ICM EGM Triage Using Machine Learning for False Positive Filtering

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Solution Overview

Problem

Existing implantable cardiac monitors (ICMs) face challenges in managing large volumes of electrogram (EGM) data, including false arrhythmia detections that burden clinicians with manual review and introduce inaccuracies in diagnostic information due to false positives, particularly from conditions like sick sinus rhythms and premature ventricular contractions.

Innovation Solution

A system utilizing machine-learning models to analyze classified EGM datasets from ICMs, determining confidence indicators, ranking scores, and selecting a subset of EGM datasets for display, thereby reducing clinical review burden and improving diagnostic accuracy by mitigating false positives.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If all EGM segments are reviewed manually, then diagnostic accuracy is maintained, but clinical workload and resource requirements increase significantly

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidclinical workload
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent extracts and separates EGM segments into distinct categories based on arrhythmia detection confidence levels. High-confidence segments are isolated for automated processing while low-confidence segments remain for manual review, thereby reducing clinical workload while maintaining diagnostic accuracy for critical cases.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an intermediary machine-learning classification system that acts between the EGM data and clinical reviewers. This intermediary automatically prioritizes and filters segments, presenting only the most relevant data to clinicians and reducing the time and resources required for manual review.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If EGM data volume is reduced, then clinical review time decreases, but false arrhythmia detections increase

Engineering Contradiction:
Improveclinical review timeVSAvoidfalse arrhythmia detection rate
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent applies local quality by differentiating EGM segments based on their individual confidence levels. Each segment is evaluated and assigned a priority level, allowing clinicians to focus manual review on low-confidence segments that may represent false detections, while high-confidence segments are processed automatically, thus reducing review time without increasing false detection rates.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent performs preliminary action by using machine-learning models to pre-classify and prioritize EGM segments before they reach clinical reviewers. This preliminary processing filters out obvious false detections and organizes data by urgency and relevance, allowing clinicians to review only the most critical segments efficiently.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If machine-learning models are applied to filter EGM data, then clinical review burden decreases, but system complexity increases

Engineering Contradiction:
Improveclinical review burdenVSAvoidsystem complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent implements self-service by enabling the machine-learning system to autonomously classify, prioritize, and filter EGM segments without requiring continuous human intervention. The system self-adjusts and processes data independently, reducing clinical review burden while the complexity is contained within the automated infrastructure rather than requiring manual management.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS20260033789A1Implantable medical device data and diagnostics management system and method using machine-learning architecture
Publication Date: 2026.02.05 PACESETTER INC
  • US20260033789A1 patent drawing
  • US20260033789A1 patent drawing
  • US20260033789A1 patent drawing

AI summary

A medical data and diagnostics management system for processing classified EGM datasets includes a server system that receives transmissions of classified EGM datasets, each corresponding to an arrhythmic episode detected by an IMD, and applies a machine-learning model to each classified EGM dataset stored in a database, thereby determining for each of the classified EGM datasets to which the model is applied a respective indicator of whether the IMD classification is a false positive or a true positive. The system is further configured to remove from the database one or more of the classified EGM data sets for which the respective IMD classification is identified using the machine-learning model as being a false positive, thereby creating a plurality of machine-adjudicated patient database records stored in the database. The system may also provide for display a selected one of the machine-adjudicated EGM datasets and/or facilitate reprograming the IMD.