Japanese approval of Acutus imaging and mapping systems


Acutus Medical has announced approval of its AcQMap high resolution imaging and mapping system and the AcQMap 3D imaging and mapping catheter in Japan.

Acutus’ International Alliance partner Biotronik has commenced training and early market development activities in collaboration with Acutus Medical in preparation for more significant activities in 2023.

“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 personalised 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.”

“We are excited to bring this innovative technology to Japan,” said Hans-Jürgen Wildau, segment head EP & sensors, Biotronik. “These approvals represent another successful milestone in the market readiness work we have 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.”


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