iRhythm Technologies Receives FDA 510(k) Clearance for Design Updates Previously Made to Its Zio? AT Device
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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 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.