Study Watch with Irregular Pulse Monitor (Home)

by Verily Life Sciences LLC  · Based in United States → — Making health data useful for healthier, more vibrant lives.
Cardiology Family Medicine Internal Medicine

Contact for pricing
Regulatory Status Disclosed

Overview

The Verily Study Watch with Irregular Pulse Monitor (Home) is a prescription-only wearable device developed by Verily Life Sciences, an Alphabet Inc. company, for use in clinical research and by healthcare professionals. It is designed to unobtrusively collect a wide range of physiological data from participants in real-world settings.

Initially launched as an investigational device in April 2017, the Study Watch has evolved to include advanced monitoring capabilities. It features multiple physiological sensors, such as an on-demand single-channel electrocardiogram (ECG), heart rate tracking, electrodermal activity, and inertial movement sensors. Environmental sensors are also integrated. The device boasts a long battery life of up to one week and substantial internal storage for raw data, which is encrypted on the device for security. Collected data is then uploaded and processed in the cloud using Verily’s proprietary algorithms and machine learning tools.

The Study Watch is not available directly to consumers but is utilized in various clinical studies and by healthcare professionals for specific patient monitoring, particularly in cardiovascular health, neurological conditions, and sleep research.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • On-demand single-channel ECG measurement
  • Irregular pulse monitoring for atrial fibrillation (AFib) detection
  • Multiple physiological sensors (heart rate, electrodermal activity, inertial movements)
  • Environmental sensors
  • Long battery life (up to one week)
  • Large internal data storage with compression
  • On-device data encryption for security
  • Cloud-based data processing with proprietary algorithms and machine learning
  • E-ink display
  • Prescription-only device for clinical and professional use

Use Cases

  • General health data collection in clinical research studies
  • Cardiovascular health research and monitoring, including atrial fibrillation detection
  • Parkinson's disease studies (motor function, disease progression)
  • Sleep pattern monitoring and research
  • Mental health studies (assessing pain, sleep quality, anxiety)
  • Development of digital biomarkers for various conditions

What Physicians Need to Know

ECG/EKG Analysis Capability
The Verily Study Watch offers an on-demand, single-channel electrocardiogram (ECG) feature. It is FDA-cleared to record, store, transfer, and display single-channel ECG rhythms. When an irregular pulse is suspected, the device prompts the user to take a single-lead ECG for confirmation. The collected ECG data is then securely transferred to Verily's cloud server for review by healthcare professionals via a web portal.
Arrhythmia Detection Accuracy
The Study Watch utilizes photoplethysmography (PPG) to continuously monitor heart rhythm and detect subtle changes. Its deep neural network algorithm has demonstrated high accuracy in identifying atrial fibrillation (AFib). In studies, the AFib Context Engine (ACE) algorithm showed interval-level sensitivity of 93.6% and specificity of 99.1%. Another study reported a sensitivity of 96.1% and specificity of 98.1% for AF detection using a PPG-based algorithm. The device can also provide AF burden estimation.
Heart Failure Risk Prediction
Research using the Verily Study Watch has explored the association of digital walking measures with heart failure progression. The walking behavior captured by the watch has been shown to be associated with different levels of Heart Failure (HF) risk in asymptomatic individuals or those at risk of developing HF. Digital measures of walking collected by the wearable sensors could complement traditional clinic-based testing to identify and monitor pre-symptomatic HF.
Cardiac Monitoring Integration
The Study Watch is designed for non-invasive, continuous physiological monitoring. It integrates with Verily's cloud server for data storage and clinician review. Verily has collaborated with iRhythm, integrating the Study Watch with iRhythm's Zio Service to support long-term continuous monitoring, data analytics, and cloud-based machine learning for AFib. There is also a collaboration with Samsung to integrate Galaxy Watch sensor data into Verily's precision health platform, Pre, for clinical research.
AHA/ACC Guideline Alignment
While not explicitly stating direct alignment with specific AHA/ACC treatment guidelines, the Verily Study Watch's focus on cardiovascular health and its FDA clearances for ECG and irregular pulse monitoring align with the American Heart Association's (AHA) goal of advancing mobile health for prevention and care. Studies validating the device's performance are published in reputable journals like the Journal of the American Heart Association.
Real-Time Alert Capability
The Study Watch with Irregular Pulse Monitor is designed to notify the user in the event of an irregular pulse, such as atrial fibrillation, and subsequently recommend an ECG acquisition. This indicates a real-time or near real-time alert mechanism for potential cardiac arrhythmias.
Physician Tip

The Verily Study Watch, a prescription-only device, provides valuable clinical-grade data for monitoring irregular heart rhythms, particularly atrial fibrillation, and can contribute to early identification of heart failure risk through activity monitoring. Its on-demand single-lead ECG and continuous photoplethysmography (PPG) capabilities offer a robust tool for long-term surveillance and burden assessment of AFib. Physicians should leverage the secure cloud data transfer and integration with platforms like iRhythm's Zio Service for comprehensive patient management. While it aids in screening and monitoring, definitive diagnosis and treatment decisions should always be based on a full clinical evaluation.

