Study Watch
Verily Life Sciences LLCThe Study Watch by Verily Life Sciences LLC is a wearable ECG monitoring device that records and securely transmits single-channel ECG waveforms. It assists healthcare professionals in tracking heart rhythms of adult patients with known or suspected heart conditions by enabling remote ECG data collection and review via a web portal.
Intended Use
The Study Watch is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms for use by healthcare professionals, adult patients with known or suspected heart conditions, and health conscious individuals.
Technology
The device is a miniaturized physiological data monitoring system with a band and proprietary watch incorporating two dedicated sensing electrodes to obtain single-channel ECG measurements. It securely transfers ECG data to a cloud server via a cradle and Study Hub device for healthcare professionals to view through a web portal.
Performance
Clinical performance testing demonstrated the Study Watch produces accurate ECG waveform data with qualitative equivalence to a predicate device. Non-clinical testing confirmed software stability, sensor performance, and device safety. Testing supports safety, effectiveness, and substantial equivalence.
Predicate Devices
No predicate devices specified
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