AI system receives FDA clearance for commercial release

UK company RHYTHM AI has announced US Food and Drug Administration (FDA) 510k clearance for the commercial launch version of its lead product, STAR Apollo™ Mapping System. 

Optimising AF treatment with real time analysis of data from the LiveSync™ function of the EnSite™ X EP System (Abbott), STAR Apollo uses advanced AI driven algorithms, based on fundamental electrophysiological principles, to show repeating patterns within the arrythmia and identify regions of the heart that are potential drivers of AF. This allows the physician to create a customised treatment plan for each specific patient.

The first-in-human cases using the updated system have also been completed by Dr Mathew McKillop,

FACC, FHRS, Clinical Cardiac Electrophysiologist and Medical Director, Electrophysiology Program,  Baptist Health, Jacksonville, Florida: “STAR Apollo is allowing us to build tailored and targeted treatment strategies for this large patient group. It gives me unique insight into an individual’s AF; I’m excited to use this new technology for my patients.” 

Simon Hubbert, Chief Executive of RHYTHM AI Ltd, commented: "We are delighted to announce the FDA clearance for the live stream version of STAR Apollo Mapping. This significant milestone, alongside continued support from our investors gives us the green light to bring to market a product that will deliver significant benefits during AF ablation procedures.”

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