Reveal LINQ Insertable Cardiac Monitor

by Medtronic  · Based in Ireland → — Accuracy matters.
Cardiology Pediatrics
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Regulatory Status Disclosed

Overview

The Medtronic LINQ II™ Insertable Cardiac Monitor (ICM) with AccuRhythm™ AI algorithms is an advanced system designed for long-term heart monitoring. It is a small device placed just under the skin that continuously monitors and records subcutaneous ECG. The AccuRhythm™ AI algorithms are a groundbreaking platform that applies deep learning artificial intelligence to LINQ II™ data flowing into the CareLink™ network. This cloud-based AI system significantly reduces false alerts for atrial fibrillation (AF) and Pause episodes, while preserving true alerts, thereby enhancing the accuracy of heart rhythm data and aiding in clinical adjudication. The LINQ II ICM offers up to 4.5 years of battery longevity and is designed to provide clarity without compromise, allowing clinicians to focus more on patient care by managing diagnostic yield efficiently. It is also the first insertable cardiac monitor with an indication for pediatric use (for ages two and older).

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AccuRhythmu2122 AI algorithms for reduced false alerts (AF and Pause)
  • 4.5-year battery longevity (nominal settings)
  • Continuous, long-term subcutaneous ECG monitoring
  • Remote programming capabilities
  • Enhanced ECG experience for clinical adjudication
  • MyCareLink Heartu2122 mobile app for patient data transmission
  • MyCareLink Relayu2122 home communicator for data transmission
  • MRI compatible (at u2264 3T with no post-insertion waiting)
  • Indication for pediatric use (ages two and older)
  • Automatic and patient-activated monitoring

Use Cases

  • Patients with clinical syndromes at increased risk of cardiac arrhythmias
  • Patients experiencing transient symptoms (dizziness, palpitation, syncope, chest pain) suggesting cardiac arrhythmia
  • Diagnosis of unexplained fainting
  • Management and diagnosis of atrial fibrillation (AFib)
  • Detection of abnormal heart rhythms for stroke prevention (cryptogenic stroke)
  • Long-term monitoring for ongoing management of heart conditions

What Physicians Need to Know

ECG/EKG Analysis Capability
The Reveal LINQ ICM continuously records subcutaneous ECG for up to three years, storing up to 27 minutes of automatically detected arrhythmias and 30 minutes of patient-activated episodes. It offers an enhanced ECG experience with high-resolution, vector graphics, and an advanced Interactive ECG viewer for clinical adjudication. The device also captures AF burden, heart rate variability, and daily activity data.
Cardiac CT/MRI Analysis
The Reveal LINQ ICM is MR-Conditional at both 1.5T and 3T, allowing patients to undergo MRI scans without post-insertion waiting. Studies indicate that the device does not produce clinically significant artifact on thoracic CT or cardiac MRI imaging, and no adverse patient safety or data loss events have been noted during MRI scanning.
Arrhythmia Detection Accuracy
The device features AccuRhythmu2122 artificial intelligence (AI) algorithms, which significantly reduce false alerts for atrial fibrillation (AF) and pause episodes by an estimated 85% while maintaining high sensitivity. The LINQ family of ICMs boasts an overall AF detection accuracy rate of 99.7%. Earlier versions reported 98% AF detection accuracy in patients with paroxysmal AF. Newer self-learning AF algorithms have reduced false detections by 49% compared to previous iterations, and false bradycardia and pause episodes by 95% and 47% respectively. While detection accuracy for tachycardia was 86% and bradycardia 82%, pause event detection was reported at 30% in one study.
Heart Failure Risk Prediction
The Reveal LINQ ICM is being evaluated in the ALLEVIATE-HF clinical trial for its ability to identify patients at high risk of worsening heart failure. A proprietary algorithm, when added to the system, can alert clinicians to early signs of worsening heart failure via nightly transmissions. Research has also shown that an ICM-based, multiparameter Heart Failure Risk Score (HFRS) can predict heart failure events with a sensitivity of 68.4-73.7%, providing a median early warning of 47-64 days. AI-based algorithms in the LINQ family of ICMs can quantify AF burden to predict the risk of AF-related healthcare utilization 80% of the time.
Cardiac Monitoring Integration
The Reveal LINQ ICM wirelessly communicates with the MyCareLink Patient Monitor, a bedside unit that collects heart rhythm data and uploads it to the Medtronic CareLink network using global cellular technology. This system provides clinicians with remote access to patient data and enables them to receive notifications of cardiac events. The Reveal LINQ Mobile Manager app facilitates device programming and interrogation. Patient demographics and monitoring reasons can be pre-configured to streamline workflow.
AHA/ACC Guideline Alignment
The Reveal LINQ ICM is indicated for patients with clinical syndromes or situations at increased risk of cardiac arrhythmias and those experiencing transient symptoms suggestive of arrhythmia, aligning with general diagnostic guidelines for such conditions. Medtronic references the 2018 ACC/AHA/HRS guideline on bradycardia and cardiac conduction delay in its publications related to the Reveal family.
Real-Time Alert Capability
The CareLink Network allows physicians to request notifications for cardiac events. With the heart failure algorithm, clinicians receive alerts for worsening heart failure signs via nightly transmissions. The AccuRhythm AI algorithms are automatically applied in the cloud, requiring no patient action for enhanced alert accuracy. While automatic wireless alerts can be disabled in specific scenarios (e.g., premature Recommended Replacement Time alert), manual remote transmissions remain possible.
Physician Tip

