New system includes compatibility with CARTO™ 3 Mapping System
US clinical evaluations of the new system to be launched in early 2026
London, 21st January 2026: RHYTHM AI Ltd (“RHYTHM AI” or “the Company”), a UK company focused on optimizing atrial fibrillation (AF) procedures, announces US Food and Drug Administration (FDA) 510k clearance for its new STAR Apollo Mapping System, which expands compatibility to include CARTO™ 3 Mapping System from Johnson & Johnson MedTech.
The new STAR Apollo Mapping System optimizes AF procedures with real time analysis of data from the live data transfer function of the CARTO System. STAR Apollo uses advanced AI driven algorithms to show repeating patterns of activation within the atria and identify regions of the heart that are potential drivers of AF. This allows the physician to create a customized treatment plan for each specific patient.
Following the FDA clearance, the Company plans a limited market release of the new STAR Apollo Mapping System with CARTO live data transfer in the US in early 2026.
Simon Hubbert, Chief Executive Officer of RHYTHM AI, commented: “We are delighted to announce the latest FDA clearance for the STAR Apollo Mapping System, broadening compatibility to include the CARTO 3 Mapping System from Johnson & Johnson MedTech, the global market leader in cardiac arrhythmia treatment. We believe that combining STAR Apollo mapping with CARTO live data streaming will deliver significant benefits to physicians and patients during AF ablation procedures, while also allowing us to expand patient reach.”