Clinical teams and regulatory specialists are taking note of an innovative clinical trial announced by Yonsei University to evaluate MEMO-Cue, a single-lead ECG patch designed for in-hospital telemetry monitoring. The trial, which is still in the preparatory recruitment phase as of December 3, 2025, aims to deliver insights into how this device may transform patient monitoring for individuals experiencing arrhythmias and other cardiac challenges.
About the Clinical Trial
The study titled “Evaluation of MEMO-Cue-Based Telemetry Monitoring” is focused on using a single-lead ECG patch for tracking various heart-related conditions in real-time. Conditions targeted include arrhythmias, atrial fibrillation, ventricular tachycardia, supraventricular tachycardia, and bradycardia. By employing MEMO-Cue technology, researchers aim to provide enhanced telemetry and patient monitoring during hospitalization.
The study connects advanced telemetry systems with crucial care requirements, empowering clinicians to detect and manage cardiac abnormalities rapidly. MEMO-Cue is introduced as a non-invasive yet sophisticated device aligned with healthcare settings.
What Makes MEMO-Cue Stand Out?
Patch Technology for High-Efficiency Data Capture
MEMO-Cue operates by providing continuous single-lead ECG data via a patch-based system. This approach minimizes the invasive procedures often associated with monitoring setups, simplifying the device application while ensuring consistent data capture. The device is optimized for acute care conditions where telemetry is essential.
Key Device Applications
The MEMO-Cue platform is tailored to address a broad spectrum of cardiac irregularities. Patients with atrial fibrillation or ventricular tachycardia can benefit from early intervention based on real-time telemetry data, leading to reduced complications during hospital stays.
Benefits in Streamlined Patient Monitoring
The MEMO-Cue system aligns closely with European Medical Device Regulation (MDR) principles, emphasizing its intended purpose as a reliable monitoring device. Studies like this trial reinforce its alignment with performance outcomes and safety measures, two pillars of regulatory compliance.
What Are the Regulatory and Clinical Implications?
The integration of telemetry devices like MEMO-Cue into hospital workflows aligns with global trends focused on improving remote and precise patient management. While the trial by Yonsei University is at an early stage, its outcomes may reshape standards for medical device usage in cardiology and related fields.
From a regulatory standpoint, MEMO-Cue’s recognition under this clinical study could open pathways to gaining national and international approvals, provided the trial supports strong efficacy and safety data. For hospitals, adopting such technologies means refining resource allocations and patient experience.
FAQ
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1. Who is conducting the study?
Yonsei University is the trial sponsor. -
2. What conditions will the device monitor?
The trial focuses on arrhythmias, atrial fibrillation, ventricular tachycardia, supraventricular tachycardia, bradycardia, and additional telemetry-focused challenges. -
3. Is the study recruiting?
No, recruitment has not yet started as of now. -
4. Why is MEMO-Cue significant?
Its patch-based design simplifies ECG collection and enhances patient monitoring accuracy.
Conclusion
As the MEMO-Cue clinical trial awaits its recruitment phase, stakeholders across clinical, regulatory, and quality teams should prepare for potential findings that could elevate the standards for in-hospital cardiac monitoring. Tracking improvements and trial results will be essential in determining its broader implementation.
Disclaimer
This article is for informational purposes only and does not constitute legal or professional advice. Readers should consult medical device regulations or legal counsel for specific guidance.
Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07260721?term=medical+device