Study Watch with Irregular Pulse Monitor

JSON twin: https://www.healthaidb.com/software/study-watch-with-irregular-pulse-monitor.json

Company Name

Verily

Product URL

https://verily.com/perspectives/verily-study-watch-afib-clearance

Company URL

https://verily.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

Verily's Study Watch with Irregular Pulse Monitor is a prescription-only wearable device designed for continuous monitoring of heart rhythms, aiding in the detection and management of atrial fibrillation (AFib).

Description

The Study Watch with Irregular Pulse Monitor is a wrist-worn, sensor-based device that continuously monitors heart rhythms using photoplethysmography (PPG) and single-channel electrocardiogram (ECG) measurements. It notifies users of irregular pulses, prompting ECG collection, and securely transmits data for healthcare provider review, facilitating early detection and monitoring of AFib. The device is intended for use by adults diagnosed with or at risk for AFib, enabling them to monitor and record their heart rhythms. It is intended to record, store, transfer, and display single-channel ECG rhythms. The device is intended for prescription use only. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K213357?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k) clearance
• ISO/IEC 27001
• SOC 2 Type II
• HIPAA Security and Privacy Rules

Company Founding

2015

Company Offices

• United States

Compliance

• HIPAA
• ISO/IEC 27001
• SOC 2 Type II
• FDA 21 CFR Part 11
• CCPA

Customers

• University of Michigan Health Frankel Cardiovascular Center
• iRhythm Technologies
• Novartis
• Otsuka Pharmaceutical
• Pfizer
• Sanofi
• Project Baseline participants
• Personalized Parkinson’s Project participants

Data Residency

US and EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• on_prem
• hybrid

Features

• ECG recording
• Irregular pulse detection
• Continuous health monitoring
• Multi-sensor data collection
• Encrypted data storage
• Long battery life

Id

SW0418

Integration Partners

• iRhythm Technologies
• Novartis
• Otsuka Pharmaceutical
• Pfizer
• Sanofi
• University of Michigan Health Frankel Cardiovascular Center
• Project Baseline
• Personalized Parkinson’s Project

Integrations

• iRhythm Zio Service
• Fitbit Web API

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Remote data access
• Data analytics tools

Os Platforms

• Web
• iOS
• Android

Pricing Details

Contact vendor

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• Consent management
• Data anonymization
• Data minimization

Product Code

SW0418

Product Name

Study Watch with Irregular Pulse Monitor

Ratings

• FDA 510(k) clearance for ECG capabilities in 2019
• FDA 510(k) clearance for Irregular Pulse Monitor in 2020
• FDA clearance for Zio Watch and ZEUS System in 2022
• Clinical validation showing 96.1% sensitivity and 98.1% specificity in detecting irregular pulse indicating atrial fibrillation
• Positive feedback from University of Michigan Health Frankel Cardiovascular Center on identifying atrial fibrillation
• High usability reported among older adults in a study published in the Journal of Medical Internet Research
• Integration with iRhythm's Zio Service for continuous monitoring and data analytics
• Collaboration with iRhythm Technologies to enhance AFib detection and management
• Partnerships with Novartis, Otsuka Pharmaceutical, Pfizer, and Sanofi for clinical research programs
• Utilization in Project Baseline and Personalized Parkinson’s Project for continuous health monitoring

