Polarean Receives Clearance for New MRI Chest Coil
03 August 2023 - 2:08PM
Polarean (AIM: POLX) (“Polarean” or the “Company”), a
commercial-stage medical device leader in advanced MRI scanning of
the lungs, announces it has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for the Company’s specialized
MRI chest coil to now include Philips 3.0T MRI scanners for the
visualization of the Xenon-129 (129Xe) nuclei.
The Polarean XENOVIEW™ 3.0T Chest Coil is a
flexible, single channel, transmit-receive RF coil tuned to image
129Xe nuclei while a patient is positioned inside a
multinuclei-capable MRI scanner. The XENOVIEW Chest Coil is
indicated to be used in conjunction with compatible 3.0T MRI
scanners and approved hyperpolarized 129Xe for oral inhalation for
the evaluation of lung ventilation in adults and pediatric
patients, aged 12 years and older. The addition of the new Philips
configuration does not affect the intended use of the device; the
safety and effectiveness has been confirmed with testing.
Christopher von Jako, CEO of Polarean,
said: “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.”
About Polarean
(www.polarean.com)
The Company and its wholly owned subsidiary,
Polarean, Inc. (together the "Group") are revenue-generating,
medical imaging technology companies operating in the
high-resolution medical imaging space. Polarean aspires to
revolutionize pulmonary medicine by bringing the power and safety
of MRI to the respiratory healthcare community in need of new
solutions to evaluate lung ventilation, diagnose disease,
characterize disease progression, and monitor response to
treatment. By researching, developing, and commercializing novel
imaging solutions with a non-invasive and radiation-free functional
imaging platform. Polarean’s vision is to help address the global
unmet medical needs of more than 500 million patients worldwide
suffering with chronic respiratory disease. Polarean is a leader in
the field of hyperpolarization science and has successfully
developed the first and only hyperpolarized MRI contrast agent to
be approved in the United States. The company also commercializes
systems (such as the HPX hyperpolarization system), accessories
(such as Xe-specific chest coils and phantoms) and FDA-cleared
post-processing software (to support ventilation defect analysis),
to support fully integrated modern respiratory imaging
operations.
Contacts:
Polarean:Chuck OsborneChief Financial Officer+1
(919) 206-7900, ext. 117cosborne@polarean.com
Investors:Anna Dunphy / Phillip Marriage+44 (0)20
7933 8780polarean@wallbrookpr.com
Media Contact:Director of Marketing &
LogisticsMichelle Caissie+1 (919) 206-7900, ext.
136mcaissie@polarean.com
POL-PR-2309
Polarean:
Chuck Osborne
Chief Financial Officer
+1 (919) 206-7900, ext. 117
cosborne@polarean.com
Investors:
Anna Dunphy / Phillip Marriage
+44 (0)20 7933 8780
polarean@wallbrookpr.com
Media Contact:
Michelle Caissie
Director of Marketing & Logistics
+1 (919) 206-7900, ext. 136
mcaissie@polarean.com
Polarean Imaging (LSE:POLX)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Polarean Imaging (LSE:POLX)
Historical Stock Chart
Von Mai 2023 bis Mai 2024