The Japanese Pharmaceutical and Medical Device Agency (PMDA) approved the 14-day wearable ECG system. San Francisco-based iRhythm now plans to work toward a reimbursement decision for Zio with the Japanese Ministry of Health, Labour, and Welfare (MHLW). The system previously held the designation for high medical needs by the MHLW.

Zio builds on the previous-generation Zio XT with long-term, continuous cardiac monitoring for up to 14 days. It provides an end-to-end experience for patients with potential arrhythmias and demonstrates 99% patient compliance. iRhythm launched the next-generation monitor in the U.S. in September.

iRhythm also kicked off the launch of its Zio monitoring service in Austria, the Netherlands, Spain and Switzerland last month. The technology, along with the supporting Zeus AI algorithm, picked up CE mark at the start of the year.

The Zio system’s deep learning approach can classify a broad range of distinct arrhythmias with high diagnostic performance. In clinical settings, it could reduce the amount of misdiagnosed computerized ECG interpretations and improve clinical efficiency.

“With the strong support from our partners at the Japanese Heart Rhythm Society, we are thrilled to receive this approval from the Japanese PMDA as a testament to iRhythm’s commitment to innovation and the highest standards of quality and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are very grateful for their diligent review of our Shonin application as we seek to drive better health outcomes and more equitable access for patients around the globe. We look forward to continuing working closely with the MHLW during their market access and reimbursement review of the Zio service.”