FDA Clears iRhythm's ZEUS System For Zio Watch Made In Partnership With Google's Verily

iRhythm Technologies Inc IRTC has received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch.
Produced in partnership with Verily, an Alphabet Inc GOOG precision health company, the ZEUS System combines deep algorithms with a proven and trusted cardiac arrhythmia service.
The ZEUS System is the AI algorithm and solution component of the Zio Watch: a sensor-based wearable for a noninvasive, clinical grade, long-term continuous monitoring for atrial fibrillation (AFib).
Verily also received FDA 510(k) clearance for the Zio Watch (Study Watch with Irregular Pulse Monitor).
The Zio Watch with the ZEUS System is an integrated, prescription-based solution that addresses clinician workflows, care pathways, and the patient experience.
The cleared Zio Watch is a wrist-worn solution that not only detects AFib but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis.
The Zio Watch uses continuous photoplethysmography (PPG), an AI-based algorithm, to detect AFib and calculate an AFib burden estimate.
Findings from the Verily Study: Watch AFib Detection At Home show that interval-level sensitivity and specificity of the AFib Context Engine algorithm within the ZEUS System were 93.6% and 99.1%, respectively.
The Zio Watch and the ZEUS System are not yet commercially available, and iRhythm will continue to build clinical research going into 2023.