The Verily Study Watch integrates with Verily's secure cloud infrastructure for data storage and access by healthcare professionals. It has a notable collaboration with iRhythm Technologies, leveraging iRhythm's Zio Service for advanced AFib data analytics and cloud-based machine learning. Additionally, Verily is expanding its integration capabilities through a collaboration with Samsung, aiming to incorporate sensor data from Galaxy Watch devices into its Viewpoint Evidence solution, built on the Verily Pre platform, to accelerate clinical research and generate real-world evidence.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
  • Not publicly available; device is for clinical research and prescription use, not direct consumer sale
DeploymentWearable device with cloud-based data processing.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Verily Study Watch has received multiple 510(k) clearances from the FDA as a Class II medical device. This includes clearance for its on-demand ECG feature (January 2019) and for its irregular pulse monitor feature (January 2020), which is intended to detect irregular heart rhythms such as atrial fibrillation. The K213357 clearance on July 19, 2022, specifically pertains to the 'Study Watch with Irregular Pulse Monitor (Home)', indicating its use for 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. It is a prescription-only device intended to record, store, transfer, and display single-channel ECG rhythms and to notify users of irregular pulse and recommend ECG acquisition.

Integrations
EHR Not specified
Specialties Cardiology, Family Medicine, Internal Medicine

What the Web Says

The Verily Study Watch with Irregular Pulse Monitor (Home) is a prescription-only, clinical-grade wearable designed for adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation (AFib). It continuously monitors heart rhythm using photoplethysmography (PPG) and prompts users to take a single-lead ECG if an irregular pulse is suspected. The device is intended for use in professional healthcare settings and clinical studies, not for direct consumer purchase.

Overall: Positive

Strengths

  • Clinical-grade accuracy for AFib detection, with high sensitivity and specificity.
  • Continuously monitors heart rhythm in a free-living (home use) setting.
  • Integrates with healthcare providers through a cloud-based data network.
  • Aims to reduce false positives seen with consumer-grade smartwatches.
  • Long battery life (week-long) compared to many consumer smartwatches.
  • Can record, store, transfer, and display single-channel ECG rhythms.

Limitations

  • Not available for direct purchase by consumers; prescription-only and intended for clinical use.
  • Performance may decrease for some AFib episodes in participants with darker skin tones, although still able to detect AFib.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra due to its clinical focus and restricted availability.
  • Some consumer smartwatches have shown inaccuracies in detecting AFib.

Based on reviews from: accessdata.fda.gov, Fierce Biotech, Verily Blog, Michigan Medicine, Journal of the American Heart Association, Healthline, ClinicalTrials.gov

Last updated: 2026-07-21

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Study Watch with Irregular Pulse Monitor (Home)

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

accessdata.fda.gov
Study Watch with Irregular Pulse Monitor (Home) 510(k) Clearance
The FDA granted 510(k) clearance to Verily's Study Watch with Irregular Pulse Monitor (Home) on July 19, 2022. This device is intended for prescription use by adults (22 years and older) diagnosed with or susceptible to atrial fibrillation, enabling them to monitor and record heart rhythms.
2022-07
FDA.report
Study Watch with Irregular Pulse Monitor (Home) - FDA.report
This entry details the FDA 510(k) clearance for Verily Life Sciences LLC's Study Watch with Irregular Pulse Monitor (Home) on July 19, 2022, classifying it as a Class II medical device. It is intended for both home and in-clinic use for monitoring irregular pulse.
2022-07
eurekalert.org
Tempus ECG-Low EF vs Study Watch with Irregular Pulse Monitor (Home)
This article compares the Verily Study Watch with Irregular Pulse Monitor (Home) to Tempus ECG-Low EF, highlighting the Study Watch's broader innovation as a comprehensive wearable platform for continuous physiological data collection in clinical research and remote AFib monitoring.
unknown
fdaradiologyai.com
Study Watch with Irregular Pulse Monitor | FDA Radiology AI Device
This page lists the Verily Study Watch with Irregular Pulse Monitor (Home) as an FDA-authorized device, noting its 510(k) clearance in 2022. It also mentions other devices from Verily Life Sciences LLC.
2020-01
ncbi.nlm.nih.gov
FibriCheck detection capabilities for atrial fibrillation (FDAu2013AF): a multicenter validation study
This peer-reviewed study, published in November 2025, includes the Verily Study Watch with Irregular Pulse Monitor (Home) in a comparison of AF detection devices, citing its performance metrics for sensitivity and specificity.
2025-11
fda.gov
TPLC - Total Product Life Cycle - FDA
The FDA's Total Product Life Cycle database lists the Verily Study Watch with Irregular Pulse Monitor (Home) (K213357) among substantially equivalent devices, indicating its regulatory status.
2026-06
hari.io
HaRi u00b7 DXH u2014 Transmitters And Receivers, Electrocardiograph ...
This resource, which catalogs FDA authorizations, includes the Study Watch with Irregular Pulse Monitor (Home) from Verily among devices classified under product code DXH for electrocardiograph transmitters and receivers.
unknown

