Assert-IQ (DM5100)
Overview
The Assert-IQ™ Insertable Cardiac Monitor (ICM) is a medical device developed by Abbott, not a physician directory tool from a company called ‘AI Agent’. It is an innovative, Bluetooth-enabled insertable cardiac monitoring system that combines AI and IQ Insights to optimize patient management across various arrhythmia types. It is designed for continuous monitoring and automatic arrhythmia detection, enabling physicians to make more accurate and informed treatment decisions. The device is implanted subcutaneously in the left pectoral region and continuously monitors heart rhythms, transmitting data to a clinician portal via the myMerlin Mobile App on a patient’s smartphone. The Assert-IQ ICM is intended for patients experiencing unexplained symptoms associated with cardiac conditions such as dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as those at risk for or previously diagnosed with cardiac arrhythmias like atrial fibrillation (AF), bradycardia, tachycardia, and sinus pauses. It offers different battery life options, including three and six years, providing flexibility for both traditional and long-term monitoring. The system also features advanced AI algorithms that reduce false positives while maintaining high sensitivity in detecting AF and pause episodes. Remote programming capabilities allow clinicians to adjust device settings and optimize performance without requiring patient visits.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Advanced AI algorithms to reduce false positives for AF and Pause episodes
- Longest-lasting Bluetoothu00ae ICM with full functionality (up to 6 years battery life)
- Clear, crisp electrograms (EGMs) for improved visualization of P-waves
- Remote programming capabilities for device setting adjustments
- myMerlin Mobile App for patient-initiated EGM storage and data transmission
- IQ Insights for data-driven decisions with advanced diagnostics
- Body position and posture sensors
- MRI Conditional (1.5 Tesla (T) and 3T)
- Automated triggering of EGM storage for various arrhythmias
- Supports over 35 languages in the myMerlin Mobile App
Use Cases
- Monitoring and diagnostic evaluation of patients with unexplained cardiac symptoms (dizziness, palpitations, chest pain, syncope, shortness of breath)
- Monitoring patients at risk for cardiac arrhythmias (bradycardia, tachycardia, sinus pause)
- Long-term monitoring for patients previously diagnosed with atrial fibrillation (AF) or susceptible to developing AF
- Remote management and treatment of patients with irregular heartbeats
- Optimizing patient management across various arrhythmia types
- Reducing false-positive detections in cardiac monitoring
What Physicians Need to Know
Leverage the Assert-IQ's AI-powered false positive reduction to streamline data review and focus on clinically actionable AF and Pause episodes. Utilize the remote programming capabilities to customize device settings and optimize performance without requiring in-person patient visits. Pay attention to the detailed EGM visualizations and new IQ Insights, including PVC detection and body position/posture at episode onset, for a more holistic understanding of a patient's cardiac health and to inform treatment decisions, especially for patients with unexplained symptoms or those at risk for worsening heart failure.
The Assert-IQ (DM5100) seamlessly integrates with the myMerlinu2122 Mobile App and the Merlin.netu2122 Patient Care Network portal for wireless data transmission and remote patient management. The AI algorithms operate in the cloud, requiring no in-person clinical adjustments to the device itself. Remote programming capabilities allow clinicians to adjust device settings and optimize performance remotely.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing | Unknown — unknown |
| Deployment | Subcutaneously inserted device, connected to a mobile app and clinician portal. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated The Assert-IQ ICM received US FDA clearance in May 2023 for diagnostic evaluation and long-term monitoring of irregular heartbeats. In September 2025, it received 510(k) clearance for the integration of two AI algorithms based on machine learning techniques. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Critical Care, Hospital Medicine |
What the Web Says
The Assert-IQ (DM5100) is an insertable cardiac monitor (ICM) manufactured by Abbott Medical, designed for long-term ECG event monitoring. It received FDA 510(k) clearance in 2025 and is considered substantially equivalent to previous models (DM5500 and DM5000) with some modifications. The device offers automated triggering of EGM storage for various arrhythmias and allows for remote programming and patient-identified symptom logging for physician review.
Overall: MixedStrengths
- Automated EGM storage for AF, tachycardia, bradycardia, and pauses with physician-programmable values.
- Ability to inhibit EGM storage due to noise and resume detection after noise exit.
- Remote programming capability.
- Patient can identify symptoms, which are stored with the EGM for physician review.
- 4-year battery longevity, positioned between the DM5500 (6 years) and DM5000 (3 years).
- MRI Ready Manual updated to include DM5100 with no changes to scan conditions.
Limitations
- No specific cons were found in the provided search results.
- Information regarding physician, healthcare IT, tech reviewer, Reddit, G2, and Capterra reviews is limited, with most results being regulatory documents or product listings.
Based on reviews from: Abbott Medical (FDA 510(k) Premarket Notification), PW Consulting, BEUDAMED
Last updated: 2026-07-28
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