Study Watch

The Verily Study Watch is an over-the-counter, single-channel ECG device designed for adults to record, store, and transfer their cardiac rhythms for review by healthcare professionals. Utilizing a three-electrode system for enhanced signal quality and a cloud-based platform for data transmission and HCP access, it aims to facilitate remote cardiac monitoring without providing direct patient waveform review or automated analysis.

The Verily Study Watch is a wearable device designed for adult users (22 years or older), including those with known or suspected heart conditions, health-conscious individuals, and for use by healthcare professionals. Its primary function is to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The device is intended for over-the-counter use, allowing individuals to capture their ECG data, which is then made available to healthcare professionals for review. The Study Watch system comprises a miniaturized watch with two sensing electrodes and an additional right leg drive (RLD) electrode to enhance signal quality by reducing electrical interference. Users initiate a 30-second ECG recording via the watch's graphical user interface. While an animated waveform is briefly shown during capture, the patient does not have direct access to the stored waveform. The collected ECG data is transferred from the watch via a charging cradle and the "Study Hub" device to Verily's secure cloud server. Healthcare professionals can then view these time-stamped ECG waveforms through a dedicated web portal, which does not include automated analysis features. Clinical performance data demonstrated qualitative equivalence to a 12-lead ECG, with a Bland-Altman analysis showing minimal bias (-0.3 ms) and narrow limits of agreement (+/- 9.7 ms) for QRS intervals.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the inclusion of the Right Leg Drive (RLD) electrode in the Study Watch specifically improve ECG signal quality compared to similar single-lead devices without it, particularly in ambulatory settings with varying noise levels?; What are the specific data security and privacy measures implemented for the transfer and storage of ECG data from the Study Watch to Verily's cloud server and during access by healthcare professionals via the web portal?; Given that patients do not have direct access to their recorded ECG waveforms, what is the recommended protocol for patient feedback or engagement regarding their collected data, and how might this impact patient adherence or understanding?; What is the typical battery life of the Study Watch under conditions of frequent (e.g., multiple daily) ECG recordings, and what is the data storage capacity on the watch itself before requiring transfer via the Study Hub?; While the current web portal is for viewing only, are there future development plans to incorporate analytical tools or automated preliminary screening features for healthcare professionals, and how would these be validated?