iRhythm Technologies Receives FDA 510(k) Clearance for Design Modifications to Its Zio® AT Device
iRhythm Technologies (NASDAQ:IRTC) has received FDA 510(k) clearance for design modifications and labeling updates to its Zio AT device, which provides ambulatory Mobile Cardiac Telemetry (MCT) monitoring for non-critical care patients. The enhancements, addressing concerns noted in a 2023 FDA warning letter, will be available in 2025. The Zio AT device, used in conjunction with the Zio ECG Utilization Software (ZEUS), remains commercially available in the United States while the approved modifications are implemented.
iRhythm Technologies (NASDAQ:IRTC) ha ricevuto l'autorizzazione FDA 510(k) per modifiche al design e aggiornamenti dell'etichettatura del suo dispositivo Zio AT, che fornisce monitoraggio di Telemetria Cardiaca Mobile (MCT) ambulatoriale per pazienti non critici. I miglioramenti, che affrontano le preoccupazioni evidenziate in una lettera di avvertimento della FDA del 2023, saranno disponibili nel 2025. Il dispositivo Zio AT, utilizzato insieme al Software di Utilizzo ECG Zio (ZEUS), rimane commercialmente disponibile negli Stati Uniti mentre vengono implementate le modifiche approvate.
iRhythm Technologies (NASDAQ:IRTC) ha recibido la autorización 510(k) de la FDA para las modificaciones de diseño y las actualizaciones de etiquetado de su dispositivo Zio AT, que proporciona monitoreo ambulatorio de Telemetría Cardiaca Móvil (MCT) para pacientes no críticos. Las mejoras, que abordan las preocupaciones mencionadas en una carta de advertencia de la FDA de 2023, estarán disponibles en 2025. El dispositivo Zio AT, utilizado junto con el Software de Utilización de ECG Zio (ZEUS), sigue estando comercialmente disponible en los Estados Unidos mientras se implementan las modificaciones aprobadas.
iRhythm Technologies (NASDAQ:IRTC)는 비슷입원 환자를 위한 이동 심장 모니터링(MCT)을 제공하는 Zio AT 장치의 디자인 수정 및 라벨 업데이트에 대해 FDA 510(k) 승인을 받았습니다. 2023년 FDA 경고 편지에서 언급된 우려 사항을 처리한 이 개선 사항은 2025년에 제공될 예정입니다. Zio ECG 활용 소프트웨어(ZEUS)와 함께 사용되는 Zio AT 장치는 승인된 수정 사항이 구현되는 동안 미국에서 계속 상용화됩니다.
iRhythm Technologies (NASDAQ:IRTC) a reçu l'autorisation FDA 510(k) pour des modifications de conception et des mises à jour d'étiquetage de son dispositif Zio AT, qui fournit une surveillance de la Télémétrie Cardiaque Mobile (MCT) ambulatoire pour les patients non critiques. Les améliorations, qui répondent aux préoccupations évoquées dans une lettre d'avertissement de la FDA en 2023, seront disponibles en 2025. Le dispositif Zio AT, utilisé en conjonction avec le Logiciel d'Utilisation ECG Zio (ZEUS), reste commercialement disponible aux États-Unis pendant la mise en œuvre des modifications approuvées.
iRhythm Technologies (NASDAQ:IRTC) hat die FDA 510(k)-Zulassung für Designänderungen und Aktualisierungen der Kennzeichnung seines Zio AT-Geräts erhalten, das mobile kardiale Telemetrie (MCT)-Überwachung für nicht kritische Patienten bietet. Die Verbesserungen, die Bedenken ansprechen, die in einem Warnschreiben der FDA aus dem Jahr 2023 genannt wurden, werden 2025 verfügbar sein. Das Zio AT-Gerät, das in Kombination mit der Zio ECG-Nutzungssoftware (ZEUS) verwendet wird, bleibt während der Umsetzung der genehmigten Änderungen kommerziell in den Vereinigten Staaten verfügbar.
- FDA 510(k) clearance obtained for Zio AT device modifications
- Product remains commercially available in US market during enhancement implementation
- Addresses regulatory compliance issues from 2023 FDA warning letter
- Enhanced features won't be available until 2025
- Previous FDA warning letter indicates past compliance issues
Insights
The FDA 510(k) clearance for Zio AT device modifications represents a significant regulatory milestone for iRhythm, addressing previous compliance concerns from a 2023 warning letter. The enhancements focus on design features and labeling updates for their Mobile Cardiac Telemetry monitoring service, demonstrating the company's commitment to regulatory compliance and product improvement.
While this clearance is positive for long-term business prospects, the delayed implementation until 2025 suggests a measured impact on near-term revenue. The modifications appear to be more about maintaining regulatory compliance than introducing revolutionary features, though they should help solidify the company's market position in cardiac monitoring.
The clearance reduces regulatory risk and strengthens iRhythm's competitive position in the
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
FDA 510(k)-cleared enhancements will be available in 2025
SAN FRANCISCO, Oct. 30, 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 design modifications and labeling updates for the Zio AT device. Zio AT remains commercially available on the market to ship to customers in the United States, and product enhancements subject to this 510(k) clearance will be available in 2025.
“This clearance is related to enhancements to our Zio AT product, including design features and labeling updates intended to address areas of concern specific to Zio AT that were noted in a 2023 FDA warning letter to the Company,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We believe these features that were subject to this clearance advance our technology for the benefit of patients, physicians, and healthcare systems who rely on our Zio AT services. At all times, 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 patch 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 heartbeats12 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.
- Based on the US and UK data using Zio ECG monitors. Data on file. iRhythm Technologies, 2023.
FAQ
What FDA clearance did iRhythm Technologies (IRTC) receive in October 2023?
When will the FDA-cleared enhancements to iRhythm's (IRTC) Zio AT device be available?
What issues does the new FDA clearance for iRhythm's (IRTC) Zio AT address?
