Study Watch with Irregular Pulse Monitor
Verily Life Sciences LLCThe Study Watch with Irregular Pulse Monitor is a wearable device that records, stores, and transmits single-channel ECG rhythms to help detect irregular pulses such as atrial fibrillation in adults. It uses proprietary electrodes and PPG sensors to collect physiological data, which can be reviewed by healthcare professionals via a web portal to support diagnosis and patient monitoring.
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. Intended to record, store, transfer, and display single-channel ECG rhythms in professional healthcare facility environments while worn as a wrist watch.
Technology
Miniaturized physiological data monitoring device including a wearable watch with two dedicated sensing electrodes for ECG measurement and an optical sensor for PPG waveform collection. Data is transferred securely to a cloud server via a cradle and a Study Hub device, and accessed by healthcare providers via a web portal. Uses proprietary hardware and firmware for data acquisition and irregular pulse detection.
Performance
Bench testing validated performance of PPG sensor, battery life, firmware including irregular pulse monitoring feature, following predicate device verification. Human factors studies demonstrated effective use of instructions and user interface. Clinical testing showed sensitivity of 85% and specificity of 96% for irregular pulse detection in patients with atrial fibrillation, meeting pre-specified endpoints and confirming substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/4/2019
4 months - 2
FDA Approval
1/17/2020
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