Videos

Product demos, reviews, and walkthroughs for Study Watch with Irregular Pulse Monitor (Home).

Loading videos...

View all on YouTube

Frequently Asked Questions

The watch is designed to passively collect data, which can then be securely transmitted to a physician portal for review. It aims to flag potential irregular pulse events, allowing for more targeted follow-up and potentially reducing the need for continuous in-office monitoring.
As a 'Study Watch,' it is primarily intended for investigational use within a research protocol, meaning specific regulatory clearances for diagnostic claims may be pending. Data transmission and storage adhere to stringent security protocols and encryption standards to ensure HIPAA compliance and patient data privacy.
While not a direct replacement for a diagnostic Holter, the watch provides long-term, real-world data collection, potentially identifying intermittent arrhythmias missed by shorter monitoring periods. Its AI focuses on early detection and trend analysis, complementing traditional diagnostic tools rather than replacing them.
As a study device, initial costs are typically covered by the research protocol; however, future commercial models would likely involve a device purchase or subscription fee for data services. Reimbursement for home monitoring devices is an evolving landscape, and specific CPT codes would need to be established for broader insurance coverage.
The AI is trained on specific datasets, and its accuracy can vary with different arrhythmia types and patient demographics. False positives may occur due to motion artifact, while false negatives could miss subtle or rare events, necessitating clinical correlation and further diagnostic testing for confirmation.
The AI algorithm undergoes rigorous validation using diverse datasets from various patient populations to minimize bias and ensure robust performance. Ongoing monitoring, real-world data analysis, and iterative updates are implemented to address any identified disparities in detection accuracy across different demographic groups.

Related Tools

EchoMD AutoEF
Caption Health (formerly Bay Labs, now part of GE HealthCare)
Cardiology AI
EchoMD AutoEF is an FDA-cleared AI software that automates the selection of echocardiogram clips and calculates left ventricular ejection fraction (EF), enhancing efficiency and accuracy in cardiac assessments.
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm
Anumana, Inc.
Cardiology AI
An AI algorithm for screening cardiac amyloidosis using standard 12-lead ECGs.
DEEPVESSEL Plaque
Keya Medical Technology Co., Ltd.
Cardiology AI
An AI software platform for coronary plaque analysis and quantification from CT angiography.
WatchMate Software
Anumana, Inc.
Cardiology AI
Anumana is an AI-driven health technology company from nference, developing and delivering ECG algorithms enabling early diagnosis and intervention.
syngo.CT Coronary Cockpit
Siemens Healthineers
Cardiology AI
syngo.CT Coronary Cockpit is an AI-powered software tool by Siemens Healthineers for efficient and accurate CT coronary angiography analysis.
HeartLung AI-CVD®
HeartLung Corporation
Cardiology AI
HeartLung AI-CVD® is an FDA-cleared AI-powered quantitative imaging tool that provides automated CT-derived measurements for assessing cardiovascular and multisystem risks opportunistically.

See all Cardiology AI tools →

More from Verily Life Sciences

Study Watch
Verily Life Sciences
Cardiology AI
Verily Study Watch is a prescription-only, sensor-based wearable device for non-invasive, continuous physiological monitoring in clinical research, collecting data like ECG, heart rate, and movement for analysis in Verily's cloud platform.
Study Watch with Irregular Pulse Monitor
Verily Life Sciences
Cardiology AI
The Verily Study Watch with Irregular Pulse Monitor is an FDA-cleared, prescription-only wearable device from Verily Life Sciences. It is designed for adult patients (22+) to monitor and record single-channel ECG rhythms and detect irregular pulses indicative of atrial fibrillation, primarily for use in clinical research and professional healthcare settings.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed Study Watch with Irregular Pulse Monitor (Home)

Funded through the company that built this tool.

AI Tool Finder
AI-powered search. Results may not be comprehensive.