SAN FRANCISCO - iRhythm Technologies, Inc. (NASDAQ:IRTC), a digital health care company, has announced that its Zio ECG monitoring system received regulatory approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA). The Zio system, which includes a wearable patch for continuous ECG monitoring and advanced AI analysis software, is the first of its kind to be approved in Japan without a clinical trial, thanks to its prior designation for high medical needs.
The Zio system is designed to improve the accuracy of cardiac arrhythmia diagnosis over traditional Holter monitors, potentially reducing misdiagnoses and increasing clinical efficiency. The Zio ECG monitoring system can record up to 14 days of continuous ECG data, which is analyzed by iRhythm's proprietary AI algorithm, ZEUS, to produce a comprehensive report.
The approval in Japan marks a significant milestone for iRhythm as the country represents the world's second-largest ambulatory cardiac monitoring market with approximately 1.6 million tests prescribed annually. This number is expected to rise due to the growing prevalence of cardiovascular diseases in Japan's aging population.
iRhythm's President and CEO, Quentin Blackford, expressed gratitude for the support from the Japanese Heart Rhythm Society and the PMDA. The company is now focusing on obtaining reimbursement approval from the Japanese Ministry of Health, Labour, and Welfare, which would facilitate market access.
The Zio service was previously recognized by the Japanese Heart Rhythm Society for its clinical improvements and significant medical utility. iRhythm has a history of over 8 million patient reports and has collected around 1.8 billion hours of curated ECG data. The Zio monitors are already available in the U.S. and the UK, with recent launches in several European countries.
iRhythm has also signed a letter of intent with a distribution partner in Japan to prepare for the market launch pending reimbursement approval. The company continues to expand its global presence, aiming to improve patient outcomes and access to cardiac monitoring technologies.
This news is based on a press release statement from iRhythm Technologies, Inc.
In other recent news, iRhythm Technologies has seen significant developments. The digital healthcare firm reported a 19.3% year-over-year revenue growth, reaching $148 million, leading to an updated revenue forecast for 2024 to between $580 and $590 million. Furthermore, the company has entered into an exclusive licensing agreement with BioIntelliSense, Inc., broadening its ambulatory cardiac monitoring offerings.
The company's next-generation Zio monitor has exhibited improved performance in terms of wear duration and analyzable time compared to its predecessor, the Zio XT. The device has been worn by over a million patients since its late 2023 launch. Additionally, iRhythm has expanded its Zio monitor and service to Austria, the Netherlands, Spain, and Switzerland.
Oppenheimer has maintained its Outperform rating for iRhythm Technologies, despite concerns over the recent GUARD-AF trial results. The company is also contending with a Department of Justice inquiry, actively preparing to oppose the DOJ's petition regarding attorney-client privilege. These represent some of the recent developments for iRhythm Technologies.
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