Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Verily Life Sciences LLCThe Study Watch with Irregular Pulse Monitor by Verily Life Sciences is a wearable device designed for adults diagnosed with or at risk for atrial fibrillation (AF). It continuously monitors heart rhythms using photoplethysmography (PPG) and single-channel ECG measurements. The device notifies users of irregular pulses, prompting ECG collection, and securely transmits data for healthcare provider review. This aids early detection and monitoring of AF, enabling timely clinical intervention.
Intended Use
Indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. It is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The device is intended for prescription use only.
Technology
The device is a miniaturized wearable watch incorporating two dedicated sensing electrodes for single-channel ECG and an optical sensor for PPG waveform collection. It uses a proprietary algorithm developed via machine learning to analyze continuous PPG data, detecting irregular pulses every 15 minutes during patient wear. ECG rhythms collected are securely transferred via proprietary Study Hub or Watch App to a cloud server for healthcare provider review through a web portal. The portal allows viewing of time-stamped ECG waveforms but no analysis. The device is interoperable with ZEUS System (Zio Watch) software.
Performance
Performance testing included bench verification and validation of software and hardware components against specifications, all meeting acceptance criteria. Clinical validation involved a prospective study collecting free-living PPG data from patients at risk of AF, with simultaneous reference ECG using Zio Patch. The device showed high sensitivity (96.1%) and specificity (98.1%) in detecting irregular pulse indicating atrial fibrillation, exceeding pre-specified thresholds and demonstrating equivalence to the predicate device (K192415) in safety and effectiveness for home use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/12/2021
9 months - 2
FDA Approval
7/19/2022
Other devices from Verily Life Sciences LLC
- Study Watch with Irregular Pulse Monitor2020 • 510K
- Study Watch2019 • 510K
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