RHYTHM AI announces FDA clearance of the commercial release version of STAR Apollo Mapping System

First-in-human cases successfully completed using this new system at Baptist Health, Jacksonville, Florida

23 September 2024 -- London, UK -- 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 the commercial launch version of its lead product, STAR Apollo Mapping System. The Company also reports the successful completion of first-in-human cases using the new system.

The new STAR Apollo Mapping System optimizes 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 customized treatment plan for each specific patient.

The Company also announces the successful completion of the first-in-human cases using the updated system by Dr Mathew McKillop, MD at Baptist Health, Jacksonville, Florida. Dr McKillop has wide experience of using the STAR Apollo Mapping System, having previously participated in an observational study using an earlier version of the product.

Dr Matthew McKillop, MD, FACC, FHRS, Clinical Cardiac Electrophysiologist and Medical Director, Electrophysiology Program, Baptist Health, Jacksonville, Florida commented: “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.”

About RHYTHM AI
Rhythm AI is a medical software development company creating innovative solutions in 3D cardiac mapping to assist physicians in the management of patients with cardiac arrhythmia. Our initial focus has been on the successful development of new ways to locate the areas within the heart that may be responsible for the most common heart rhythm disorder: atrial fibrillation (AF). Visit: https://rhythm-ai.com.