institutions and clinicians across the US can access our innovative Xenon MRI technology. This expansion further enhances our ability to provide advanced imaging solutions to support patients and clinicians in the detection and ongoing monitoring of lung disease."
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Reference News

[1]
IN BRIEF: Polarean Imaging gets FDA approval for MRI chest coil - Morningstar
morningstar.co.uk · Nov 21, 2024

Polarean Imaging PLC receives 510k clearance from the US FDA for its MRI chest coil to include GE Healthcare's 3T MRI sc...

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