Assert-IQ

by Abbott Medical  · Based in United States → — Advanced, long-term insertable cardiac monitoring for comprehensive arrhythmia detection.
Cardiology Internal Medicine

Enterprise
Documentation ProvidedRegulatory Status Disclosed

Overview

The Assert-IQ™ Insertable Cardiac Monitor (ICM) system from Abbott Medical represents a significant advancement in the long-term, continuous monitoring of patients suspected of having cardiac arrhythmias or experiencing unexplained syncope. Designed with the physician in mind, this minimally invasive device provides critical diagnostic data over an extended period, aiding in the timely and accurate identification of elusive heart rhythm disorders. Its robust capabilities aim to enhance diagnostic yield and streamline patient management pathways.

At its core, the Assert-IQ™ ICM system offers continuous cardiac monitoring for up to six years, a duration that significantly increases the likelihood of capturing infrequent arrhythmic events. The device employs sophisticated algorithms to detect and classify various abnormal heart rhythms, including atrial fibrillation, bradycardia, and tachycardia. Data is seamlessly transmitted via Bluetooth® Low Energy technology from the ICM to a secure, cloud-based platform, which clinicians can access remotely for comprehensive review and analysis. A dedicated patient activator allows individuals to log symptoms, correlating them with recorded cardiac events.

For physicians, the Assert-IQ™ system translates into improved diagnostic efficiency and enhanced patient care. The remote monitoring feature reduces the need for frequent in-person visits, while proactive alerts notify clinicians of critical events, enabling prompt intervention. This comprehensive data access and intelligent event detection empower cardiologists and electrophysiologists to make more informed clinical decisions, optimize treatment strategies, and ultimately improve patient outcomes by providing a clearer picture of their cardiac health over time.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Long-term continuous cardiac monitoring (up to 6 years)
  • Advanced arrhythmia detection algorithms
  • Bluetoothu00ae Low Energy data transmission
  • Secure cloud-based data platform
  • Remote monitoring capabilities
  • Proactive clinician alerts
  • Patient activator for symptom logging
  • Minimally invasive insertion

Use Cases

  • Diagnosis of unexplained syncope
  • Detection of suspected atrial fibrillation
  • Monitoring for other cardiac arrhythmias (bradycardia, tachycardia)
  • Post-stroke arrhythmia detection
  • Evaluation of cryptogenic stroke

What Physicians Need to Know

ECG/EKG Analysis Capability
Assert-IQ is an Insertable Cardiac Monitor (ICM) that records clear, crisp Electrograms (EGMs) for improved visualization of P-waves. It utilizes advanced algorithms to analyze heart rhythms, focusing on R-R interval patterns and P-waves for accurate detection.
Arrhythmia Detection Accuracy
Advanced AI algorithms significantly reduce false positives for Atrial Fibrillation (AF) and Pause episodes while maintaining high sensitivity. Studies show 99.4% episode-based AF sensitivity compared to Holter monitoring, with AI retaining all true episodes. AI reduces false Pause episodes by up to 90% and false AF episodes by 81%, maintaining 100% patient sensitivity for pause and AF. It achieves a 94% positive predictive value for AF episodes and reduces false detections by 98.7% for AF and Pause while maintaining 97.7% of true EGMs. The system also features a leading PVC detection algorithm that captures consecutive events, including couplets and triplets.
Cardiac Monitoring Integration
Assert-IQ is a continuous, long-term Insertable Cardiac Monitor (ICM) system. It uses Bluetoothu00ae technology to connect to a patient's cell phone, which acts as a transmitter, sending real-time results to the Merlin.netu2122 Patient Care Network (PCN). The system offers remote programmability, allowing clinicians to adjust device settings without requiring a clinic visit. It provides 'IQ Insights' for a holistic view of cardiovascular health, including trends and timelines for AF Burden, PVCs, and Activity Trends. Assert-IQ ICM is available with battery life options of 3+ and 6+ years.
AHA/ACC Guideline Alignment
Long-term monitoring with an ICM, such as Assert-IQ, is supported by professional societies and aligns with guidelines like the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation, particularly for AF management and post-ablation patients.
Real-Time Alert Capability
The Assert-IQ ICM checks heart rhythms every 20 seconds and transmits findings in real-time to the clinic's portal. Its cloud-based AI algorithms detect and classify AFib in near-real time. The AI filters data to present only 'true' AFib episodes, reducing data burden and enabling clinicians to prioritize actionable information. Mobile DirectAlertsu2122 are also part of the Merlin.net Patient Care Network.
Physician Tip

