iRhythm Technologies has announced that its long-term ambulatory cardiac monitor, the Zio monitor ECG system, has received CE mark certification under the European Union’s Medical Device Regulation (MDR) from its notified body, the BSI Group.
The Zio monitor ECG system secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias.
Zio monitor builds on the high performance of Zio XT that, together with its enhanced long term continuous cardiac monitoring service, provides an elevated end-to-end experience to patients with potential arrhythmias and demonstrates 99% patient compliance with prescribed wear times, iRhythm said in a press release.
Furthermore, the certification incorporates CE mark for the ZEUS (Zio ECG Utilization Software) system, iRhythm’s deep-learned AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor.
“The EU MDR is arguably one of the most stringent regulatory frameworks for product approvals globally that ensures medical devices meet the rigorous standards for healthcare technologies,” said Quentin Blackford, iRhythm president and chief executive officer. “Receiving this CE mark certification for our Zio monitor and ZEUS system reflects our team’s commitment to delivering the highest quality services as we seek to drive better health outcomes and more equitable access for patients around the globe. Our teams did an excellent job to effectively convey the significant body of clinical study evidence underlying our Zio services and our deep-learned AI algorithm as key differentiators. With improved clinical accuracy compared to existing traditional Holter monitoring, we look forward to introducing our innovative technology to many more patients in Europe.”
In Europe, there remains significant unmet clinical need for improved arrhythmia detection in many countries as the prevalence of arrhythmias and stroke continues to rise, the company says. With the EU MDR CE mark for the Zio monitor and ZEUS systems in hand, iRhythm plans to continue its market expansion strategy in prioritised countries across Europe where there are approximately 1.8 million ambulatory cardiac monitoring tests performed annually.
