LINQ II Insertable Cardiac Monitor

The LINQ II Insertable Cardiac Monitor (Model LNQ22) is designed for long-term subcutaneous ECG monitoring to automatically detect and record arrhythmias, as well as enable patient-activated recordings, in both adult and pediatric patients (≥2 years) at risk or symptomatic for cardiac rhythm disturbances. It utilizes a sapphire-based hermetic enclosure, titanium nitride-coated electrodes, and AI-assisted ECG classification, with recent updates extending its use to younger patients and broader MRI conditions.

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device designed for continuous monitoring of a patient's subcutaneous ECG and other physiological parameters. Its primary purpose is to record cardiac information automatically upon detection of arrhythmias (such as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation) or when manually activated by the patient. Patient-initiated recording is facilitated by the MyCareLink Heart App on a mobile device or the Patient Assistant Model PA97000, allowing users to capture their cardiac rhythm during or immediately after symptomatic events like dizziness, palpitation, syncope, or chest pain. The device is indicated for adult patients and pediatric patients (at least 2 years old) who have clinical syndromes or situations at increased risk of cardiac arrhythmias, or who experience transient symptoms suggestive of a cardiac arrhythmia. The LINQ II ICM features a small form factor with a hybrid substrate made of sapphire, which forms part of its hermetic enclosure and integrates feedthroughs. Its antenna and sense electrodes are titanium foil laser-bonded to the sapphire, with the sense electrodes coated in sputtered titanium nitride. The device is powered by a Lithium anode, silver vanadium oxide/carbon monofluoride cathode battery (167 mAh) and utilizes body-contacting materials such as Sapphire, Titanium, and Parylene. Key updates described in this submission include extending the indications for use to the pediatric population (2 years and older) and expanding the MRI conditions for use from static magnetic fields of 1.5 T or 3.0 T to static magnetic fields of ≤ 3 T. Associated medical accessories include the LINQ Tool Kit, Patient Assistant, Reveal LINQ™ Mobile Manager, Device Command Library, Instrument Command Library, and the Zelda (AccuRhythm) AI ECG Classification System.

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 "other physiological parameters" besides ECG does the LINQ II ICM continuously monitor, and how does the Zelda (AccuRhythm) AI ECG Classification System enhance arrhythmia detection accuracy compared to previous algorithms?; What were the key findings from the retrospective clinical evaluation that supported the safety and effectiveness for pediatric use, particularly for patients as young as 2 years old, considering anatomical and physiological differences?; How does the device's performance, specifically sensitivity and specificity for arrhythmia detection, vary between adult and pediatric populations, and are there different algorithmic thresholds or considerations for pediatric patients?; What are the practical implications and potential challenges of expanding MRI compatibility to "static magnetic fields of ≤ 3 T" for patients with the LINQ II ICM, particularly regarding image artifact or device heating?; What is the typical battery longevity of the LINQ II ICM (167 mAh) under various usage conditions (e.g., frequency of automatic detections, patient activations, and data transmissions), and how does this compare to its predicate device?