Leverage Assert-IQ's advanced AI to significantly reduce false positive alerts, streamlining data review and improving clinic efficiency. Utilize the long-lasting battery and remote programmability for extended patient monitoring and convenience, minimizing in-person visits. Pay close attention to the clear EGMs for enhanced P-wave visualization, aiding in faster and more informed clinical decisions. Employ the 'Key Episode' technology for tailored arrhythmia management and the IQ Insights for comprehensive trends in AF burden, PVCs, and activity levels to guide treatment strategies. While Assert-IQ monitors PVCs that can be associated with heart failure, consider it primarily for arrhythmia detection and management.

Assert-IQ seamlessly integrates with Abbott's Merlin.netu2122 Patient Care Network (PCN) and the myMerlinu2122 Mobile App via Bluetoothu00ae technology for continuous data transmission and remote patient management. This connectivity facilitates real-time data access, remote programming of the device, and the delivery of mobile DirectAlertsu2122 to optimize workflow and patient care.

Details

Category Cardiology AI, Clinical Decision Support & Reference
Pricing Enterprise — Contact Abbott Medical for institutional pricing.
Free Trial No
DeploymentHybrid
Mobile AppNone
API Available No
Data Export Yes
LanguagesEnglish
Training Yes
Target SizeLarge health systems, hospitals, cardiology clinics
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated — 510(k) K253516, cleared 12/18/2023
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine

Support & Reliability

Training Provided Yes

What the Web Says

Assert-IQ is a next-generation insertable cardiac monitor (ICM) from Abbott designed for long-term, continuous heart monitoring. It aims to provide accurate and timely detection of arrhythmias, offering a streamlined workflow for physicians and a less intrusive experience for patients. Reviews highlight its advanced algorithms and connectivity features.

Overall: Positive

Strengths

  • Long battery life (up to 5.5 years) reduces need for frequent device replacements.
  • Advanced algorithms for accurate arrhythmia detection and reduced false positives.
  • Smartphone connectivity for easy data transmission and patient engagement.
  • Small size and minimally invasive insertion procedure.
  • Streamlined data management and reporting for clinicians.
  • Remote monitoring capabilities improve patient convenience and clinical oversight.

Limitations

  • Potential for connectivity issues or user error with smartphone app.
  • Learning curve for new software and data interpretation for some clinicians.
  • Cost of the device and associated monitoring services can be a factor.
  • Data overload for clinicians if not managed effectively.
  • Patient compliance with daily data transmission can vary.
  • Limited direct physician reviews available publicly on some platforms.

Based on reviews from: Abbott Website, Cardiology Today, EP Lab Digest, Reddit (r/cardiology, r/medtech), Healthcare IT News, Medical Device Network

Last updated: 2026-07-17

Ratings & Reviews

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Ease of Use
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Press & Coverage

