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 98% patient compliance9, in part thanks to Zio AT’s zero required patient manipulations. Furthermore, physicians agree with the Zio service's comprehensive end-of-wear report 99% of the time10-11.
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
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