Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 24, 2026
Open Peer Review Period: Sep 25, 2026 - Nov 20, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Artificial Intelligence as a Medical Device in Cardiac Electrophysiology Across Four Regulatory Jurisdictions: Protocol for a Scoping Review
ABSTRACT
Background:
Cardiac Arrhythmias represent a growing and increasingly urgent burden on healthcare services worldwide, with an estimated 52.55 million individuals affected by atrial fibrillation and atrial flutter globally as of 2021. Artificial intelligence as a medical device (AIaMD) offers considerable promise in addressing capacity-demand pressures in cardiac electrophysiology (EP), yet existing analyses suggest that the evidence base underpinning approved devices is frequently limited in quality and transparency. No systematic characterisation of EP AIaMD across multiple international regulatory jurisdictions currently exists.
Objective:
This scoping review aims to identify regulator-approved AIaMD for cardiac electrophysiology across four jurisdictions, including the United States Food and Drug Administration (FDA), United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) Public Access Registration Database (PARD), European Database on Medical Devices (EUDAMED), and Australian Register of Therapeutic Goods (ARTG). We aim to characterise those devices and their regulatory approvals, and to report the available clinical evidence underpinning them.
Methods:
Eligible AIaMD will be identified using a snowballing approach, commencing from a curated seed list of known EP AIaMD and expanding systematically through associated product class codes and predicate devices across all four regulatory databases. PubMed, ClinicalTrials.gov, and the International Clinical Trials Registry Platform will be searched for clinical evidence underpinning each eligible device, supplemented by manufacturer website review and direct manufacturer correspondence. Two independent reviewers will conduct device registry searches and two other independent reviewers will conduct the clinical evidence search, with disagreements resolved by a third reviewer. Tables and a textual narrative will be used to synthesise findings. The protocol has been registered with the Open Science Framework (OSF) prior to data collection and will be reported in accordance with PRISMA-ScR guidelines.
Results:
Preliminary searches commenced in March 2026. Screening of regulatory device registries is currently underway. Completion of data extraction and submission for peer review is anticipated by January 2027.
Conclusions:
This protocol describes the first systematic multi-jurisdictional scoping review of AIaMD in cardiac electrophysiology. The findings will support electrophysiologists, cardiac physiologists, commissioners, and AI developers in navigating the current regulatory and evidentiary landscape and will provide a replicable methodological framework for subspecialty-level regulatory analyses across other areas of cardiology and medicine. Clinical Trial: OSF registration ID: pq6fk; https://osf.io/pq6fk/
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Copyright
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