The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for design modifications and labeling updates to iRhythm Technologies Inc.’s Zio AT device, which is still available to U.S. customers. However, the enhancements covered by this clearance will not be implemented until next year.
Quentin Blackford, President and CEO of iRhythm, noted that the clearance addresses specific concerns raised in a 2023 FDA warning letter. The improvements aim to enhance the device’s technology for the benefit of patients, physicians, and healthcare systems. The Zio AT is a prescription-only mobile cardiac telemetry device that monitors ECG data for up to 14 days. It comprises the Zio AT patch, a wireless gateway for data transmission, and ZEUS, a deep-learning algorithm for cardiac event analysis.
iRhythm emphasizes the high patient compliance of the Zio AT device, which has been proven in over 100 research studies. The design encourages patient adherence with minimal interference, boasting a 98% compliance rate. Additionally, physicians agree with the service’s comprehensive end-of-wear report 99% of the time.
As a digital healthcare company, iRhythm combines wearable biosensors with cloud-based analytics to provide clinically actionable insights, aiming to improve patient care and health outcomes.
The FDA’s 510(k) clearance for iRhythm Technologies Inc.’s Zio AT device marks a significant step forward in enhancing cardiac monitoring technology. Addressing concerns from a previous warning letter, the planned design modifications and labeling updates aim to benefit patients and healthcare providers alike. The Zio AT, known for its high patient compliance rate of 98%, enables ECG data monitoring for up to 14 days, leveraging a combination of a patch, wireless gateway, and deep-learning algorithms for event analysis. With over 100 research studies backing its efficacy, iRhythm continues to advance digital healthcare through innovative wearable biosensors and cloud-based analytics, ultimately enhancing patient care and health outcomes.