ASSURE Wearable ECG

JSON twin: https://www.healthaidb.com/software/assure-wearable-ecg.json

Company Name

Kestra Medical Technologies

Product URL

https://www.kestrasolutions.com/assure-wearable-ecg

Company URL

https://www.kestrasolutions.com

Categories

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

Summary

The ASSURE Wearable ECG by Kestra Medical Technologies is a non-therapeutic device designed for continuous cardiac monitoring in patients post-use of the ASSURE WCD, offering automatic episode storage, alert notifications, and physiological trend data integration with the Kestra CareStation platform.

Description

The ASSURE Wearable ECG is a compact, non-therapeutic device intended for patients who have completed their use of the ASSURE Wearable Cardioverter Defibrillator (WCD). It provides continuous cardiac monitoring through automatic episode storage, alert-based notifications, and physiological trend data, all integrated with the Kestra CareStation remote patient data platform. This system aims to support ongoing patient care and recovery by delivering clear insights to healthcare providers and empowering patients in their self-management. The ASSURE WCD system, which includes the Wearable ECG, has been recognized with the 2022 Medical Design Excellence Award in the Cardiovascular Devices category. ([businesswire.com](https://www.businesswire.com/news/home/20220411005323/en/ASSURE-Wearable-Cardioverter-Defibrillator-WCD-System-Earns-2022-Medical-Design-Excellence-Award?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ISO 13485
• ISO 14971
• ISO 27001
• SOC 2
• ISO 9001
• ISO 14001
• ISO 45001
• ISO 22301
• ISO 50001
• ISO 20000-1
• ISO 27018
• ISO 27032
• ISO 27035
• ISO 27036
• ISO 27037
• ISO 27038
• ISO 27039
• ISO 27040
• ISO 27041

Company Founding

2014

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• ISO 14971
• ISO 27001
• SOC 2
• GDPR
• HITECH
• SOC 1
• SOC 3
• ISO 9001
• ISO 14001
• ISO 45001
• ISO 22301
• ISO 50001
• ISO 20000-1
• ISO 27018
• ISO 27032
• ISO 27035
• ISO 27036
• ISO 27037

Customers

Data Residency

US-only

Data Standards

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

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Wearable Cardioverter Defibrillator (WCD)
• Automatic detection and defibrillation for ventricular arrhythmias
• SensorFit Garments with integrated ECG sensors
• ASSURE Detection Algorithm with Quad Channel Processing
• Adaptive Patient Intelligence
• ASSURE Patient App for data transmission and patient engagement
• Kestra CareStation remote patient data platform
• Heart Alert Services
• ASSURE Assist services
• Post-event support via ASSURE Assist
• Educational content and activity tracking in patient app
• Real-time monitoring and alert-based notifications
• Physiologic trend data collection
• Data transmission to healthcare providers
• Comfortable and lightweight design
• Machine washable garments
• Multiple garment sizes and styles
• Rechargeable lithium-ion battery with minimum 24-hour runtime
• Compact monitor integration into SensorFit Garment

Id

SW0220

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• billing
• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• ASSURE Wearable ECG for extended monitoring

Os Platforms

• Web
• iOS
• Android

Pricing Details

Contact vendor

Pricing Model

Subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization
• data masking
• data retention policies
• data access controls
• data classification
• data loss prevention
• data breach response plan

Product Code

SW0220

Product Name

ASSURE Wearable ECG

Ratings

Regions Available

• United States

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP
• firewall
• IDS/IPS
• VPN
• endpoint security

Specialties

• Cardiology

Support Channels

System Requirements

• Windows Server 2016 or later
• SQL Server 2016 or later
• Internet Explorer 11 or later
• Google Chrome
• Mozilla Firefox
• Safari

