Electrocardiogram Devices for Home Use: Technological and Clinical Scoping Review
Bibliographic record
Abstract
BACKGROUND: Electrocardiograms (ECGs) are used by physicians to record, monitor, and diagnose the electrical activity of the heart. Recent technological advances have allowed ECG devices to move out of the clinic and into the home environment. There is a great variety of mobile ECG devices with the capabilities to be used in home environments. OBJECTIVE: This scoping review aimed to provide a comprehensive overview of the current landscape of mobile ECG devices, including the technology used, intended clinical use, and available clinical evidence. METHODS: We conducted a scoping review to identify studies concerning mobile ECG devices in the electronic database PubMed. Secondarily, an internet search was performed to identify other ECG devices available in the market. We summarized the devices' technical information and usability characteristics based on manufacturer data such as datasheets and user manuals. For each device, we searched for clinical evidence on the capabilities to record heart disorders by performing individual searches in PubMed and ClinicalTrials.gov, as well as the Food and Drug Administration (FDA) 510(k) Premarket Notification and De Novo databases. RESULTS: From the PubMed database and internet search, we identified 58 ECG devices with available manufacturer information. Technical characteristics such as shape, number of electrodes, and signal processing influence the capabilities of the devices to record cardiac disorders. Of the 58 devices, only 26 (45%) had clinical evidence available regarding their ability to detect heart disorders such as rhythm disorders, more specifically atrial fibrillation. CONCLUSIONS: ECG devices available in the market are mainly intended to be used for the detection of arrhythmias. No devices are intended to be used for the detection of other cardiac disorders. Technical and design characteristics influence the intended use of the devices and use environments. For mobile ECG devices to be intended to detect other cardiac disorders, challenges regarding signal processing and sensor characteristics should be solved to increase their detection capabilities. Devices recently released include the use of other sensors on ECG devices to increase their detection capabilities.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.045 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.017 | 0.013 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.003 | 0.001 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".