Zio Watch and Paired Software System Earn FDA Nod for AFib Detection

Alphabet subsidiary Verily and cardiac monitor maker iRhythm Technologies have been granted the FDA’s 510(k) clearance for a new system for convenient monitoring of cardiac arrhythmia. The agency’s sanction pertains to both the Zio ECG Utilization Software System, called Zeus—an AI algorithm that monitors cardiac arrhythmia; and the smart wearable Zio Watch, which was developed by Verily and iRhythm. The partner companies, which have been collaborating in this space since 2019, hope to hone the watch for long-term continuous monitoring of atrial fibrillation; it and the Zeus system are inching toward commercial availability. iRhythm’s Executive Vice President of Strategy, Corporate Development, and Investor Relations, Daniel Wilson, expects market evaluation to commence in the first months of next year.

Designed to help physicians in diagnostic decision-making, the combined device measures and characterizes AFib activity over time. When enough data is aggregated in detail via the watch, a report is transmitted to the wearer’s clinician for review.

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The Zio Watch has its work cut out in having to punch up to the Apple Watch, a cultural mainstay that has enjoyed a reign at the top of the medtech wearables space for some time as well as FDA clearance for heart rhythm detection since 2018. Zio’s iRhythm-enhanced AI capabilities, however, could make it stand out upon its eventual rollout.