Study Watch

by Verily Life Sciences  · Based in United States →Powering AI-enabled precision health solutions that accelerate research and improve care for individuals and communities.
Cardiology Neurology Sleep Medicine

Not publicly available (device for clinical research and partnerships)
Regulatory Status Disclosed

Overview

The Verily Study Watch is a sensor-based wearable device designed for non-invasive, continuous physiological monitoring, primarily utilized in clinical research and observational studies. It is a prescription-only device. The watch features multiple physiological sensors capable of collecting biometric health information, including electrocardiogram (ECG), heart rate, electrodermal activity, and inertial movements. Data captured by the Study Watch is encrypted before being uploaded and processed in Verily’s secure cloud platform, leveraging proprietary algorithms and machine learning tools for analysis. Engineered for long-term data collection with minimal interruption, it boasts a battery life of up to one week and incorporates an e-ink display for power efficiency. The device is intended for use by healthcare professionals and adult patients (22 years or older) with known or suspected heart conditions, as well as health-conscious individuals participating in research.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Continuous physiological monitoring
  • Multiple physiological sensors (ECG, heart rate, electrodermal activity, inertial movements)
  • Long battery life (up to one week)
  • Internal data storage and encryption
  • Cloud-based data processing with algorithms and machine learning
  • On-demand single-channel ECG
  • Irregular pulse monitor
  • E-ink display for minimal power consumption
  • Designed for clinical research, not consumers
  • Objective measures for sleep behavior, walking behavior, cardiac measures, and motor function

Use Cases

  • Clinical trials and observational studies
  • Parkinson's disease monitoring (tremors, gait, motor fluctuations, disease progression)
  • Cardiovascular health research (irregular heart rhythms, atrial fibrillation screening, diagnosis, and management)
  • Baseline Study (gathering fundamental dataset of human health)
  • Sleep and stress monitoring in mental health research
  • Ambulatory status and physical activity monitoring

What Physicians Need to Know

ECG/EKG Analysis Capability
The Verily Study Watch has received FDA 510(k) clearance for its on-demand ECG feature, enabling it to record, store, transfer, and display single-channel ECG rhythms. It utilizes two dedicated sensing electrodes for ECG measurement. The collected ECG data is securely transferred to a cloud server for review by healthcare professionals via a web portal, rather than being directly accessible to the patient.
Arrhythmia Detection Accuracy
The Study Watch, with its Irregular Pulse Monitor feature, is designed for continuous monitoring and detection of atrial fibrillation (AFib) using photoplethysmography (PPG) and prompts for a confirmatory single-lead ECG if AFib is suspected. Clinical studies have confirmed its accuracy in detecting AFib episodes, demonstrating an interval-level sensitivity of 96.1% and specificity of 98.1% for AF detection with its PPG-based algorithm.
Heart Failure Risk Prediction
Recent research indicates the Verily Study Watch's potential in identifying patients at risk for heart failure. A study utilizing digital walking measures captured by the watch found significant associations with varying levels of heart failure risk in asymptomatic individuals or those predisposed to the condition, with these measures correlating with in-clinic physical functioning tests.
Cardiac Monitoring Integration
The Study Watch is a prescription-only device intended for unobtrusive biosensing and continuous physiological data collection in clinical research, including heart rate and ECG. Data is securely uploaded and processed in the cloud using Verily's backend algorithms and machine learning tools, accessible to healthcare providers via a web portal. It integrates with iRhythm's Zio Service for enhanced continuous AFib monitoring, data analytics, and cloud-based machine learning.
AHA/ACC Guideline Alignment
While Verily's focus on cardiovascular health aligns with the American Heart Association's (AHA) goal of advancing mobile health for prevention and care, the Study Watch's primary role is as an FDA-cleared device for ECG recording and irregular pulse monitoring in clinical research settings, supporting data collection for clinicians.
Real-Time Alert Capability
The device features a real-time alert system that prompts the wearer to take a single-lead ECG if its photoplethysmography (PPG) readings suggest atrial fibrillation. The results are then analyzed by a cardiographic technician before being shared with the patient's physician.
Physician Tip

The Verily Study Watch is a prescription-only, clinical-grade wearable primarily designed for research and long-term physiological data collection. Physicians should leverage its FDA-cleared single-channel ECG and irregular pulse (AFib) detection capabilities for monitoring patients with known or suspected heart conditions. The device's ability to capture continuous data, including digital walking measures, can provide valuable insights for heart failure risk stratification and complement traditional in-clinic assessments. Emphasize that raw ECG data is for HCP review via a secure portal, not direct patient interpretation, ensuring clinical oversight.