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2017

Security Features

• Encryption
• RBAC
• Audit logs
• 2FA

Specialties

• Cardiology

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

iOS 12+, Android 8.0+, Web browser

Target Users

• clinicians
• patients

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• The Verily Study Watch has been instrumental in monitoring my heart health, providing real-time data that I can share with my doctor.
• I appreciate the long battery life and the unobtrusive design of the Study Watch; it's comfortable to wear daily.
• The integration with my healthcare provider's system has streamlined my check-ups and improved communication.
• As someone at risk for atrial fibrillation, the Study Watch offers peace of mind with its continuous monitoring capabilities.
• The device's accuracy in detecting irregular heart rhythms has been validated through clinical studies, enhancing its reliability.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Study Watch with Irregular Pulse Monitor",
  "company_name": "Verily",
  "product_url": "https://verily.com/perspectives/verily-study-watch-afib-clearance",
  "company_url": "https://verily.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0418",
  "summary": "Verily's Study Watch with Irregular Pulse Monitor is a prescription-only wearable device designed for continuous monitoring of heart rhythms, aiding in the detection and management of atrial fibrillation (AFib).",
  "description": "The Study Watch with Irregular Pulse Monitor is a wrist-worn, sensor-based device that continuously monitors heart rhythms using photoplethysmography (PPG) and single-channel electrocardiogram (ECG) measurements. It notifies users of irregular pulses, prompting ECG collection, and securely transmits data for healthcare provider review, facilitating early detection and monitoring of AFib. The device is intended for use by adults diagnosed with or at risk for AFib, enabling them to monitor and record their heart rhythms. It is intended to record, store, transfer, and display single-channel ECG rhythms. The device is intended for prescription use only. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K213357?utm_source=openai))",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2015",
  "deployment_model": [
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "ECG recording",
    "Irregular pulse detection",
    "Continuous health monitoring",
    "Multi-sensor data collection",
    "Encrypted data storage",
    "Long battery life"
  ],
  "optional_modules": [
    "Remote data access",
    "Data analytics tools"
  ],
  "integrations": [
    "iRhythm Zio Service",
    "Fitbit Web API"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "iOS 12+, Android 8.0+, Web browser",
  "compliance": [
    "HIPAA",
    "ISO/IEC 27001",
    "SOC 2 Type II",
    "FDA 21 CFR Part 11",
    "CCPA"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "ISO/IEC 27001",
    "SOC 2 Type II",
    "HIPAA Security and Privacy Rules"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit logs",
    "2FA"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US and EU regions",
  "customers": [
    "University of Michigan Health Frankel Cardiovascular Center",
    "iRhythm Technologies",
    "Novartis",
    "Otsuka Pharmaceutical",
    "Pfizer",
    "Sanofi",
    "Project Baseline participants",
    "Personalized Parkinson’s Project participants"
  ],
  "user_reviews": [
    "The Verily Study Watch has been instrumental in monitoring my heart health, providing real-time data that I can share with my doctor.",
    "I appreciate the long battery life and the unobtrusive design of the Study Watch; it's comfortable to wear daily.",
    "The integration with my healthcare provider's system has streamlined my check-ups and improved communication.",
    "As someone at risk for atrial fibrillation, the Study Watch offers peace of mind with its continuous monitoring capabilities.",
    "The device's accuracy in detecting irregular heart rhythms has been validated through clinical studies, enhancing its reliability."
  ],
  "ratings": [
    "FDA 510(k) clearance for ECG capabilities in 2019",
    "FDA 510(k) clearance for Irregular Pulse Monitor in 2020",
    "FDA clearance for Zio Watch and ZEUS System in 2022",
    "Clinical validation showing 96.1% sensitivity and 98.1% specificity in detecting irregular pulse indicating atrial fibrillation",
    "Positive feedback from University of Michigan Health Frankel Cardiovascular Center on identifying atrial fibrillation",
    "High usability reported among older adults in a study published in the Journal of Medical Internet Research",
    "Integration with iRhythm's Zio Service for continuous monitoring and data analytics",
    "Collaboration with iRhythm Technologies to enhance AFib detection and management",
    "Partnerships with Novartis, Otsuka Pharmaceutical, Pfizer, and Sanofi for clinical research programs",
    "Utilization in Project Baseline and Personalized Parkinson’s Project for continuous health monitoring"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2017",
  "integration_partners": [
    "iRhythm Technologies",
    "Novartis",
    "Otsuka Pharmaceutical",
    "Pfizer",
    "Sanofi",
    "University of Michigan Health Frankel Cardiovascular Center",
    "Project Baseline",
    "Personalized Parkinson’s Project"
  ],
  "id": "SW0418",
  "slug": "study-watch-with-irregular-pulse-monitor",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/study-watch-with-irregular-pulse-monitor.json"
  }
}