Reveal LINQ
by Medtronic
· Based in Ireland →
— The world's smallest insertable cardiac monitor with AI-powered accuracy.
Contact vendor for pricing
Regulatory Status Disclosed
Overview
The Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM) is a tiny, implantable medical device designed for long-term, continuous heart rhythm monitoring. It is approximately one-third the size of a AAA battery and is placed just under the skin through a minimally invasive procedure. The device continuously records subcutaneous ECG for up to three years, helping to diagnose infrequent and unexplained cardiac arrhythmias such as atrial fibrillation (AF), cryptogenic stroke, and unexplained syncope. The Reveal LINQ ICM features AccuRhythm™ artificial intelligence (AI) algorithms, which apply deep learning to data flowing into the CareLink™ network to significantly reduce false alerts from AF and pause events while preserving sensitivity. It is not an AI tool for a physician directory, but rather a diagnostic medical device with integrated AI for enhanced detection accuracy.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- World's smallest insertable cardiac monitor (1.2 mL)
- Continuous ECG monitoring for up to three years
- AccuRhythmu2122 AI algorithms for reduced false alerts (AF and pause)
- Automatic and patient-activated event recording
- MRI Conditional (1.5T and 3T) with no post-insertion waiting
- Minimally invasive, simplified insertion procedure
- Wireless data transmission to CareLinku2122 network via MyCareLinku2122 Patient Monitor
- Reveal LINQu2122 Mobile Manager app for clinician device management
- Enhanced ECG experience for clinical adjudication
- Long-term monitoring for infrequent symptoms
Use Cases
- Diagnosis of atrial fibrillation (AF)
- Diagnosis of cryptogenic stroke
- Diagnosis of unexplained syncope (fainting)
- Evaluation of palpitations
- Monitoring patients at increased risk of cardiac arrhythmias
- Assessing treatment effectiveness after cardiac procedures
What Physicians Need to Know
ECG/EKG Analysis Capability
The Reveal LINQ Insertable Cardiac Monitor (ICM) continuously monitors subcutaneous ECG, providing an enhanced ECG experience with high-resolution, vector graphics, and an advanced Interactive ECG viewer. It automatically records and stores ECG data for detected arrhythmias and patient-activated episodes, with capacity for up to 57 minutes of ECG recordings. The device incorporates improved algorithms for accurate detection of P waves and R waves.
Cardiac CT/MRI Analysis
While the Reveal LINQ does not perform cardiac CT/MRI analysis, it is an MR Conditional device, safe for use in 1.5T and 3T MRI environments with no post-insertion waiting period, provided specific conditions and precautions are followed.
Arrhythmia Detection Accuracy
The Reveal LINQ features AccuRhythmu2122 artificial intelligence (AI) algorithms, which apply deep learning to ICM data to significantly reduce false alerts for atrial fibrillation (AF) and pause episodes while maintaining sensitivity. These AI algorithms are expected to reduce false AF alerts by 85% and false pause alerts by 78.4%. The device boasts a high AF detection accuracy rate of 99.7%. It automatically detects and records various arrhythmias, including atrial tachyarrhythmia/AF, bradyarrhythmia, pause, and ventricular tachyarrhythmia.
Heart Failure Risk Prediction
Medtronic is evaluating the Reveal LINQ's capability to identify patients at high risk of worsening heart failure through the ALLEVIATE-HF clinical trial. An investigational proprietary algorithm, added to the Reveal LINQ system for this study, is designed to alert clinicians to early signs of worsening heart failure. This algorithm utilizes diagnostic parameters from ECG (AF, ventricular rate during AF, heart rate variability, night heart rate), a three-axis accelerometer (patient activity), and bioimpedance (fluid status and respiration rate) to assess heart failure risk. Early data suggests that high-risk patients identified by ICMs with this investigational software were eight times more likely to experience worsening heart failure within 30 days. Additionally, AI-based algorithms in the LINQ family of ICMs have shown the ability to predict patients' risk of needing AF-related healthcare.
Cardiac Monitoring Integration
The Reveal LINQ ICM wirelessly communicates with the MyCareLinku2122 Patient Monitor, a bedside unit that collects heart rhythm data and transmits it to the Medtronic CareLinku2122 network for physician review. The Reveal LINQu2122 mobile manager, an app-based system, facilitates device activation, programming, and checks for healthcare personnel, utilizing a patient connector with Bluetoothu00ae technology to transmit data. The system provides continuous and wireless cardiac monitoring for up to three years.
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 such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia. These indications are consistent with established guidelines for long-term cardiac monitoring, including references to the 2018 ESC Guidelines for Diagnosis and Management of Syncope and the 2018 ACC/AHA/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay.
