- iRhythm Technologies Inc (NASDAQ: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 (NASDAQ: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.
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