Acutus Medical Obtains MDR CE Mark of the AcQMap 3D Imaging and Mapping Catheter
06 December 2022 - 10:00PM
Acutus Medical, Inc. (“Acutus” or “the Company”) (Nasdaq: AFIB), an
arrhythmia management company focused on improving the way cardiac
arrhythmias are diagnosed and treated, today announced receipt of a
CE Mark issued under the European Union (EU) Medical Device
Regulations (MDR) for its AcQMap 3D Imaging and Mapping Catheter,
the world’s only integrated high-resolution ultrasound imaging and
non-contact mapping catheter.
The EU MDR was established to create a more robust legislative
framework to better protect public health and patient safety.
Acutus will file for EU MDR approval for the remaining products in
the Company’s portfolio to ensure compliance by the May of 2024
deadline. This will allow physicians to have long-term access to
the Company’s full portfolio of differentiated mapping, ablation,
and EP accessory products.
“Obtaining our MDR CE Mark for AcQMap well before the transition
date ensures that European patients and physicians will have
continued access to our unique mapping technology offering
individualized diagnosis and a personalized treatment plan for even
the most complex arrhythmias,” said Shibaji Shome, Vice
President, Marketing at Acutus. “The MDR, with a significant focus
on quality and safety, is well aligned with our commitment to
improve patient care through innovative and high-quality medical
devices. Importantly, this approval positions us well for further
expansion and growth within the European markets.”
In addition, the Company received MDR certification of its
quality management system.
To learn more about Acutus Medical’s complete portfolio of
diagnostic, access and therapy products, please visit
https://acutusmedical.com.
About Acutus MedicalAcutus Medical is an
arrhythmia management company focused on improving the way cardiac
arrhythmias are diagnosed and treated. Acutus is committed to
advancing the field of electrophysiology with a unique array of
products and technologies which will enable more physicians to
treat more patients more efficiently and effectively. Through
internal product development, acquisitions and global partnerships,
Acutus has established a global sales presence delivering a broad
portfolio of highly differentiated electrophysiology products that
provide its customers with a complete solution for catheter-based
treatment of cardiac arrhythmias. Founded in 2011, Acutus is based
in Carlsbad, California.
Follow Acutus Medical on: Twitter, LinkedIn,
YouTube and Facebook.
Investor ContactCaroline Corner
415-202-5678caroline.corner@westwicke.com
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