US-based digital healthcare company iRhythm Technologies has received Japan’s Pharmaceutical and Medical Device Agency (PMDA) approval for the Zio 14-day, long-term continuous ECG monitoring system.
The regulatory approval allows iRhythm to work towards a reimbursement decision for the Zio ECG monitoring system with the Japanese Ministry of Health, Labour, and Welfare (MHLW).
According to the company, its Zio system represents a significant advancement in cardiac arrhythmia diagnostics compared to traditional Holter monitoring.
The patient care monitoring system is designed to deliver superior clinical accuracy to help doctors make the right diagnosis the first time.
Zio long-term continuous monitoring (LTCM) service includes a prescription-only patch ECG monitoring device, dubbed Zio monitor, worn for up to 14 days.
The service also includes the ZEUS System, iRhythm’s advanced AI algorithm that generates an end-of-wear report reviewed and curated by certified cardiographic technicians.
iRhythm president and CEO Quentin Blackford said: “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.”
iRhythm said its Zio ECG monitoring system is the only 14-day cardiac monitoring device to receive Japanese regulatory approval without a clinical trial.
The system previously received a Japanese high medical needs designation by MHLW, based on positive recommendation by Japan’s Heart Rhythm Society (JHRS).
The designation is based on clinical improvements with Zio services and the significant need for improvement in the detection of potential cardiac arrhythmias in Japan.
Recently, iRhythm signed a licensing agreement with health monitoring firm BioIntelliSense to enhance its ambulatory cardiac monitoring (ACM) capabilities.
