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
Device Timeline
- 1
Submission
9/7/2018
4 months - 2
FDA Approval
1/17/2019
Other devices from Verily Life Sciences LLC
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.