RCS - Rhythm AI Limited - FDA clearance for new STAR Apollo™ Mapping System

Johnson & JohnsonAnnouncement

21/01/2026 08:15

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RNS Number : 6714P  Rhythm AI Limited  21 January 2026

RHYTHM AI announces FDA clearance for new STAR Apollo(™) Mapping System

 
New system includes compatibility with CARTO™ 3 Mapping System
 
US clinical evaluations of the new system to be launched in early 2026

 

London, 21(st) 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."

 

-Ends-

 

 For further information, please contact:

 RHYTHM AI Ltd                                info@rhythm-ai.com (mailto:simon@rhythm-ai.com)

About Atrial Fibrillation

Atrial Fibrillation (AF) is the commonest abnormal heart rhythm seen in
clinical practice in which irregular electrical signals wander chaotically
throughout the upper chambers (atria) of the heart. AF affects an estimated
1.5 million in the UK and 4 to 6 million in the US alone.  The prevalence of
AF has been projected to increase to 15.9 million by the year 2050.

 

AF is associated with significant clinical morbidity and is also an
independent risk factor for mortality. Thromboembolic stroke is the most
serious and debilitating of all the complications of AF.  AF is also known to
precipitate and worsen the outcomes of congestive heart failure.

Treatment of AF, and its associated complications, increases the use of
healthcare resources and contributes to the ever-growing costs of healthcare,
particularly costs associated with hospitalizations.

 

Catheter ablation is the most common and most effective treatment for AF but
has limited success in patients with persistent AF because of the erratic
nature of AF. This makes it highly challenging to identify the exact cause or
source of the AF. This means that even in experienced hands the first-time
success rate is usually only around 50%.

 

About STAR Apollo™ Mapping System

RHYTHM AI's lead product, STAR Apollo Mapping System, transforms the treatment
of atrial fibrillation (AF) with cutting-edge, real-time data analysis from
existing electrophysiology (EP) systems. Powered by sophisticated AI
algorithms rooted in fundamental electrophysiological principles, STAR Apollo
uncovers repetitive patterns within arrhythmias and pinpoints early sites of
activation of the heart that are potential drivers of AF. This breakthrough
capability empowers physicians to craft highly personalized treatment plans
tailored to each patient's unique needs - revolutionizing how AF is diagnosed
and treated.

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