iRhythm Technologies Announces Japanese Regulatory Approval of the Zio® ECG Monitoring System, the First Product to Deliver Arrhythmia Monitoring Service Utilizing Artificial Intelligence
iRhythm Technologies (NASDAQ:IRTC) has received Japanese regulatory approval for its Zio® ECG Monitoring System, marking a significant milestone in the company's global expansion. The Zio system, which offers 14-day continuous ECG monitoring, is the first in its category to receive approval in Japan without a clinical trial. Key points include:
- Zio previously received a high medical needs designation in Japan
- Japan is the world's second-largest medical device market
- An estimated 1.6 million cardiac monitoring tests are prescribed annually in Japan
- iRhythm will now work towards securing reimbursement for market access
- The Zio system utilizes advanced AI algorithms for arrhythmia detection
This approval positions iRhythm to address the growing need for improved cardiac arrhythmia diagnostics in Japan's aging population.
iRhythm Technologies (NASDAQ:IRTC) ha ricevuto l'approvazione normativa giapponese per il suo sistema di monitoraggio ECG Zio®, segnando una tappa significativa nell'espansione globale dell'azienda. Il sistema Zio, che offre un'monitoraggio ECG continuo di 14 giorni, è il primo della sua categoria ad aver ottenuto l'approvazione in Giappone senza una sperimentazione clinica. I punti chiave includono:
- Zio ha precedentemente ricevuto una designazione per alte esigenze mediche in Giappone
- Il Giappone è il secondo mercato mondiale dei dispositivi medici
- Sono prescritti annualmente circa 1,6 milioni di test di monitoraggio cardiaco in Giappone
- iRhythm lavorerà ora per garantire il rimborso per l'accesso al mercato
- Il sistema Zio utilizza algoritmi avanzati di intelligenza artificiale per la rilevazione delle aritmie
Questa approvazione posiziona iRhythm per rispondere alla crescente necessità di migliorare la diagnosi delle aritmie cardiache nella popolazione anziana del Giappone.
iRhythm Technologies (NASDAQ:IRTC) ha recibido la aprobación regulatoria japonesa para su sistema de Monitoreo ECG Zio®, marcando un hito significativo en la expansión global de la empresa. El sistema Zio, que ofrece monitoreo ECG continuo de 14 días, es el primero de su categoría en recibir aprobación en Japón sin un ensayo clínico. Los puntos clave incluyen:
- Zio había recibido anteriormente una designación de alta necesidad médica en Japón
- Japón es el segundo mercado de dispositivos médicos más grande del mundo
- Se prescriben aproximadamente 1.6 millones de pruebas de monitoreo cardíaco anualmente en Japón
- iRhythm ahora trabajará para asegurar el reembolso para el acceso al mercado
- El sistema Zio utiliza algoritmos avanzados de IA para la detección de arritmias
Esta aprobación posiciona a iRhythm para abordar la creciente necesidad de mejorar el diagnóstico de arritmias cardíacas en la población envejecida de Japón.
iRhythm Technologies (NASDAQ:IRTC)는 자사의 Zio® ECG 모니터링 시스템에 대한 일본 규제 승인을 받았으며, 이는 회사의 글로벌 확장에서 중요한 이정표를 의미합니다. 14일간의 연속 ECG 모니터링을 제공하는 Zio 시스템은 임상 시험 없이 일본에서 승인을 받은 첫 번째 제품입니다. 주요 사항은 다음과 같습니다:
- Zio는 일본에서 높은 의료 필요 지정을 이미 받았습니다.
- 일본은 세계에서 두 번째로 큰 의료 기기 시장입니다.
- 일본에서는 매년 약 160만 건의 심장 모니터링 검사가 처방됩니다.
- iRhythm은 이제 시장 접근을 위한 환급 확보에 나설 것입니다.
- Zio 시스템은 부정맥 탐지를 위한 고급 AI 알고리즘을 사용합니다.
