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.