Real-Time Alert Capability
The AccuRhythmu2122 AI algorithms are designed to reduce false alerts while preserving true alerts, ensuring clinicians receive clinically meaningful and actionable notifications. In the context of the ALLEVIATE-HF trial, the LINQ device is intended to alert clinicians to signs of worsening heart failure, enabling timely intervention. The remote monitoring capabilities of the Reveal LINQ facilitate earlier diagnosis of asymptomatic but serious arrhythmias, potentially months before a scheduled in-office evaluation.
Physician Tip
Leverage the AccuRhythmu2122 AI algorithms to significantly reduce false positive alerts for AF and pause, thereby streamlining ECG review and focusing on actionable data. Utilize the continuous, long-term monitoring capabilities for comprehensive arrhythmia detection in patients with infrequent symptoms or cryptogenic stroke. Consider the investigational heart failure risk prediction algorithm (ALLEVIATE-HF) for proactive management of high-risk heart failure patients, allowing for earlier intervention based on remote data. Ensure patients understand the use of the MyCareLinku2122 Patient Monitor for daily data transmission and the Patient Assistant for symptomatic event marking.
The Reveal LINQ ICM integrates seamlessly with the Medtronic CareLinku2122 network via the MyCareLinku2122 Patient Monitor for wireless data transmission. Healthcare professionals can manage devices using the Reveal LINQu2122 mobile manager app, which connects to the ICM via a patient connector using Bluetoothu00ae technology. This cloud-based AI platform allows for remote application of advanced algorithms without patient intervention.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing |
Contact vendor for pricing
|
| Deployment | Implantable medical device with a bedside patient monitor (MyCareLink™) for data transmission and a mobile app (Reveal LINQ™ Mobile Manager) for clinicians. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated The Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm™ Detection received U.S. FDA 510(k) clearance on March 13, 2017 (K162855). This clearance was for an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats, with algorithms reducing false bradycardia, pause, and atrial fibrillation episodes. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Neurology |
What the Web Says
The Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) is generally well-regarded for its small size, ease of insertion, and long battery life, making it a convenient option for long-term cardiac monitoring. Physicians appreciate its ability to provide continuous, accurate data for diagnosing infrequent arrhythmias, while patients benefit from its discreet nature. However, some concerns exist regarding data transmission reliability and the potential for false positives or over-detection in certain scenarios.
Overall: PositiveStrengths
- Extremely small size and minimally invasive insertion procedure.
- Long battery life (up to 3 years) for extended monitoring.
- Continuous, automatic monitoring for infrequent arrhythmias.
- Wireless data transmission to remote monitoring systems.
- Improved diagnostic yield for unexplained syncope and palpitations.
- Patient-friendly and discreet.
Limitations
- Potential for data transmission issues or connectivity problems.
- Risk of false positive detections or over-sensing.
- Requires patient engagement for manual event recording.
- Cost can be a barrier for some healthcare systems or patients.
- Limited real-time data access for immediate intervention.
- Some reports of discomfort or skin irritation at the insertion site.
Based on reviews from: Medtronic.com, Reddit (various cardiology and medical subreddits), Physician forums and medical journals, Healthcare IT reviews (general discussions on medical device integration), Cardiology professional opinions
Last updated: 2026-07-19
Ratings & Reviews
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Press & Coverage
Medtronic
Medtronic celebrates 10 years of Reveal LINQu2122 ICM by adding artificial intelligence algorithms
Medtronic has enhanced its Reveal LINQu2122 Insertable Cardiac Monitor (ICM) with artificial intelligence (AccuRhythmu2122 AI) capabilities, reducing false alerts by 85% for atrial fibrillation and pause, and improving information accuracy. This cloud-based update, applied to devices in the U.S., Australia, and New Zealand, marks 10 years since the Reveal LINQ ICM's launch, which has helped over 750,000 patients globally.
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
New insights from the ALLEVIATE-HF clinical trial, published in the Journal of American College of Cardiology (JACC), reveal 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 study highlights the significant burden of clinically meaningful arrhythmias in heart failure patients, often underestimated.
2026-05
Medtronic
Medtronic LINQu2122 family of insertable cardiac monitors with AI-based algorithms accurately predicts risk thresholds for patients with atrial fibrillation
Primary results from the DEFINE AFib clinical study, presented at AF Symposium 2025, demonstrate that the Medtronic LINQ family of ICMs with AI-based algorithms accurately predicted the risk of AF-related healthcare utilization in atrial fibrillation patients 80% of the time. The study also showed that these ICMs had four times greater episode sensitivity compared to the Apple Watch for AF detection.
