iRhythm Technologies Gains FDA Clearance for Zio Design Changes

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to design modifications and labeling updates to iRhythm Technologies Inc.’s Zio AT device.

AT is still commercially available to U.S. customers but product enhancements subject to this 510(k) clearance will not be available until next year.

“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,” iRhythm President/CEO Quentin Blackford said. “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.”

Zio AT is a prescription-only outpatient cardiac telemetry product, commonly referred to as a mobile cardiac telemetry device, which is used for the provision of iRhythm Technologies’ 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; a 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^1-4 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; Deerfield, Ill.; and Houston, Texas.

Zio’s service value has been proven in more than 100 original scientific research manuscripts.⁵ Zio AT’s patient-centered design enables high patient compliance and analyzable time with minimal noise or artifact,^6-8 and real-world data shows a 98% patient compliance,⁹ in part thanks to Zio AT’s zero required patient manipulations. Physicians also agree with the Zio service’s comprehensive end-of-wear report 99% of the time.^10-11

iRhythm is a digital health care company that creates 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.

References
¹ Zio AT Clinical Reference Manual. iRhythm Technologies, 2022.
² 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.
³ Zio AT is contraindicated for critical care patients.
⁴ 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.
⁵ Data on file. iRhythm Technologies, 2023.
⁶ Data on file. iRhythm Technologies, 2022-2023.
⁷ Zio XT Clinical Reference Manual. iRhythm Technologies, 2019.
⁸ Zio monitor Instructions for Use. iRhythm Technologies, 2023.
⁹ Zio AT Clinical Reference Manual. iRhythm Technologies, 2022.
¹⁰ Data on file. iRhythm Technologies, 2021-2022.
¹¹ Based on a review of all online Zio XT, Zio monitor, and Zio AT end-of-wear reports. Data on file. iRhythm Technologies, 2023.
¹² Based on the US and UK data using Zio ECG monitors. Data on file. iRhythm Technologies, 2023.