The Verily Study Watch integrates with Verily's secure cloud-based platform for data transfer and processing, utilizing backend algorithms and machine learning. A key integration is with iRhythm Technologies' Zio Service, which provides continuous AFib monitoring, advanced data analytics, and AI-based arrhythmia diagnosis, aiming to streamline screening, diagnosis, and management of AFib. This collaborative approach enhances the clinical utility of the collected data.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Not publicly available (device for clinical research and partnerships) N/A
DeploymentCloud (data uploaded from device to Verily's cloud platform).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Verily Study Watch received 510(k) clearance from the FDA as a Class II medical device for its on-demand electrocardiogram (ECG) feature (K182456, cleared January 17, 2019). It also received a new 510(k) clearance for an irregular pulse monitor feature (January 2020). It is a prescription-only device intended to record, store, transfer, and display single-channel ECG rhythms.

Integrations
EHR Not specified
Specialties Cardiology, Neurology, Sleep Medicine

What the Web Says

The Verily Study Watch is a prescription-only, investigational wearable device designed for clinical research and continuous monitoring of physiological data. It has received FDA 510(k) clearance for its ECG feature and for continuous monitoring of atrial fibrillation (AFib). The watch is primarily intended for researchers to collect rich, complex datasets in clinical and observational studies, rather than for direct consumer use.

Overall: Mixed

Strengths

  • Collects high-resolution physiological data unobtrusively.
  • Long battery life (up to one week) and large storage capacity for raw data.
  • Designed for research-grade data collection with a focus on security and encrypted data upload.
  • FDA cleared for ECG and continuous AFib monitoring.
  • Potential to provide long-term data on sleep patterns, heart variability, and activity for various health conditions.
  • Can be upgraded over-the-air to accommodate new technology and extensions.

Limitations

  • Data is primarily for researchers; participants do not have direct access to their collected data.
  • Not available for general sale; it is an investigational device.
  • FDA rejected a bid to add a Parkinson's disease exam tool due to concerns about interpreting meaningful changes in patient function.
  • Performance of PPG-based algorithm for AFib detection was modestly affected by vigorous activity and had a slight decrease in performance among individuals with darker skin tones.
  • Some Reddit discussions indicate a perception of Verily as chaotic or not investing enough in certain initiatives.
  • Sleep stage classification accuracy varies, with light sleep having the lowest accuracy.

Based on reviews from: Med Device Online, Fierce Biotech, Performance of the Verily Study Watch for measuring sleep compared to polysomnography, accessdata.fda.gov, Forbes, Smartwatch Could Reduce Fallout From False-Positive AFib Readouts, Reddit, Medthority, BioWorld, Australian Academy of Technological Sciences & Engineering, Thinkers 50, ResearchGate, FINDIT u5e73u53f0, Physician Ai Tools, Bioinformatics Tools and Big Data Analytics For Patient Care-CRC Press (2022) | PDF | Proteomics - Scribd, SlashGear

