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July 25, 2022

US FDA grants 510(k) clearance for iRhythm Technologies’ ZEUS system

The ZEUS System will become the AI algorithm and solution component for the Zio Watch sensor-based wearable device.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for iRhythm Technologies’ clinically integrated Zio ECG Utilization Software (ZEUS) System.

iRhythm has developed the ZEUS System in collaboration with Verily, Alphabet’s precision health company, for the Zio Watch, which is an FDA 510(k) cleared study watch with an irregular pulse monitor.

Zio Watch has been designed for clinical-grade, non-invasive, long-term continuous monitoring of atrial fibrillation (AFib).

The ZEUS System combines deep-learned algorithms and cardiac arrhythmia services to provide an artificial intelligence (AI) algorithm and solution component for the sensor-based, wearable Zio Watch device.

The wrist-worn device detects AFib and determines the amount of AFib over time, helping clinicians with diagnosis.

Using a continuous photoplethysmography (PPG), AI-based algorithm, the device detects AFib and calculates an AFib burden estimate.

The Zio Watch then sends a preliminary report for clinician review. This will potentially help in diagnosis and clinical intervention.

Together with the ZEUS System, Zio Watch is an integrated, prescription-based device that is designed to improve clinician workflows, patient experience and care pathways.

iRhythm CEO and president Quentin Blackford said: “We are incredibly excited about this important milestone as we make progress in bringing a new monitoring platform to patients who can benefit from it.

“There is a clear need in the market today for a clinical grade, long-term and non-invasive monitoring solution.

“iRhythm is focused on redefining the standard of care with earlier insight to predict and prevent disease, and the Zio Watch with ZEUS System provides clinicians a platform that has the potential to meaningfully improve patients’ lives.”

The company noted that the Zio Watch and ZEUS System are not yet commercially available. A limited market evaluation of the ZEUS System is planned for next year.

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