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The Zio service is a long-term continuous ambulatory cardiac monitoring service. It consists of the Zio monitor that collects beat-to-beat ECG data and can be worn for up to 14 days; the ZEUS deep learned algorithm which produces reports; and the final review by a team of Cardiac Physiologists. Preliminary findings from the Zio report are intended for use by clinicians as an aid in arrhythmia diagnosis and management.

Indications for Use: the Zio monitor is a prescription-only, single-use ambulatory ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients 18 years and older, who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.

Contraindications: Do not use the Zio monitor for critical care patients or for patients with symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the patients or when real-time or in-patient monitoring should be prescribed. (Refer to the Zio monitor Instructions for Use for the full list of contraindications.)

Zio monitor, ZEUS and Zio service are currently available in Austria, Netherlands, Spain, Switzerland, UK and USA. Zio monitor and ZEUS are CE-marked. Zio and ZioSuite are registered trademarks of iRhythm Technologies, Inc. in the United States of America.

Studies and data represent the US patient population only. Results may not apply to UK, EU and other populations.

References

1. Data on file. iRhythm Technologies, 2022-2023.

2. Analyzable time is based off 14-day prescription.

3. Zio™ LTCM devices refers to Zio™ monitor device.

4. Based on the US data.

5. Based on the US and UK data using Zio™ ECG monitors.

6. Zio™service provides continuous, uninterrupted recording and a comprehensive end-of-wear report.

7. Zio™ monitor Instructions for Use. iRhythm Technologies, 2023.

8. Data on file. iRhythm Technologies 2020.

9. Hannun et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nat Med. 2019;25:65-69.https://doi.org/10.1038/s41591-018-0268-3

10. Deep-learned algorithm is only available in the United States, European Union, and United Kingdom.

11. FDA 510K clearance, CE mark, and UKCA mark.

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