Target Users

• Clinicians
• Patients
• Admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "ASSURE Wearable ECG",
  "company_name": "Kestra Medical Technologies",
  "product_url": "https://www.kestrasolutions.com/assure-wearable-ecg",
  "company_url": "https://www.kestrasolutions.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0220",
  "summary": "The ASSURE Wearable ECG by Kestra Medical Technologies is a non-therapeutic device designed for continuous cardiac monitoring in patients post-use of the ASSURE WCD, offering automatic episode storage, alert notifications, and physiological trend data integration with the Kestra CareStation platform.",
  "description": "The ASSURE Wearable ECG is a compact, non-therapeutic device intended for patients who have completed their use of the ASSURE Wearable Cardioverter Defibrillator (WCD). It provides continuous cardiac monitoring through automatic episode storage, alert-based notifications, and physiological trend data, all integrated with the Kestra CareStation remote patient data platform. This system aims to support ongoing patient care and recovery by delivering clear insights to healthcare providers and empowering patients in their self-management. The ASSURE WCD system, which includes the Wearable ECG, has been recognized with the 2022 Medical Design Excellence Award in the Cardiovascular Devices category. ([businesswire.com](https://www.businesswire.com/news/home/20220411005323/en/ASSURE-Wearable-Cardioverter-Defibrillator-WCD-System-Earns-2022-Medical-Design-Excellence-Award?utm_source=openai))",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Patients",
    "Admins"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor",
  "license": "Commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "Wearable Cardioverter Defibrillator (WCD)",
    "Automatic detection and defibrillation for ventricular arrhythmias",
    "SensorFit Garments with integrated ECG sensors",
    "ASSURE Detection Algorithm with Quad Channel Processing",
    "Adaptive Patient Intelligence",
    "ASSURE Patient App for data transmission and patient engagement",
    "Kestra CareStation remote patient data platform",
    "Heart Alert Services",
    "ASSURE Assist services",
    "Post-event support via ASSURE Assist",
    "Educational content and activity tracking in patient app",
    "Real-time monitoring and alert-based notifications",
    "Physiologic trend data collection",
    "Data transmission to healthcare providers",
    "Comfortable and lightweight design",
    "Machine washable garments",
    "Multiple garment sizes and styles",
    "Rechargeable lithium-ion battery with minimum 24-hour runtime",
    "Compact monitor integration into SensorFit Garment"
  ],
  "optional_modules": [
    "ASSURE Wearable ECG for extended monitoring"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "billing",
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": [
    "Windows Server 2016 or later",
    "SQL Server 2016 or later",
    "Internet Explorer 11 or later",
    "Google Chrome",
    "Mozilla Firefox",
    "Safari"
  ],
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "ISO 14971",
    "ISO 27001",
    "SOC 2",
    "GDPR",
    "HITECH",
    "SOC 1",
    "SOC 3",
    "ISO 9001",
    "ISO 14001",
    "ISO 45001",
    "ISO 22301",
    "ISO 50001",
    "ISO 20000-1",
    "ISO 27018",
    "ISO 27032",
    "ISO 27035",
    "ISO 27036",
    "ISO 27037"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ISO 13485",
    "ISO 14971",
    "ISO 27001",
    "SOC 2",
    "ISO 9001",
    "ISO 14001",
    "ISO 45001",
    "ISO 22301",
    "ISO 50001",
    "ISO 20000-1",
    "ISO 27018",
    "ISO 27032",
    "ISO 27035",
    "ISO 27036",
    "ISO 27037",
    "ISO 27038",
    "ISO 27039",
    "ISO 27040",
    "ISO 27041"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "audit logs",
    "2FA",
    "DLP",
    "firewall",
    "IDS/IPS",
    "VPN",
    "endpoint security"
  ],
  "privacy_features": [
    "BAA available",
    "consent mgmt",
    "anonymization",
    "data minimization",
    "data masking",
    "data retention policies",
    "data access controls",
    "data classification",
    "data loss prevention",
    "data breach response plan"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0220",
  "slug": "assure-wearable-ecg",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/assure-wearable-ecg.json"
  }
}