PR Newswire
Abbott Receives FDA Clearance for Assert-IQu2122 Insertable Cardiac Monitor to Help Doctors Monitor People's Heart Rhythms Long-Term
Abbott announced that its Assert-IQu2122 insertable cardiac monitor (ICM) received U.S. Food and Drug Administration (FDA) clearance, providing physicians with a new option for diagnostic evaluation and long-term monitoring of irregular heartbeats. This device offers the world's longest battery life for an ICM, with options for at least three or six years of use.
2023-05
Pharmafocus
FDA approves Abbott's Assert-IQ insertable cardiac monitor
The FDA has cleared Abbott's Assert-IQ insertable cardiac monitor (ICM), offering doctors a new diagnostic and long-term monitoring solution for irregular heartbeats. The device features two battery life options (three or six years) and uses Bluetooth to transmit heart rhythm data in real-time to a clinic's portal.
2023-05
Abbott MediaRoom
Abbott Receives CE Mark for its Groundbreaking Assert-IQu2122 Insertable Cardiac Monitor, Expanding Availability of Long-Term Monitoring for Irregular Heart Rhythms
Abbott announced it has received CE Mark in Europe for its Assert-IQu2122 insertable cardiac monitor (ICM), providing physicians with a new option for diagnostic evaluation and long-term monitoring of people experiencing abnormal heartbeats. The Assert-IQ ICM offers the world's longest battery life for a Bluetooth-enabled ICM, with options for at least three or six years.
2024-03
Cardiac Rhythm News
Assert-IQ insertable cardiac monitor gains CE mark
Abbott has received CE mark in Europe for its Assert-IQ insertable cardiac monitor (ICM), which continuously monitors heart rhythms and detects arrhythmias. The device offers industry-leading battery life options of at least three or six years and utilizes advanced algorithms to reduce data burden and increase accuracy.
2024-03
BioWorld
Abbott secures CE mark for Assert-IQ insertable cardiac monitor
Abbott Laboratories has secured CE mark for two versions of its Assert-IQ insertable cardiac monitor (ICM), offering three-year and six-year battery life options. This device is designed for long-term remote monitoring of individuals with abnormal heartbeats or those at risk of developing arrhythmias.
2024-03
Abbott Cardiovascular
An Inside Look at Assert-IQu2122 ICM, Powered by AI
Abbott's Assert-IQu2122 Insertable Cardiac Monitor (ICM) is leveraging new AI technology for accurate arrhythmia classification. The AI algorithms, which are neural networks trained on thousands of electrograms, aim to reduce false positives and provide more actionable notifications for healthcare providers.
2026-02
PMC (PubMed Central)
Atrial fibrillation detection performance of an insertable cardiac monitor: Results from an Assert-IQ post-market clinical study and a novel artificial intelligence algorithm
This study evaluated the Assert-IQ ICM's performance in detecting atrial fibrillation (AF) and the impact of an AI algorithm designed to reduce false positives. The Assert-IQ ICM demonstrated high sensitivity in detecting AF, and the AI algorithm significantly reduced false-positive AF episodes while preserving sensitivity.
2026-06
PMC (PubMed Central)
Evaluation of Paroxysmal Atrial Fibrillation Detection Using Short-Term Monitoring With an Insertable Cardiac Monitor in Patients With Cryptogenic Stroke: Initial Clinical Results
This article presents initial clinical results on the use of the Assert-IQ ICM for short-term monitoring in patients with cryptogenic stroke to detect paroxysmal atrial fibrillation (PAF). The study found that short-term ICM monitoring aided in PAF detection and potentially reduced the analytical workload for healthcare professionals.
2025-08

Videos

Product demos, reviews, and walkthroughs for Assert-IQ.

View all on YouTube

Frequently Asked Questions

Assert-IQ utilizes advanced AI algorithms to enhance the accuracy of arrhythmia detection, specifically reducing false positives for Atrial Fibrillation (AF) and Pause episodes while maintaining high sensitivity. This AI-powered system is primarily indicated for monitoring and diagnostic evaluation of patients experiencing unexplained cardiac-related symptoms like dizziness, palpitations, syncope, and shortness of breath, as well as those at risk for or previously diagnosed with AF.
Assert-IQ employs Bluetoothu00ae Low Energy (BLE) technology to capture, encrypt, and securely transfer patient data to the Merlin.netu2122 Patient Care Network (PCN). Abbott's SyncUPu2122 Remote Monitoring Support team also provides personalized education to patients on app usage and remote monitoring, aiming to ensure consistent and secure data transmission.
Assert-IQ is noted for combining AI with the longest-lasting Bluetoothu00ae ICM, offering battery life options of at least three or six years, which is longer than many rival devices. Its AI algorithms are designed to significantly reduce false positives and data burden, a key differentiator in comparison to other ICMs.
While specific pricing is not publicly detailed, Abbott provides resources for healthcare professionals regarding reimbursement and coding for Assert-IQ. This information is typically available through their sales representatives or dedicated sections on their professional website to help clinics understand the financial aspects of integrating the device.
Assert-IQ has not been specifically tested for pediatric use. Potential adverse events, though rare, can include allergic reaction, bleeding, infection, hematoma formation, and device migration. Physicians should refer to the user manual for detailed indications for use, contraindications, warnings, precautions, and potential adverse events.
Assert-IQ is designed to streamline clinical workflows by leveraging AI to filter data and reduce false positives, which can save clinics significant time annually. It also offers remote programmability, allowing clinicians to adjust device settings without requiring in-person patient visits, further reducing workflow burden.
Assert-IQ offers secure remote programming capabilities, allowing clinicians to adjust device parameters, optimize performance, and limit unnecessary alerts or transmissions. This feature enhances workflow flexibility, reduces the need for patients to visit the clinic for device adjustments, and ensures transmitted data remains relevant to the patient's condition.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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