AT-Patch (ATP-C130/ATP-C70)

The AT-Patch system is a wearable electrocardiogram (ECG) device designed to non-invasively capture and analyze continuous cardiac electrical activity for extended periods, aiming to detect and report arrhythmias in adult patients experiencing or at risk of cardiac symptoms. Its methodology involves automated algorithmic analysis followed by crucial clinician review, ensuring diagnostic accuracy while relying on a robust platform validated through comprehensive non-clinical performance and substantial equivalence testing.

The AT-Patch system by ATsens Co., Ltd. is a wearable device designed for the capture, analysis, and reporting of continuous electrocardiogram (ECG) information. Comprising an ECG recorder (ATP-C130/ATP-C70), analysis software (AT-Report), and a viewer (AT-Note), it attaches to the patient's torso for extended recording periods, up to 14 days. It is indicated for adult patients (18+) with symptoms like palpitations or dizziness, or those who are asymptomatic, but it is not intended for real-time patient monitoring. Data from the AT-Patch is primarily analyzed by algorithms in the AT-Report software, followed by essential secondary review and correction by a clinician. The system underwent extensive non-clinical performance tests, including electrical safety, electromagnetic compatibility, biocompatibility, and software validation. Based on a thorough comparison with existing devices, the AT-Patch system was found to be substantially equivalent for its specified indications for use, confirming its readiness for clinical application.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific arrhythmias or cardiac events can the AT-Patch system reliably detect, and how does its sensitivity and specificity compare to traditional Holter monitors or other long-term ECG recorders?; Given that the system is not for real-time monitoring, what is the typical turnaround time for clinician review and diagnosis after data transfer, and how does this impact acute patient management?; What are the limitations of the primary algorithm-based analysis, and what is the inter-rater variability or accuracy gain achieved through secondary clinician review and correction?; How robust is the data integrity and transmission process, especially over extended recording periods and given potential patient activities, to ensure reliable data capture?; Are there any post-market surveillance data or clinical studies demonstrating the long-term clinical utility, patient compliance, or impact on patient outcomes for this device?