이 승인은 iRhythm이 일본의 노령 인구에서 증가하는 심장 부정맥 진단의 필요를 해결할 수 있는 위치에 놓이게 합니다.
iRhythm Technologies (NASDAQ:IRTC) a reçu l'approbation réglementaire japonaise pour son système de surveillance ECG Zio®, marquant une étape importante dans l'expansion mondiale de l'entreprise. Le système Zio, qui offre un'monitoring ECG continu de 14 jours, est le premier de sa catégorie à avoir obtenu une approbation au Japon sans essai clinique. Les points clés incluent :
- Zio a précédemment reçu une désignation de haute nécessité médicale au Japon
- Le Japon est le deuxième plus grand marché des dispositifs médicaux au monde
- Environ 1,6 million de tests de surveillance cardiaque sont prescrits chaque année au Japon
- iRhythm travaillera désormais à sécuriser le remboursement pour l'accès au marché
- Le système Zio utilise des algorithmes avancés d'IA pour la détection des arythmies
Cette approbation positionne iRhythm pour répondre au besoin croissant d'améliorer le diagnostic des arythmies cardiaques chez la population vieillissante du Japon.
iRhythm Technologies (NASDAQ:IRTC) hat die japanische Zulassung für sein Zio® ECG-Überwachungssystem erhalten, was einen bedeutenden Meilenstein in der globalen Expansion des Unternehmens darstellt. Das Zio-System, das 14-tägige kontinuierliche ECG-Überwachung bietet, ist das erste seiner Art, das in Japan ohne klinische Studie genehmigt wurde. Wichtige Punkte sind:
- Zio erhielt zuvor eine hohe medizinische Bedarfseinstufung in Japan
- Japan ist der zweitgrößte Markt für medizinische Geräte der Welt
- Schätzungsweise 1,6 Millionen Herzüberwachungsuntersuchungen werden jährlich in Japan verordnet
- iRhythm wird nun daran arbeiten, eine Kostenerstattung für den Marktzugang zu sichern
- Das Zio-System nutzt fortschrittliche KI-Algorithmen zur Erkennung von Arrhythmien
Diese Genehmigung positioniert iRhythm, um den wachsenden Bedarf an verbesserten Diagnosen von Herzrhythmusstörungen in der alternden Bevölkerung Japans zu adressieren.
- Received Japanese regulatory approval for Zio ECG Monitoring System
- First product in its category to receive approval without a clinical trial
- Previously received high medical needs designation in Japan
- Potential access to world's second-largest medical device market
- Estimated 1.6 million cardiac monitoring tests prescribed annually in Japan
- AI-powered system with high diagnostic performance similar to cardiologists
- Still needs to secure reimbursement approval for market access in Japan
- Faces competition from established Holter monitoring technology in Japan
Insights
This regulatory approval marks a significant milestone for iRhythm in the world's second-largest medical device market. The Zio ECG monitoring system's approval without clinical trials underscores its innovative nature and potential to disrupt the
The high medical needs designation from the JHRS adds credibility and could expedite the reimbursement process. However, investors should note that market access still hinges on MHLW reimbursement approval, which could take time and impact near-term revenue potential in Japan.
Long-term, iRhythm's AI-driven approach and vast ECG data repository (1.8 billion hours) position it well to capture market share from traditional Holter monitoring, especially given Japan's aging population and increasing cardiovascular disease burden.
iRhythm's ZEUS System represents a leap forward in AI-powered diagnostics. The ability to classify a broad range of arrhythmias with accuracy comparable to cardiologists is a game-changer. This could significantly reduce misdiagnoses and improve clinical efficiency, addressing critical healthcare challenges in Japan's overburdened system.
The 1.8 billion hours of curated ECG data is a massive competitive advantage. This dataset, coupled with deep learning algorithms, creates a formidable barrier to entry for competitors and positions iRhythm for continuous improvement in diagnostic accuracy.
Investors should watch for potential AI-driven expansion into predictive cardiology, which could open new revenue streams and solidify iRhythm's market position.
iRhythm's entry into Japan is a strategic move with significant growth potential. The Japanese market, with 1.6 million annual tests, represents a substantial opportunity. However, investors should be cautious about the timeline for full market penetration, as changing established medical practices can be slow, especially in conservative markets like Japan.
The company's expansion in Europe (Austria, Netherlands, Spain, Switzerland) demonstrates a robust global growth strategy. This diversification reduces reliance on any single market and positions iRhythm for long-term growth.
The letter of intent with a Japanese distribution partner is promising, but details on this partnership and its potential impact on margins will be important for assessing the full financial implications of this market entry.
