iRhythm Technologies Receives FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device
iRhythm Technologies (NASDAQ:IRTC) has received FDA 510(k) clearance for design updates previously made to its Zio AT device. The Zio AT, along with the Zio ECG Utilization Software (ZEUS), enables ambulatory Mobile Cardiac Telemetry (MCT) monitoring for non-critical care patients. This clearance is related to modifications and enhancements made via letter to file and demonstrates iRhythm's commitment to quality, compliance, and performance.
CEO Quentin Blackford stated that this is the first of two 510(k) clearances submitted at the beginning of the year, with the company expecting to hear about the second one soon. Both submissions are part of ongoing remediation efforts with the FDA. iRhythm remains committed to patient safety, physician trust in Zio AT's clinical performance, service quality, and regulatory compliance.
iRhythm Technologies (NASDAQ:IRTC) ha ricevuto l'approvazione FDA 510(k) per gli aggiornamenti di design precedentemente apportati al dispositivo Zio AT. Lo Zio AT, insieme al Software di Utilizzo ECG Zio (ZEUS), consente il monitoraggio della Telemetria Cardiaca Mobile Ambulatoriale (MCT) per pazienti non critici. Questa approvazione è correlata a modifiche e miglioramenti effettuati tramite lettera di file e dimostra l'impegno di iRhythm per la qualità, la conformità e le prestazioni.
Il CEO Quentin Blackford ha dichiarato che questo è il primo di due approvazioni 510(k) presentate all'inizio dell'anno, con l'azienda che si aspetta di ricevere presto notizie sulla seconda. Entrambi i prodotti sono parte degli sforzi di rimedio in corso con la FDA. iRhythm rimane impegnata nella sicurezza dei pazienti, nella fiducia dei medici nelle prestazioni cliniche dello Zio AT, nella qualità del servizio e nella conformità normativa.
iRhythm Technologies (NASDAQ:IRTC) ha recibido la aprobación de la FDA 510(k) para las actualizaciones de diseño previamente realizadas en su dispositivo Zio AT. El Zio AT, junto con el Software de Utilización ECG Zio (ZEUS), permite el monitoreo de Telemetría Cardíaca Ambulatoria (MCT) para pacientes no críticos. Esta aprobación está relacionada con modificaciones y mejoras realizadas mediante carta a archivo y demuestra el compromiso de iRhythm con la calidad, el cumplimiento y el rendimiento.
El CEO Quentin Blackford declaró que esta es la primera de dos aprobaciones 510(k) presentadas a principios de año, y la empresa espera recibir noticias sobre la segunda pronto. Ambas presentaciones son parte de los esfuerzos de remediación en curso con la FDA. iRhythm sigue comprometida con la seguridad del paciente, la confianza de los médicos en el rendimiento clínico del Zio AT, la calidad del servicio y el cumplimiento regulatorio.
iRhythm Technologies (NASDAQ:IRTC)는 Zio AT 장치에 대해 이전에 수행된 디자인 업데이트에 대해 FDA 510(k) 승인을 받았습니다. Zio AT는 Zio ECG 활용 소프트웨어 (ZEUS)와 함께 비응급 환자를 위한 원거리 모바일 심장 모니터링(MCT)을 가능하게 합니다. 이 승인은 파일에 대한 서신을 통해 이루어진 수정 및 개선 사항과 관련이 있으며, iRhythm의 품질, 규정 준수 및 성능에 대한 헌신을 보여줍니다.
CEO Quentin Blackford는 이것이 올해 초 제출된 두 개의 510(k) 승인 중 첫 번째라고 밝혔으며, 회사는 곧 두 번째 승인에 대한 소식을 들을 것으로 예상하고 있습니다. 두 제출 모두 FDA와의 지속적인 시정 노력의 일환입니다. iRhythm은 환자 안전, Zio AT의 임상 성능에 대한 의사 신뢰, 서비스 품질 및 규제 준수에 대한 헌신을 지속하고 있습니다.
iRhythm Technologies (NASDAQ:IRTC) a reçu l'approbation 510(k) de la FDA pour les mises à jour de conception précédemment apportées à son dispositif Zio AT. Le Zio AT, avec le logiciel d'utilisation ECG Zio (ZEUS), permet la surveillance de la télémétrie cardiaque mobile ambulatoire (MCT) pour les patients non critiques. Cette approbation est liée à des modifications et améliorations effectuées par lettre à l'appui et démontre l'engagement d'iRhythm envers la qualité, la conformité et la performance.
Le PDG Quentin Blackford a déclaré que ceci est la première de deux approbations 510(k) soumises au début de l'année, l'entreprise s'attendant à recevoir bientôt des nouvelles concernant la seconde. Les deux soumissions font partie des efforts de remédiation en cours avec la FDA. iRhythm reste engagé envers la sécurité des patients, la confiance des médecins dans la performance clinique du Zio AT, la qualité du service et la conformité réglementaire.
iRhythm Technologies (NASDAQ:IRTC) hat die FDA 510(k) Genehmigung für frühere Designaktualisierungen seines Zio AT Geräts erhalten. Das Zio AT, zusammen mit der Zio ECG-Nutzungssoftware (ZEUS), ermöglicht ambulante Mobile Cardiac Telemetry (MCT) Überwachung für nicht kritische Patienten. Diese Genehmigung bezieht sich auf Änderungen und Verbesserungen, die per Schreiben zu den Akten gemacht wurden, und zeigt iRhythms Engagement für Qualität, Compliance und Leistung.