The Reveal LINQ ICM offers long-term, continuous ECG monitoring with advanced AI algorithms (AccuRhythmu2122) to enhance arrhythmia detection accuracy and significantly reduce false alerts, thereby streamlining review burden. Its MRI-conditional design provides flexibility for diagnostic imaging. For patients with unexplained syncope, palpitations, cryptogenic stroke, or those at risk for AF, this device can provide crucial diagnostic data. Furthermore, the ongoing development of heart failure risk prediction algorithms suggests an expanding role in proactive patient management. Emphasize patient education on the MyCareLink monitor for consistent data transmission and the use of the Patient Assistant for symptomatic event marking.

The Reveal LINQ ICM seamlessly integrates with the Medtronic CareLink network via the MyCareLink Patient Monitor, enabling wireless, remote data transmission and clinician alerts. The Reveal LINQ Mobile Manager app supports device programming and interrogation, enhancing workflow efficiency. Future integrations are focused on leveraging AI for broader diagnostic and predictive capabilities, such as heart failure risk stratification, directly within the existing CareLink infrastructure.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact vendor
  • Pricing for medical devices like the LINQ II ICM is typically not publicly disclosed and requires direct consultation with Medtronic sales representatives
DeploymentImplantable device with data transmitted to a cloud-based platform (CareLink™ network) via patient smartphone app or home communicator.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The AccuRhythm™ AI ECG Classification System (K223630) received U.S. Food and Drug Administration (FDA) clearance on April 5, 2023, for its algorithms to improve the accuracy of heart rhythm event data from the LINQ II™ and Reveal LINQ™ insertable cardiac monitors.
Integrations
EHR Not specified
Specialties Cardiology, Pediatrics

What the Web Says

The Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) is a small, subcutaneous device designed for long-term continuous heart rhythm monitoring, often used for patients with infrequent symptoms like dizziness, palpitations, syncope, or those at risk for cardiac arrhythmias or cryptogenic stroke. Physicians and patients generally report positive experiences, highlighting its ease of implantation and its effectiveness in diagnosing elusive heart conditions that traditional monitors might miss. The device's ability to wirelessly transmit data daily to healthcare providers is a significant advancement, allowing for timely diagnosis and treatment adjustments.

Overall: Positive

Strengths

  • Minimally invasive and quick implantation procedure, often performed in-office with local anesthetic.
  • Small size, about one-third the size of a AAA battery, making it less noticeable for patients.
  • Long battery life, typically up to three years, providing extended monitoring.
  • Effective in detecting infrequent and asymptomatic arrhythmias that other monitoring methods might miss, leading to earlier diagnosis and treatment.
  • Wireless daily data transmission to healthcare providers via a cellular-based bedside monitor or smartphone app, enabling timely alerts and interventions.
  • Provides peace of mind for patients knowing their heart activity is continuously monitored.

Limitations

  • Some patients report discomfort or pain at the implant site, especially when lying on their chest or during physical activity.
  • The associated costs, including the device itself, implantation procedure, and potential monthly monitoring fees, can be a concern for patients.
  • The app used for symptom recording can be glitchy at times, leading some to prefer a separate remote/clicker device.
  • While effective, it does not record and transmit all heart rhythm data continuously; it primarily focuses on detected episodes or patient-activated recordings.
  • False bradycardia detection due to undersensing and false tachycardia detection due to oversensing have been reported in some clinical studies.
  • Transmission failures can occur due to incomplete data reception or the patient being out of range.

Based on reviews from: Medtronic, Life of an Auntie And Mum, Reddit (r/askCardiology), Oxford Academic, PMC, YouTube, Mayo Clinic Connect, DAIC, Stories of Our Boys, Reddit (r/AFIB)