- Zio ECG monitoring system is the only fourteen-day cardiac monitoring service in its category to receive Japanese regulatory approval as an improved device without a clinical trial
- Zio ECG monitoring system previously received Japanese high medical needs designation, a unique distinction reflecting positive recommendation by the Japanese Heart Rhythm Society (JHRS)
- iRhythm will continue working towards reimbursement to enable market access in Japan, the world’s second largest medical device market
- Japan is the second largest ambulatory cardiac monitoring market in the world with an estimated 1.6 million tests prescribed annually – a number that is expected to continue to increase1-3
SAN FRANCISCO, Sept. 11, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that it has received regulatory approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the Zio® fourteen-day, long-term continuous ECG monitoring system. With regulatory approval in hand, iRhythm intends to work towards a reimbursement decision for the Zio ECG monitoring system with the Japanese Ministry of Health, Labour, and Welfare (MHLW).
Zio long-term continuous monitoring (LTCM) service consists of a prescription only patch ECG monitoring device (Zio monitor) worn for up to 14 days and the ZEUS (Zio ECG Utilization Software) System (iRhythm’s advanced AI algorithm) that generates a comprehensive end-of-wear report reviewed and curated by certified cardiographic technicians. The Zio system represents a significant advancement in cardiac arrhythmia diagnostics compared to traditional Holter monitoring4 and is designed to deliver high clinical accuracy to help enable doctors in making the right diagnosis the first time. iRhythm’s deep learning approach can classify a broad range of distinct arrhythmias with high diagnostic performance similar to that of cardiologists and, in clinical settings, this service could reduce the amount of misdiagnosed computerized ECG interpretations and improve clinical efficiency.5
“With the strong support from our partners at the Japanese Heart Rhythm Society, we are thrilled to receive this approval from the Japanese PMDA as a testament to iRhythm’s commitment to innovation and the highest standards of quality and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are very grateful for their diligent review of our Shonin application as we seek to drive better health outcomes and more equitable access for patients around the globe. We look forward to continuing working closely with the MHLW during their market access and reimbursement review of the Zio service.”
The Zio system was previously designated for high medical needs by the MHLW, a rarely bestowed distinction in Japan that is granted to innovative devices recognized as having high medical utility for significant diseases. The Zio system was indicated for this designation at the recommendation of the JHRS based on the clinical improvements that the Zio services provide compared to traditional Holter monitoring4,5 and the significant need that patients in Japan face to improve detection of potential cardiac arrhythmias.
Japan is the second largest ambulatory cardiac monitoring market in the world with an estimated 1.6 million tests prescribed annually1 – a number that is expected to continue to increase based on stroke and cardiovascular disease burden in an aging population2,3. However, Japanese patients are forced to use Holter monitoring, the traditional standard of care, as patch-based technology, like the Zio service, has not been adopted.
Since the company’s inception, iRhythm has posted over 8 million patient reports and amassed a repository of approximately 1.8 billion hours of curated ECG data7. Zio monitor, Zio XT, and Zio AT (mobile cardiac telemetry) systems are currently available in the U.S., and Zio XT system is available in the UK. Additionally, iRhythm recently announced the commercial launch of Zio monitor in Austria, the Netherlands, Spain, and Switzerland. iRhythm has signed a letter of intent with a distribution partner in Japan and is actively collaborating with them to prepare for market launch once reimbursement is approved by the MHLW.
About iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, including its portfolio of Zio products and services, please visit irhythmtech.com.
Investor Contact
Stephanie Zhadkevich
investors@irhythmtech.com
Media Contact
Kassandra Perry
irhythm@highwirepr.com
- Irie S, Tada H. The Relationship between Holter Electrocardiography and Atrial Fibrillation Diagnosis Using Real-World Data in Japan. Int Heart J. 2023;64(2):178-187.
- Matsuda S. Health Policy in Japan - Current Situation and Future Challenges. JMA Journal, 2019.
- Annual Pharmaceutical Production Statistics, Ministry of Health, Labour, and Welfare (“MHLW”).
- Barrett P. et al. Comparison of 24-hour Holter monitoring vs. 14-day novel adhesive patch electrocardiographic monitoring. American Heart Journal of Medicine, 2014.
- Hannun, AY. et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nature Medicine, 2019.
- Turakhia, M. et al. Diagnostic Utility of a Novel Leadless Arrhythmia Monitoring Device, American Journal of Cardiology, 2013.
- Data on file. iRhythm Technologies, 2024.
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