• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Medical Tubing and Extrusion

Medical tubing and extrusion technologies

  • Technologies
    • Balloons
    • Brain-computer interfaces
    • Cardiac Implants
    • Catheters
    • Endoscopes
    • Heart valves
    • Pulsed Field Ablation
  • Components
    • Connectors
    • Needles and Injections
    • Seals
    • Tubing Components
  • Manufacturing
    • Coatings
    • Extrusions
    • Machining
    • Molding
      • Injection Molding
      • Insert molding
      • Mold Components
    • Tools
  • Materials
    • Advanced Materials
    • Metals
    • Nitinol
    • Plastics
    • Silicone
  • Business
    • Distribution Agreements
    • Legal News
    • Mergers & Acquisitions
    • Partnerships
    • Personnel Moves
  • Regulatory
    • 510(k)
    • CE Mark
    • FDA Breakthrough Designation
    • ISO Certification
    • Pre-Market Approval (PMA)
    • Recalls
  • Suppliers
  • About Us

Acutus Medical wins regulatory approval in Japan for non-contact cardiac mapping catheter

July 29, 2022 By Danielle Kirsh

acutus-medicalAcutus Medical this week announced it received regulatory approval in Japan for its AcQMap high resolution imaging and mapping system and the AcQMap 3D imaging and mapping catheter.

The approval represents a new era of non-contact arrhythmia management in Japan. Acutus Medical and its international alliance partner Biotronik have commenced training and early market development activities to prepare for additional innovations in 2023.

“We are excited to bring this innovative technology to Japan,” said Hans-Jürgen Wildau, segment head of EP and sensors for Biotronik. “These approvals represent another successful milestone in the market readiness work we’ve done with Acutus over the past 24 months. We believe Japanese physicians specifically will appreciate the innovation the Acutus platform brings to the diagnosis of complex arrhythmias, especially in mapping non-pulmonary vein triggers which is a significant unmet need in the treatment for atrial fibrillation.”

Carlsbad, California-based Acutus Medical designed the AcQMap 3D ultrasound-based imaging and non-contact mapping system to capture cardiac imaging information and cardiac activation mapping. The AcQMap system uniquely maps the electrical conduction of each heartbeat to characterize the most complex arrhythmia in the atrial chamber of the heart.

The ability to map every beat allows physicians to visualize global chamber activity of irregular heart rhythm conditions such as atrial fibrillation, complex flutters and tachycardias. The non-contact procedure helps personalize diagnosis and treatment for heart rhythm conditions.

“The AcQMap system and catheter clearance represents a major advancement in the tools available to EPs in Japan,” said David Roman, president & CEO of Acutus Medical. “This approval uniquely enables electrophysiologists in Japan to employ a fully non-contact system to aid in the personalized diagnosis and treatment of patients suffering from cardiac arrhythmias. We view Japan as one of several key growth drivers to accelerate long-term performance. We look forward to entering Japan with Biotronik given its established and respected position in the market.”

Filed Under: Catheters Tagged With: Acutus Medical

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

Primary Sidebar

“mte
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest trends and developments in medical tubing and extrusion.
MDO ad

Sponsored Content

A new way to access scientific papers?

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Inv Logo

MASSDEVICE MEDICAL NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World
Drug Delivery Business News

Medical Tubing + Extrusion

Subscribe to our E-Newsletter
Advertise with us
About
Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS