Study Watch with Irregular Pulse Monitor
Overview
The Verily Study Watch with Irregular Pulse Monitor is a sophisticated, miniaturized physiological data monitoring device developed by Verily Life Sciences. It is specifically indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation. The device enables these patients to monitor and record their heart rhythms, and is also designed to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. A key feature is its ability to notify the user in the event of an irregular pulse, such as atrial fibrillation (AF), and recommend the acquisition of an ECG for further assessment. While cleared for use in professional healthcare facility environments and as a prescription-only device, the Study Watch also serves as a crucial tool in clinical research, capturing a wide array of biometric, environmental, and movement data for studies across various therapeutic areas, including cardiovascular health, Parkinson’s disease, and heart failure.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Single-channel ECG recording, storage, transfer, and display
- Irregular pulse monitoring and notification (e.g., for Atrial Fibrillation)
- Recommendation for ECG acquisition upon irregular pulse detection
- Built-in biometric, environmental, and movement sensors
- Continuous data capture with long battery life (e.g., 3-day for related Numetric Watch)
- Designed for clinical research and investigational use
- Easy-to-use interface and configurable firmware
- Supports multiple languages
- Remote data collection capabilities
Use Cases
- Monitoring adult patients (22+) with diagnosed or suspected atrial fibrillation
- Clinical research studies (e.g., Project Baseline, Aurora study, Parkinson's, Heart Failure)
- Screening, diagnosis, and management of atrial fibrillation
- Investigating digital biomarkers for various conditions (cardiovascular, CNS, metabolic, respiratory, oncology)
- Real-world evidence generation
- Longitudinal studies to understand health and disease progression
What Physicians Need to Know
The Verily Study Watch with Irregular Pulse Monitor serves as a valuable tool for continuous, prescription-based monitoring of patients at risk for or diagnosed with atrial fibrillation. Physicians should note that while the watch provides real-time prompts for ECG capture upon suspected irregular rhythms, the definitive analysis and interpretation of ECG waveforms are performed by a cardiographic technician and then made available to the HCP via a secure web portal. This workflow supports clinical decision-making by providing objective data for review. The device's accuracy in AFib detection, even during activity, makes it suitable for long-term surveillance in a real-world setting. Consider its use for patients requiring ongoing AFib monitoring where traditional intermittent methods may miss paroxysmal events.
The Verily Study Watch ecosystem facilitates data transfer to a secure cloud platform for HCP review. Future integrations with services like iRhythm's Zio aim to enhance data analytics and machine learning capabilities for AFib. The broader Verily platform, including Numetric Watch and collaborations with consumer wearables like the Samsung Galaxy Watch, highlights a strategic direction towards integrating diverse sensor data for comprehensive health monitoring and research, offering potential for more holistic patient insights in cardiovascular care.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing |
Contact for pricing
|
| Deployment | Device-based (wrist-worn watch) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
True AI-estimated The Study Watch with Irregular Pulse Monitor received 510(k) clearance (K192415 on January 17, 2020) as a Class II medical device for its irregular pulse monitor feature. It is indicated for adult patients (22 years and older) diagnosed with or susceptible to atrial fibrillation to monitor and record heart rhythms and display single-channel ECGs. It is a prescription-only device. An expanded indication (K213357 on July 19, 2022) includes home use and interoperability with the ZEUS System. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Family Medicine, Internal Medicine |
What the Web Says
The Verily Study Watch with Irregular Pulse Monitor is a prescription-only, wrist-worn device designed for clinical research and healthcare settings to detect irregular heart rhythms, specifically atrial fibrillation (AFib). It has received FDA 510(k) clearance for its irregular pulse monitor and ECG features. The watch utilizes photoplethysmography (PPG) to monitor heart rhythm and, if an irregular pulse is suspected, prompts the user to take a single-lead ECG for confirmation, with results reviewed by a cardiographic technician before being sent to a physician. The device is intended for adult patients (22 years and older) who have been diagnosed with or are susceptible to developing AFib.
Overall: PositiveStrengths
- FDA-cleared for irregular pulse monitoring and ECG, indicating a high level of accuracy and reliability for medical use.
- Designed for clinical-grade data collection, supporting robust research and clinical care.
- Accurate at identifying atrial fibrillation, with a study showing correct identification in the vast majority of participants.
- Offers continuous monitoring of heart rhythm.
- Integrates with healthcare providers through a cloud-based data network (as the Zio Watch).
- Long battery life due to simpler software and e-paper technology compared to consumer smartwatches.
Limitations
- Not directly available to consumers; it is a prescription-only device for clinical and professional healthcare use.
- Performance may decrease for some AFib episodes in participants with darker skin tones, though still able to detect AFib.
- Consumer-grade smartwatches, while popular, can lead to false positives for AFib, causing unnecessary testing and anxiety.
- Wrist-based optical sensors in general can have a high false positive rate and be affected by movement, poor skin contact, or sensor limitations.
- Some consumer smartwatches have limitations in detecting arrhythmias other than AFib or providing documentation-grade ECG data.
- Accuracy of wrist-based heart rate monitors can be affected by factors like temperature and sweat, and may not be as accurate as chest straps for exercise.
Based on reviews from: Verily moves further into heart research as Study Watch picks up new FDA clearance, Clinical smart watch finds success at identifying atrial fibrillation | Michigan Medicine, Verily Study Watch AFib clearance, NCT06041373 | Verily Watch Cardio (AF and ECG) Study | ClinicalTrials.gov, Verily's heart-tracking wearable evolves into the Zio Watch via iRhythm partnership, new FDA clearances - Fierce Biotech, Alphabet's Verily health watch gets limited ECG clearance from FDA - CNET, Verily Study Watch Irregular Heartbeat Detection Clears FDA - SlashGear, July 19, 2022 Verily Life Sciences LLC Dinesh Puppala Regulatory Affairs Specialist 269 East Grand Avenue South San Francisco, C - accessdata.fda.gov, health monitor watch flagging irregular rhythm, sensor error or worth worrying about? : r/HealthTech - Reddit, Physician Responses to Apple Watch-Detected Irregular Rhythm Alerts - PMC - NIH, Verily nets irregular pulse clearance for its clinical study smartwatch | Fierce Biotech, Smartwatches and Atrial Fibrillation: What Works and What Needs Improvement?, Performance of the Verily Study Watch for measuring sleep compared to polysomnography, Consumer-grade wearable cardiac monitors: What they do well, and what needs work, Wrist heart rate monitors on smart watches are not as accurate as a chest strap - Reddit, What's the best smart watch for monitoring heart rythm? : r/AFIB - Reddit, Want to monitor heart irregularities. Should I buy smartwatch? - Mayo Clinic Connect, Comparison of diagnostic accuracy of electrocardiogram-based versus photoplethysmography-based smartwatches for atrial fibrillation detection: A Systematic Review and Meta-Analysis, Best Heart Monitors of 2026: Physician-Tested Accuracy Rankings
Last updated: 2026-07-20
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