IRhythm Gets Japanese PMDA Approval For Zio ECG Monitoring System

(RTTNews) - iRhythm Technologies, Inc. (IRTC), a digital health care company, Wednesday said it has received approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the company's Zio ECG monitoring system, which utilizes artificial intelligence to deliver Arrhythmia monitoring service.

Zio long-term continuous monitoring service consists of a patch ECG monitoring device worn for up to 14 days, and the ZEUS (Zio ECG Utilization Software) System generates a report reviewed and curated by certified cardiographic technicians.

Japan is the second largest ambulatory cardiac monitoring market in the world with an estimated 1.6 million tests prescribed annually.

iRhythm plans to work towards a reimbursement decision for the Zio ECG monitoring system with the Japanese Ministry of Health, Labour, and Welfare (MHLW).