Last updated: 2026-07-20

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Press & Coverage

Medtronic
Medtronic celebrates 10 years of Reveal LINQu2122 ICM by adding artificial intelligence algorithms
Medtronic has updated all Reveal LINQu2122 Insertable Cardiac Monitor (ICM) devices in the U.S., Australia, and New Zealand with artificial intelligence algorithms (AccuRhythmu2122 AI) to reduce false alerts and improve data accuracy. This cloud-based update, announced in May 2024, is expected to reduce false alerts for atrial fibrillation and pause by 85%, saving clinics significant review time.
2024-05
Medtronic
Clinical study observations published in JACC show Medtronic Reveal LINQ Insertable Cardiac Monitors identify high incidence of arrhythmias in heart failure patients
A new analysis from the ALLEVIATE-HF clinical trial, published in the Journal of American College of Cardiology (JACC) in May 2026, found that over 77% of heart failure patients with a Reveal LINQu2122 ICM experienced arrhythmias within two years, leading to a high rate of guideline-recommended therapies. This highlights the device's effectiveness in detecting actionable arrhythmias in this patient population.
2026-05
Medtronic
Medtronic LINQ Insertable Cardiac Monitors prove cost-effective compared to standard of care in ischemic stroke patients with suspected atrial fibrillation
New cost-effectiveness data from the STROKE AF clinical study, released in February 2024, showed that continuous monitoring with the Medtronic Reveal LINQu2122 ICM is significantly more cost-effective than standard care for ischemic stroke patients with large artery and small vessel disease. The study, published in JAMA Neurology, demonstrated a 10-fold increase in AF detection with the Reveal LINQ ICM at three years.
2024-02
Medtronic
Medtronic Announces Global Launch of Miniature Cardiac Monitor, Reveal LINQ(TM) ICM
Medtronic announced the global launch of its Reveal LINQu2122 Insertable Cardiac Monitor (ICM) System in February 2014, following U.S. FDA 510(k) clearance and CE Mark. The device is the smallest implantable cardiac monitor available, approximately one-third the size of a AAA battery, and provides long-term remote monitoring for up to three years.
2014-02
RT - Respiratory Therapy
FDA OKs New Insertable Cardiac Monitor from Medtronic | RT - Respiratory Therapy
The U.S. FDA granted 510(k) clearance for Medtronic's Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection in March 2017. This advanced cardiac monitor offers improved accuracy in identifying abnormal heartbeats, with exclusive algorithms reducing false bradycardia and pause episodes.
2017-03
Medtronic
Medtronic Announces Approval and Launch of Reveal LINQ(TM) Insertable Cardiac Monitor in Japan
Medtronic announced in September 2016 that its Reveal LINQ Insertable Cardiac Monitor (ICM) System received Ministry of Health, Labor and Welfare (MHLW) approval and reimbursement approval in Japan. The miniaturized device is used for diagnosing unexplained syncope and cryptogenic stroke.
2016-09
Medtronic
Medtronic Initiates Study Of 'In-Office' Insertion Of Reveal LINQu2122 Cardiac Monitor
Medtronic initiated the Reveal LINQ In-Office 2 (RIO 2) Study in May 2015 to evaluate the safety and effectiveness of implanting the Reveal LINQu2122 ICM in an office setting rather than a traditional hospital setting. The study aims to potentially increase patient access to the device and reduce healthcare costs.
2015-05
PR Newswire
Medtronic Evaluates Insertable Cardiac Monitor in Identifying Patients at High Risk of Worsening Heart Failure
In September 2020, Medtronic announced the first enrollments in the ALLEVIATE-HF clinical trial, which will assess the Reveal LINQu2122 ICM's ability to identify patients at high risk of worsening heart failure. The trial seeks to determine if early information from the device can enable clinicians to intervene before a patient's condition deteriorates.
2020-09

Videos

Product demos, reviews, and walkthroughs for Reveal LINQ Insertable Cardiac Monitor.

View all on YouTube

Frequently Asked Questions

The Reveal LINQ ICM utilizes AccuRhythmu2122 AI algorithms, a deep learning platform that processes data flowing into the CareLinku2122 network. These algorithms significantly reduce false alerts for atrial fibrillation (AF) and pause episodes, thereby improving diagnostic accuracy and preserving sensitivity for true cardiac events.
Data within the Reveal LINQ system's app is protected by application-level encryption, and security measures are recommended for the associated tablet. The AccuRhythm AI platform has received U.S. Food and Drug Administration (FDA) clearance, ensuring it meets regulatory standards for medical devices.
While general pricing trends for the Reveal LINQ ICM exist, specific details regarding separate pricing or subscription models for the AccuRhythm AI algorithms or advanced data analytics were not explicitly found in the available information. Pricing can vary geographically and by facility.
While the AccuRhythm AI algorithms are designed to significantly reduce false alerts for AF and pause, older Reveal devices had limitations with false diagnoses due to artifacts or poor R-wave sensing. Studies have shown that even with AI, some false positives can still occur, though at a much reduced rate.
The AI algorithms are designed to substantially reduce the burden of reviewing false alerts, with estimates suggesting a reduction of up to 85% for AF and pause. This efficiency gain allows clinicians to focus more on critical patient care activities rather than sifting through erroneous data.
The Reveal LINQ ICM transmits data to the CareLinku2122 network, and the Reveal LINQu2122 Mobile Manager app is used for device management. While the CareLink network facilitates remote monitoring, specific native integrations of the AI-analyzed data with various EHR systems were not detailed, though general healthcare integration solutions exist.

Compare Reveal LINQ Insertable Cardiac Monitor

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These two tools are adjacent in their comparability, both leveraging AI in cardiology but with distinct applications. Reveal LINQ is an implantable device for long-term, continuous heart rhythm…
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These tools are adjacent competitors, both offering AI-powered remote cardiac monitoring. Reveal LINQ is an implantable device designed for long-term, continuous ECG monitoring and reducing false alerts for…
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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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