iRhythm Technologies Receives CE Mark for Zio® Monitor and ZEUS System
iRhythm Technologies has received CE Mark certification under the European Union’s Medical Device Regulation 2017/745 for its next-generation long-term ambulatory cardiac monitor, the Zio monitor ECG System.
The certification incorporates CE mark for the ZEUS (Zio ECG Utilization Software) System, iRhythm’s advanced deep-learned AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor.
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. The new Zio monitor is thinner, lighter, and smaller compared to Zio XT to provide a more inconspicuous wear experience.
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. With the EU MDR CE mark for the Zio monitor and ZEUS systems in hand, iRhythm plans to continue its market expansion strategy in prioritized countries across Europe where there are approximately 1.8 million ambulatory cardiac monitoring tests performed annually.
