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Acutus Medical said its AcQMap High Resolution Imaging and Mapping System and the AcQMap 3D Imaging and Mapping Catheter was approved in Japan.

Acutus said Japan is the 2nd largest medical device market in the world and the EP Mapping and Ablation market is estimated to exceed $1.4 billion in 2022 with more than 150,000 procedures performed and grow to an estimated $1.8 billion by 2025.

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 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.”

The move comes just a few weeks after the company won an FDA nod for the technology. FDA approval was thought to be a return to stable ground for Acutus. In 2021, the company struggled a bit as it said macroeconomic headwinds prompted it to develop a restructuring plan that included a workforce reduction.

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