ILR ECG Analyzer

JSON twin: https://www.healthaidb.com/software/ilr-ecg-analyzer.json

Company Name

Implicity

Product URL

https://www.implicity.com/ilr-ecg-analyzer/

Company URL

https://www.implicity.com

Categories

• clinical Care
• diagnostic Support
• cardiology
• remote Monitoring
• ai Clinical Documentation Integrity
• clinical Decision Support
• Clinical
• Diagnostic
• Artificial Intelligence

Summary

ILR ECG Analyzer is an AI-driven software that enhances arrhythmia detection by reducing false positives in ECG data from Medtronic implantable loop recorders, improving remote monitoring efficiency for healthcare providers.

Description

ILR ECG Analyzer is an FDA-cleared Class II medical device developed by Implicity to analyze ECG recordings from patients implanted with Medtronic implantable loop recorders (ILRs). Utilizing artificial intelligence, it reduces false positives by 79% while maintaining a sensitivity of 99%, thereby improving arrhythmia detection and allowing healthcare providers to focus on meaningful cardiac events. This software is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. It supports downloading and analyzing data recorded in compatible formats from ICMs, specifically Medtronic models LNQ11, REVEAL XT 9529, and REVEAL DX 9528. The ILR ECG Analyzer provides ECG signal processing and analysis to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm, and artifacts. It is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The interpretation results are intended to be used in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. The software is interfaced with compatible remote monitoring platforms to receive ICM data file input and transmit the output for viewing by healthcare professionals. The ILR ECG Analyzer is CE marked as a Class I medical device under the Medical Device Directive 93/42.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE marking under MDD 93/42/EEC

Company Founding

2018

Company Offices

• United States
• France

Compliance

• FDA 510(k) clearance
• CE marking under MDD 93/42/EEC

Customers

Data Residency

EU data privacy compliant

Data Standards

• ECG data formats compatible with Medtronic ILRs

Deployment Model

• SaaS

Features

• AI-driven ECG analysis
• False positive reduction by 79%
• Sensitivity of 99%
• Compatible with Medtronic ILRs
• Interfaces with remote monitoring platforms

Id

SW0441

Integration Partners

Integrations

• Medtronic Reveal LINQ
• Medtronic Reveal XT
• Medtronic Reveal DX
• Remote monitoring platforms

Languages Supported

• English
• French

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• InLink
• AF Alert Management
• Patient Connectivity Management
• Heart Failure Remote Monitoring
• Advanced Research Tool

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Data anonymization
• Compliance with data privacy regulations

Product Code

SW0441

Product Name

ILR ECG Analyzer

Ratings

Regions Available

• United States
• European Union

Related Urls

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

Release Year

Security Features

• Data encryption
• Secure data transmission

Specialties

• Cardiology
• Electrophysiology
• Arrhythmia Management

Support Channels

System Requirements

Target Users

• Clinicians
• Electrophysiologists
• Cardiologists
• Healthcare Providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "ILR ECG Analyzer",
  "company_name": "Implicity",
  "product_url": "https://www.implicity.com/ilr-ecg-analyzer/",
  "company_url": "https://www.implicity.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0441",
  "summary": "ILR ECG Analyzer is an AI-driven software that enhances arrhythmia detection by reducing false positives in ECG data from Medtronic implantable loop recorders, improving remote monitoring efficiency for healthcare providers.",
  "description": "ILR ECG Analyzer is an FDA-cleared Class II medical device developed by Implicity to analyze ECG recordings from patients implanted with Medtronic implantable loop recorders (ILRs). Utilizing artificial intelligence, it reduces false positives by 79% while maintaining a sensitivity of 99%, thereby improving arrhythmia detection and allowing healthcare providers to focus on meaningful cardiac events. This software is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. It supports downloading and analyzing data recorded in compatible formats from ICMs, specifically Medtronic models LNQ11, REVEAL XT 9529, and REVEAL DX 9528. The ILR ECG Analyzer provides ECG signal processing and analysis to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm, and artifacts. It is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The interpretation results are intended to be used in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. The software is interfaced with compatible remote monitoring platforms to receive ICM data file input and transmit the output for viewing by healthcare professionals. The ILR ECG Analyzer is CE marked as a Class I medical device under the Medical Device Directive 93/42.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "cardiology",
    "remote Monitoring",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "Clinical",
    "Diagnostic",
    "Cardiology",
    "Remote Monitoring",
    "Artificial Intelligence"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Electrophysiologists",
    "Cardiologists",
    "Healthcare Providers"
  ],
  "specialties": [
    "Cardiology",
    "Electrophysiology",
    "Arrhythmia Management"
  ],
  "regions_available": [
    "United States",
    "European Union"
  ],
  "languages_supported": [
    "English",
    "French"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "France"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-driven ECG analysis",
    "False positive reduction by 79%",
    "Sensitivity of 99%",
    "Compatible with Medtronic ILRs",
    "Interfaces with remote monitoring platforms"
  ],
  "optional_modules": [
    "InLink",
    "AF Alert Management",
    "Patient Connectivity Management",
    "Heart Failure Remote Monitoring",
    "Advanced Research Tool"
  ],
  "integrations": [
    "Medtronic Reveal LINQ",
    "Medtronic Reveal XT",
    "Medtronic Reveal DX",
    "Remote monitoring platforms"
  ],
  "data_standards": [
    "ECG data formats compatible with Medtronic ILRs"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "FDA 510(k) clearance",
    "CE marking under MDD 93/42/EEC"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE marking under MDD 93/42/EEC"
  ],
  "security_features": [
    "Data encryption",
    "Secure data transmission"
  ],
  "privacy_features": [
    "Data anonymization",
    "Compliance with data privacy regulations"
  ],
  "data_residency": "EU data privacy compliant",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0441",
  "slug": "ilr-ecg-analyzer",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/ilr-ecg-analyzer.json"
  }
}