Last updated: 2026-07-19

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Press & Coverage

Verily Blog
Verily Study Watch Receives FDA 510(k) Clearance for ECG
Verily announced that its Study Watch received FDA 510(k) clearance as a Class II medical device for its on-demand ECG feature, intended for prescription-only use by healthcare professionals and patients with known or suspected heart conditions. This clearance allows the watch to record, store, transfer, and display single-channel ECG rhythms for both research and clinical care.
2019-01
HCPLive
FDA Approves ECG Device, Verily Study Watch | HCPLive
The FDA granted 510(k) clearance to Verily's Study Watch, classifying it as a Class II medical device for its on-demand ECG feature, which records, stores, transfers, and displays single-channel ECG rhythms. The prescription-only device is intended for healthcare professionals, adult patients with known or suspected heart conditions, and health-conscious individuals.
2019-01
MD+DI Online
Verily Powers up Position in Wearables with New FDA Nod
Verily's Study Watch received a new FDA clearance to measure irregular heartbeats, building on its initial ECG clearance from the previous year. This development supports Verily's collaboration with iRhythm to improve screening, diagnosis, and management of atrial fibrillation (AFib).
2020-01
Becker's Hospital Review
Verily receives FDA clearance for arrhythmia monitoring wearable - Becker's Hospital Review | Healthcare News & Analysis
Alphabet's life sciences subsidiary Verily received 510(k) clearance from the FDA for a feature enabling irregular pulse detection by its Study Watch wearable device. This clearance expands the device's health monitoring capabilities, following its initial clearance for an on-demand electrocardiogram feature.
2020-01
FierceBiotech
Verily moves further into heart research as Study Watch picks up new FDA clearance
Verily's Study Watch received FDA 510(k) clearance for an irregular pulse monitor feature, which the company plans to leverage in building solutions for screening, diagnosis, and management of atrial fibrillation. This new capability will be integrated into Verily's cardiovascular programs, including its collaboration with iRhythm.
2020-01
FierceBiotech
Verily advances smartwatch toward Parkinson's clinical trial use after validating technology
Researchers have published evidence validating Verily's Study Watch for recording measurements that may serve as digital biomarkers for Parkinson's disease progression, potentially reducing the sample size needed for therapeutic intervention studies. The study highlighted the value of remote testing for a more complete picture of disease severity.
2022-05
Verily Blog
Study Watch u2013 Another step closer to powering precision health | Verily
Verily announced the publication of data demonstrating the analytical validity of an ambulatory status algorithm from the Study Watch, confirming its ability to reliably detect walking activity in daily life across diverse research populations. This validates the use of the device in real-world settings for measuring physical activity.
2023-03
Michigan Medicine Health Lab
Clinical smart watch finds success at identifying atrial fibrillation | Michigan Medicine
A Michigan Medicine research team developed the Verily Study Watch, a prescription wristwatch that continuously monitors heart rhythm and uses a unique algorithm to accurately detect atrial fibrillation, with results published in the Journal of the American Heart Association. This clinical-grade device aims to address the challenge of false alarms from consumer smartwatches.
2023-11

Videos

Product demos, reviews, and walkthroughs for Study Watch.

View all on YouTube

Frequently Asked Questions

The Verily Study Watch is primarily designed for clinical research to collect real-world data for conditions like cardiovascular health and Parkinson's disease, rather than direct integration into routine clinical practice for individual patient monitoring. Its AI/ML capabilities are used to process and analyze the collected biosensing data, aiming to provide insights into disease progression and daily symptoms for research purposes.
The Verily Study Watch has received FDA 510(k) clearance as a Class II medical device for its on-demand ECG feature and irregular pulse monitor, making it a prescription-only device. All data stored on the watch are encrypted before being uploaded and processed in the cloud, addressing data privacy concerns.
While the Study Watch records and transfers single-channel ECG rhythms, its initial FDA clearance did not include analysis features for detecting atrial fibrillation or normal sinus rhythm on the device itself. Additionally, in some research contexts, it may not accurately measure non-motor symptoms for conditions like Parkinson's disease. Patient compliance with wearing the device can also decrease over time, potentially affecting data continuity.
Unlike many consumer smartwatches, the Verily Study Watch is a prescription-only, clinical-grade device primarily for research, though other smartwatches like Apple Watch and Samsung Galaxy Watch also have FDA-cleared ECG features and irregular rhythm notifications. While consumer wearables are increasingly accurate for heart rate and AFib detection, medical-grade devices like insertable cardiac monitors may offer superior continuous monitoring and detect more AFib episodes, especially nocturnal ones.
The Verily Study Watch is not available for commercial sale to individual consumers or directly to physicians for general clinical use. It is primarily made available to participants in observational studies and clinical trials conducted by Verily and its partners. Therefore, a direct pricing model for physicians to acquire it for routine patient care is not applicable.
For ECG data, the Study Watch records, stores, transfers, and displays single-channel ECG waveforms, which are then sent to the healthcare provider for review. The patient does not have direct access to independently view these data on the device. This indicates that significant clinical interpretation by the physician is still required, as the device itself does not provide diagnostic analysis.
Patients using the Study Watch do not have direct access to independently view their ECG data on the device; this information is recorded and transferred to their healthcare provider. This design choice means the device is intended to augment physician-led care and research, rather than empowering direct patient self-diagnosis or interpretation, which could streamline workflow by reducing false positives seen with consumer devices.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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