Rhythm AI’s STAR Apollo system receives FDA clearance for atrial fibrillation
pharmafile | February 12, 2026 | News story | Research and Development | Cardiology, Rhythm AI, atrial fibrillation
Rhythm AI, a UK-based company specialising in atrial fibrillation procedures, has announced that its STAR Apollo Mapping System has received 510k clearance from the US Food and Drug Administration (FDA) for use in atrial fibrillation (AF).
The STAR Apollo Mapping System now has increased compatibility, which includes Johnson & Johnson’s CARTO 3 Mapping System. It analyses data from the CARTO System’s live data transfer capability in real time, using AI-based algorithms to identify heart regions associated with AF and repeating patterns in the heart’s atria. This enables optimisation of AF procedures and allows for the creation of personalised treatment for individual patients.
AF is the most common abnormal heart rhythm observed by doctors. It is caused by irregular electrical signals in the upper chambers, or atria, of the heart, and affects around 1.5 million people in the UK and four to six million people in the US. Estimates predict that AF will reach a patient population of 15.9 million people by 2050.
As well as being associated with mortality risks, AF comes with many possible serious complications. One of the most major is thromboembolic stroke. The outcomes of congestive heart failure have also been observed to be precipitated and worsened by AF. Additionally, AF places a consistent financial strain on healthcare systems, due to the difficulty of identifying its cause and the resistance some patients have to treatment.
A limited market release of the STAR Apollo Mapping System has been planned by Rhythm AI for early 2026.
Simon Hubbert, CEO of Rhythm AI, said: “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.”
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