2025-01
American Heart Association Journals
Global Results of Implantable Loop Recorder for Detection of Atrial Fibrillation After Stroke: Reveal LINQ Registry
A prospective, observational study from the Reveal LINQ Registry, published in October 2024, aimed to quantify the incidence of atrial fibrillation (AF) in cryptogenic stroke patients globally. The study, involving 271 patients from 12 countries, found AF was detected in 28.2% of patients within 36 months of Reveal LINQ insertion.
2024-10
Diagnostic and Interventional Cardiology
Medtronic Receives FDA Clearance for Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection
Medtronic received U.S. FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection in March 2017. This advanced cardiac monitor offers improved accuracy in identifying abnormal heartbeats, with algorithms that reduce false bradycardia episodes by 95% and false pause episodes by 47% compared to its predecessor.
2017-03
Medtronic
Medtronic Announces Approval and Launch of Reveal LINQ(TM) Insertable Cardiac Monitor in Japan
Medtronic announced in September 2016 the Ministry of Health, Labor and Welfare (MHLW) approval and reimbursement approval for the Reveal LINQ Insertable Cardiac Monitor (ICM) System in Japan. This miniaturized device, approximately one-third the size of a AAA battery, is designed for quick and accurate diagnosis of irregular heartbeats in patients with unexplained syncope and cryptogenic stroke.
2016-09
Medtronic
Medtronic Announces Global Launch of Miniature Cardiac Monitor, Reveal LINQ(TM) ICM
In February 2014, Medtronic announced the global launch of the Reveal LINQu2122 ICM, a miniature cardiac monitor significantly smaller than previous ICMs, yet offering 20% more data memory. This device continuously and wirelessly monitors a patient's heart for up to three years and provides remote monitoring through the Carelinku00ae Network.
2014-02
PMC (via Hippokratio General Hospital of Thessaloniki)
Effectiveness and safety of the Reveal LINQTM implantable loop recorder - first clinical results
A retrospective study published in 2019 evaluated the clinical efficacy, safety, and diagnostic ability of the Reveal LINQu2122 insertable cardiac monitoring system in seven patients. The study concluded that the device, easily implanted on an outpatient basis, provides remarkable data for diagnosing and treating patients with syncopal episodes or palpitations.
2019-07
Videos
Product demos, reviews, and walkthroughs for Reveal LINQ.
Reveal LINQu2122 System Introduction for Patients
Frequently Asked Questions
Reveal LINQ, specifically with its AccuRhythmu2122 AI algorithms, leverages deep learning to analyze ECG data, significantly reducing false alerts for atrial fibrillation (AF) and pause episodes while preserving true alerts. This AI-driven analysis helps physicians focus on clinically significant events, streamlining the diagnostic process and potentially leading to earlier interventions by saving clinics substantial review time.
Reveal LINQ's AccuRhythm AI platform received U.S. Food and Drug Administration (FDA) market clearance for use with Reveal LINQ ICMs in April 2023. As a medical device with AI capabilities, it adheres to FDA guidelines for AI/ML-based software as a medical device (SaMD), ensuring its safety and effectiveness. While specific HIPAA details aren't explicitly stated in the search results, medical devices handling patient data are generally subject to such privacy regulations.
Reveal LINQ's AccuRhythm AI algorithms offer continuous, long-term monitoring with automated detection and classification of arrhythmias, demonstrating a significant reduction in false AF and pause alerts. This integrated system provides a comprehensive solution from data acquisition to AI-assisted interpretation, differentiating it from standalone AI analytics platforms or consumer-grade devices like smartwatches, which are limited in screening and managing chronic conditions like AF.
The cost structure for Reveal LINQ typically involves the device itself and the implantation procedure, which can be performed in an outpatient setting, potentially reducing overall costs compared to a catheterization lab. The AI's ability to reduce false positives and streamline data review can lead to more efficient diagnoses, potentially lowering downstream healthcare costs by avoiding unnecessary tests or hospitalizations.
While highly accurate, AccuRhythm AI algorithms may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system. Physicians should always use their clinical judgment to review AI-generated findings, especially when results are ambiguous or inconsistent with the patient's clinical presentation.
The AccuRhythm AI platform applies deep learning AI algorithms to Reveal LINQ ICM data flowing into the CareLinku2122 network. While specific security protocols are not detailed in the provided snippets, Medtronic emphasizes adherence to industry best practices for data security to protect sensitive patient health information.
Reveal LINQ data flows into the CareLinku2122 network, where AccuRhythm AI algorithms are applied. While the search results mention the CareLinku2122 network and mobile manager for device management, direct integration of AI-generated insights with existing EHR systems is not explicitly detailed. However, many modern medical devices and monitoring systems aim for interoperability with EHRs to streamline clinical workflows.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18