In this company spotlight, we break down the FDA 510(k) summary for Volta Medical's Volta AF-Xplorer II, cleared in September 2025. We explore how this AI tool uses deep learning to help electrophysiologists annotate 3D heart maps by analyzing intracardiac signals. Listeners will learn about its hardware requirements, catheter compatibility, algorithm updates, and the bench testing data that secured its substantial equivalence clearance.
Key points
Volta AF-Xplorer II is an AI software and computing platform cleared by the FDA to assist in real-time annotation of 3D anatomical and electrical maps during atrial fibrillation or atrial tachycardia.
The system analyzes 1.5 seconds of intra-cardiac electrogram recordings sampled at 1000Hz to detect spatiotemporal dispersion.
Updates from the predicate device include an extended training dataset, new "state of the art classifiers", and a simplified visual output that includes a gauge for dispersion stability.
The clearance is based on substantial equivalence to the original Volta AF-Xplorer, supported by unitary tests showing a 100% conformity rate and expert assessment of 2D maps in a simulated environment.
The 510(k) summary does not include new prospective clinical trial data or specify the exact numerical size of the expanded training dataset.
This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.
Podden och tillhörande omslagsbild på den här sidan tillhör
Mike Rawson. Innehållet i podden är skapat av Mike Rawson och inte av,
eller tillsammans med, Poddtoppen.
