Zio ECG Monitor and ZEUS AI System Receive CE Marking

Head and shoulders shot of woman wearing a cardiac monitor adhered to upper chest.

Image credit: iRhythm Technologies

US-based medtech, iRhythm Technologies has received CE marking for its next-generation long-term ambulatory cardiac monitor and related artificial intelligence (AI) algorithm.

Developed to detect potential cardiac arrhythmias, the Zio monitor system is supported by the ZEUS (Zio ECG Utilization Software) deep-learned AI algorithm.

Launched in the United States in September last year, iRhythm anticipates widespread access in 2024.

“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 said in a press statement.

“With the EU MDR [medical device regulation] 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.”

Check out the full press release for further details, or learn more about the monitoring system in the video below.

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