iRhythm Technologies, Inc. announced the commercial launch in Japan of its Zio long-term continuous ECG monitoring (LTCM) system, commercially introduced in this market as the Zio ECG Recording and Analysis System. The system provides up to 14 days of continuous, uninterrupted ECG monitoring and leverages a deep-learned artificial intelligence (AI) algorithm approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) – and represents a significant advancement over other ambulatory cardiac monitoring options in Japan, including commonly used wired Holter monitors, which capture only 24 to 48 hours of data and other patch-based services that monitor only up to 7 days.
“We are honored to introduce our AI-powered Zio ECG Recording and Analysis System that provides up to 14 days of continuous, uninterrupted cardiac monitoring to Japan, where we see a meaningful opportunity to help advance arrhythmia detection,” said Quentin Blackford, President and Chief Executive Officer of iRhythm. “Together with our trusted distribution partner, Senko Medical Instrument, we are committed to expanding access to advanced cardiac monitoring that supports clinical excellence and aligns with Japan’s dedication to high-quality, patient-centered care.”
Advancing Arrhythmia Detection in Japan
The Zio ECG Recording and Analysis System consists of a prescription-only, patch-based ECG monitoring device (Zio monitor, iRhythm’s latest-generation ECG patch), worn for up to 14 days, and the ZEUS (Zio ECG Utilization Software) system.
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The unique attributes of the Zio ECG Recording and Analysis System offer meaningful advantages for patients and clinicians:
Zio monitor (Patch ECG Device): Improving Patient Monitoring Experience
- The latest-generation patch ECG is thinner, lighter, and smaller—designed for comfortable, discreet wear, ease of use, and patient satisfaction5,6
- Enables up to 14 days of continuous, uninterrupted ECG monitoring
- Demonstrates 99% patient compliance with prescribed wear time and 99% analyzable data, delivering high-quality, actionable data
Zio Service (End-to-End Monitoring System): Combining Advanced AI with Human Expertise
- PMDA-approved, deep-learned AI algorithm detects 13 arrhythmia types, as well as sinus rhythm and artifact, and is clinically proven to perform at the level of cardiologists
- End-of-wear reports are reviewed and validated by certified cardiographic technicians (CCTs), with 99% physician agreement
- Zio ECG Recording and Analysis System is associated with the highest diagnostic yield and lowest likelihood of retesting compared to other monitoring services, including other LTCMs and 24- to 48-hour duration Holter monitoring services
- In clinical settings, the Zio LTCM service may help reduce misinterpretation of ECG data and improve clinical efficiency
The clinical value of the Zio LTCM service has been demonstrated in a robust, growing body of clinical evidence. The Cardiac Ambulatory Monitor EvaLuation of Outcomes and Time to Events (CAMELOT) study, published in the American Heart Journal, found that Zio LTCM service was associated with the highest yield of specified arrhythmia diagnosis and the lowest likelihood of repeat testing compared to all other monitoring services.
iRhythm’s comprehensive clinical evidence, encompassing more than 125 original research manuscripts and insights derived from over 2 billion hours of curated heartbeat data and more than 10 million patient reports posted since the company’s inception, underscore the company’s ongoing commitment to expanding evidence that supports improved patient outcomes.
SOURCE: GlobeNewsWire
