iRhythm received regulatory approval from Japanese PMDA for Zio ECG system

iRhythm Technologies announced that it has received regulatory approval from the Japanese Pharmaceutical and Medical Device Agency, PMDA, for the Zio fourteen-day, long-term continuous ECG monitoring system. With regulatory approval in hand, iRhythm intends to work towards a reimbursement decision for the Zio ECG monitoring system with the Japanese Ministry of Health, Labour, and Welfare, MHLW. “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.”