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FX.co ★ IRhythm Gets Japanese PMDA Approval For Zio ECG Monitoring System

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typeContent_19130:::2024-09-11T13:40:00

IRhythm Gets Japanese PMDA Approval For Zio ECG Monitoring System

**iRhythm Technologies Secures Approval for Zio ECG Monitoring System in Japan**

iRhythm Technologies, Inc. (IRTC), a leading digital health care provider, announced on Wednesday that it has received approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for its Zio ECG monitoring system. This innovative system leverages artificial intelligence to deliver advanced arrhythmia monitoring services.

The Zio long-term continuous monitoring service features a patch ECG device worn for up to 14 days, and the ZEUS (Zio ECG Utilization Software) System, which compiles a detailed report analyzed by certified cardiographic technicians.

Japan represents the world's second-largest market for ambulatory cardiac monitoring, with an estimated 1.6 million tests prescribed annually.

iRhythm aims to secure a reimbursement decision for the Zio ECG monitoring system from the Japanese Ministry of Health, Labour, and Welfare (MHLW).

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