Polarean Imaging PLC (AIM:POLX, OTC:PLLWF) has received FDA 510(k) clearance for its XENOVIEW 3T chest coil to be used with GE HealthCare 3 Tesla (3T) MRI systems.
The clearance allows the use of the device to support lung imaging using hyperpolarised Xenon-129 for oral inhalation in adults and children aged 12 and older.
It works with GE MRI models, including the SIGNA Premier 3T and Discovery MR750 3T, equipped with multi-nuclear spectroscopy.
Polarean CEO Christopher von Jako said: "GE HealthCare is a global leader in MRI technology and we are delighted to now offer our XENOVIEW 3T chest coil for use on their cutting-edge 3T MRI systems.
"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 U.S. 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."
The XENOVIEW 3T chest coil is designed to visualise lung ventilation in clinical and research patients. Its safety and effectiveness were confirmed through testing.
This clearance makes Polarean’s technology compatible with all major MRI vendors, including GE HealthCare, Philips, and Siemens Healthineers.
The company said the approval expands access to advanced lung imaging for institutions using GE MRI systems.
FDA 510(k) clearance confirms that a medical device is safe and effective, and substantially equivalent to an already legally marketed device.