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iRhythm Technologies Gains FDA Clearance for Zio AT Device Modifications

• iRhythm Technologies secured FDA 510(k) clearance for design modifications and labeling updates to its Zio AT device, used for mobile cardiac telemetry. • The enhancements address concerns raised in a 2023 FDA warning letter and are slated for implementation in 2025. • The Zio AT device, paired with Zio ECG Utilization Software (ZEUS), remains commercially available in the U.S. during the modification period. • This clearance underscores iRhythm's commitment to regulatory compliance and strengthens its position in the cardiac monitoring market.

iRhythm Technologies, Inc. (NASDAQ:IRTC) has received FDA 510(k) clearance for design modifications and labeling updates to its Zio AT device, a mobile cardiac telemetry (MCT) monitoring system for non-critical care patients. The FDA's decision, announced on October 30, 2024, addresses concerns outlined in a 2023 warning letter from the agency.
The approved enhancements will be integrated into the Zio AT device by 2025. In the meantime, the Zio AT device, used in conjunction with the Zio ECG Utilization Software (ZEUS), will continue to be commercially available in the United States.

Addressing Regulatory Concerns

The modifications to the Zio AT device are intended to resolve specific issues highlighted in the FDA's 2023 warning letter. According to iRhythm, the updates focus on design features and labeling to enhance the device's performance and safety.
Quentin Blackford, iRhythm President and Chief Executive Officer, stated, "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."

Zio AT System Overview

The Zio AT system is a prescription-only outpatient cardiac telemetry device used for mobile cardiac telemetry (MCT) services. It comprises 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 report with preliminary findings to the treating medical professional for final clinical decisions.

Clinical Validation and Performance

The Zio service's clinical value is supported by over 100 original scientific research manuscripts. Studies have demonstrated high patient compliance (98%) and analyzable time with minimal noise or artifact, attributed to the device's patient-centered design and the absence of required patient manipulations. Furthermore, physicians reportedly agree with the Zio service's comprehensive end-of-wear report 99% of the time.

Market Impact and Future Outlook

The FDA clearance is a significant milestone for iRhythm, mitigating regulatory risks and reinforcing its competitive standing in the cardiac monitoring market, estimated at $2.4 billion. While the enhancements will not be available until 2025, this approval demonstrates iRhythm's commitment to regulatory compliance and continuous product improvement.
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Reference News

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iRhythm Technologies Receives FDA 510(k) Clearance for Design Modifications to Its Zio ...
stocktitan.net · Oct 30, 2024

iRhythm Technologies received FDA 510(k) clearance for Zio AT device design modifications and labeling updates, addressi...

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