Polarean Imaging PLC Clearance received for new MRI chest coil (1084I)
03 August 2023 - 4:00PM
UK Regulatory
TIDMPOLX
RNS Number : 1084I
Polarean Imaging PLC
03 August 2023
3 August 2023
Polarean Imaging Plc
("Polarean" or the "Company")
Polarean Receives Clearance for New MRI Chest Coil
Additional clearance for new MRI chest coil further supports the
recently announced collaboration with
Philips
Polarean Imaging Plc (AIM: POLX), 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 specialised MRI chest coil
to now include Philips 3.0T MRI scanners for the visualisation of
the Xenon-129 (129Xe) nuclei .
The Polarean XENOVIEW (TM) 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 hyperpolarised 129Xe for
oral inhalation for the evaluation of lung ventilation in adults
and paediatric 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."
Enquiries:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Christopher von Jako, Chief Executive Via Walbrook PR
Officer
Kenneth West, Chairman
Stifel Nicolaus Europe Limited (NOMAD and
Sole Corporate Broker) +44 (0)20 7710 7600
Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare
Investment
Banking)
Nick Adams / Nick Harland (Corporate Broking)
Walbrook PR Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
Anna Dunphy / Phillip Marriage Mob: +44 (0)7876 741 001 / +44 (0)
7867 984 082
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 revolutionise 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, characterise disease progression,
and monitor response to treatment. By researching, developing, and
commercialising 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 hyperpolarisation
science and has successfully developed the first and only
hyperpolarised MRI contrast agent to be approved in the United
States. The company also commercialises systems (such as the HPX
hyperpolarisation 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.
PLC-RNS-2316
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August 03, 2023 02:00 ET (06:00 GMT)
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