The Japanese Pharmaceutical and Medical Device Agency (PMDA) has approved iRhythm Technologies’ Zio ECG monitoring system, an advanced cardiac arrhythmia diagnostics tool.
The approval sets the stage for iRhythm to work towards a reimbursement decision for the system with the Japanese Ministry of Health, Labour, and Welfare (MHLW).
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The Zio long-term continuous monitoring (LTCM) service includes a wearable patch ECG monitoring device (Zio monitor) and the ZEUS (Zio ECG Utilization Software) System, iRhythm’s proprietary AI algorithm.
The Zio monitor can be worn for up to 14 days.
Designed to provide high clinical accuracy and support physicians in making accurate diagnoses, the Zio system has shown superiority over traditional Holter monitoring in terms of diagnostic capabilities.
iRhythm’s Zio monitor, Zio XT, and Zio AT systems have a presence in the US, with the Zio XT system also available in the UK.
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By GlobalDataThe company has expanded its reach in Europe, launching the Zio monitor in Austria, the Netherlands, Spain, and Switzerland.
Preparations for the Japanese market launch are underway, with iRhythm collaborating with a local distribution partner in anticipation of reimbursement approval by the MHLW.
iRhythm president and CEO Quentin Blackford said: “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.
“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.”
Last year, the US Food and Drug Administration issued a warning letter to iRhythm over regulatory violations related to its single-use cardiac monitoring chest patch.