CEO Quentin Blackford erklärte, dass dies die erste von zwei 510(k) Genehmigungen ist, die zu Beginn des Jahres eingereicht wurden, wobei das Unternehmen erwartet, bald von der zweiten zu hören. Beide Einreichungen sind Teil der laufenden Abhilfemaßnahmen mit der FDA. iRhythm bleibt dem Patientenschutz, dem Vertrauens der Ärzte in die klinische Leistung des Zio AT, der Servicequalität und der regulatorischen Compliance verpflichtet.
- FDA 510(k) clearance received for Zio AT device design updates
- Zio AT remains commercially available in the US market
- First of two 510(k) clearances obtained as part of FDA remediation efforts
- Ongoing remediation efforts with FDA indicate previous regulatory issues
Insights
The FDA's 510(k) clearance for iRhythm's Zio AT device design updates is a positive development for the company. This clearance validates previously made modifications, demonstrating iRhythm's commitment to regulatory compliance and product quality. It's important to note that:
- Zio AT remains commercially available in the U.S. market
- This is the first of two 510(k) submissions related to FDA remediation efforts
- The company expects a decision on the second 510(k) soon
For investors, this clearance reduces regulatory risk and reinforces iRhythm's position in the ambulatory cardiac monitoring market. However, the full impact will depend on the outcome of the second pending 510(k) submission.
iRhythm's Zio AT device plays a important role in the company's product portfolio for ambulatory Mobile Cardiac Telemetry (MCT) monitoring. The FDA clearance strengthens iRhythm's market position:
- Enhances credibility with healthcare providers and patients
- Potentially expands market share in the
$2 billion U.S. ambulatory cardiac monitoring market - Supports iRhythm's competitive edge against rivals like BioTelemetry and Preventice Solutions
While this news is positive, investors should monitor the company's revenue growth, market share gains and the outcome of the second 510(k) submission to fully assess the long-term impact on iRhythm's financial performance.
Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) monitoring service for non-critical care patients
SAN FRANCISCO, Oct. 21, 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 the U.S. Food and Drug Administration (FDA) has granted clearance for its 510(k) submission related to prior design changes made to the Zio AT device via letter to file. Zio AT remains commercially available on the market to ship to customers in the United States.
“This clearance is related to modifications and certain enhancements to our Zio AT device previously made via letter to file and has been a priority for our teams to demonstrate iRhythm’s commitment to quality, compliance and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k)s at the beginning of this year, and we look forward to hearing about our second 510(k) in the near future. Both 510(k) submissions are related to our ongoing remediation efforts with the FDA, and we remain committed to patient safety, physician trust in Zio AT’s clinical performance, service quality, and regulatory compliance.”
About the Zio AT System
The Zio AT device is a prescription-only outpatient cardiac telemetry device, commonly referred to as a mobile cardiac telemetry device, which is used for the provision of our mobile cardiac telemetry (MCT) services. The Zio AT system consists of: the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days; the wireless gateway that provides connectivity between the Zio AT patch and the Zio ECG Utilization Software (ZEUS) to transmit data during the wear period; and ZEUS, iRhythm’s deep-learning algorithm that analyzes cardiac events transmitted by the Zio AT device and gateway. The Zio AT services provide event transmission reports during wear and a comprehensive end-of-wear report1-4 with preliminary findings to the treating medical professional for final clinical decisions. The Zio AT services are provided by iRhythm’s independent diagnostic testing facilities located in San Francisco, California, Deerfield, Illinois and Houston, Texas.
Zio Services’ Clinically Proven Performance
The value of the Zio service has been demonstrated in over 100 original scientific research manuscripts5. Zio AT’s patient-centered design enables high patient compliance and analyzable time with minimal noise or artifact6-8, and real-world data shows an impressive
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.
Zio AT Indications For Use
The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or 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. It is not intended for use on critical care patients.
Contraindications
- Do not use the Zio AT device for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient or when real-time or in-patient monitoring should be prescribed.
- Do not use the Zio AT device for patients with known history of life-threatening arrhythmias.
- Do not use the Zio AT device in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI.
- Do not use the Zio AT device on patients with a neuro-stimulator, as it may disrupt the quality of ECG data.
- Do not use the Zio AT device on patients who do not have the competency to wear the device for the prescribed monitoring period.
Investor Contact
Stephanie Zhadkevich
investors@irhythmtech.com
Media Contact
Kassandra Perry
irhythm@highwirepr.com
- Zio AT Clinical Reference Manual. iRhythm Technologies, 2022.
- Continuous, uninterrupted refers to the recording of ECG data. Zio AT Gateway transmissions may be impacted by a variety of factors. See Product Labeling for more information.
- Zio AT is contraindicated for critical care patients.
- Do not use Zio AT for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient or when real-time or in-patient monitoring should be prescribed. Refer to the Zio AT labeling and Clinical Reference Manual for full contraindications.
- Data on file. iRhythm Technologies, 2023.
- Data on file. iRhythm Technologies, 2022-2023.
- Zio XT Clinical Reference Manual. iRhythm Technologies, 2019.
- Zio monitor Instructions for Use. iRhythm Technologies, 2023.
- Zio AT Clinical Reference Manual. iRhythm Technologies, 2022.
- Data on file. iRhythm Technologies, 2021-2022.
- Based on a review of all online Zio XT, Zio monitor, and Zio AT end-of-wear reports. Data on file. iRhythm Technologies, 2023.
FAQ
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