The Investor
30 Sep 2026, 18:29
Medtronic Gains Regulatory Clearances for New Cardiac Mapping and Ablation Software
Medtronic announced new regulatory milestones for software used across its cardiac ablation portfolio, including FDA clearance and CE Mark for the latest Affera Prism-2 Mapping Software.
The Prism-2 software is designed to support detailed three-dimensional mapping of the heart’s electrical activity during ablation procedures. It uses magnetic and impedance-based tracking to display catheter locations and can support procedures performed with little or no fluoroscopy, potentially reducing reliance on X-ray imaging.
The latest software adds new mapping tools including Beat Matching, Pace Tagging and enhancements to the system’s internal pacing stimulator. These features are intended to help physicians compare heartbeats, identify abnormal electrical signals and improve procedural workflow.
The Affera system is used with Medtronic’s Sphere-9 catheter, which combines high-definition mapping with both pulsed field and radiofrequency ablation.
Medtronic also received CE Mark for its PulseSelect ProxBox Adapter with Proximity Indicator software. The system provides real-time, impedance-based feedback to help physicians determine whether the catheter is close to targeted heart tissue before energy delivery.
The regulatory milestones strengthen Medtronic’s electrophysiology portfolio by expanding software-driven mapping and tissue-proximity capabilities across two of its cardiac ablation platforms.
Medtronic announced new regulatory milestones for software used across its cardiac ablation portfolio, including FDA clearance and CE Mark for the latest Affera Prism-2 Mapping Software.
The Prism-2 software is designed to support detailed three-dimensional mapping of the heart’s electrical activity during ablation procedures. It uses magnetic and impedance-based tracking to display catheter locations and can support procedures performed with little or no fluoroscopy, potentially reducing reliance on X-ray imaging.
The latest software adds new mapping tools including Beat Matching, Pace Tagging and enhancements to the system’s internal pacing stimulator. These features are intended to help physicians compare heartbeats, identify abnormal electrical signals and improve procedural workflow.
The Affera system is used with Medtronic’s Sphere-9 catheter, which combines high-definition mapping with both pulsed field and radiofrequency ablation.
Medtronic also received CE Mark for its PulseSelect ProxBox Adapter with Proximity Indicator software. The system provides real-time, impedance-based feedback to help physicians determine whether the catheter is close to targeted heart tissue before energy delivery.
The regulatory milestones strengthen Medtronic’s electrophysiology portfolio by expanding software-driven mapping and tissue-proximity capabilities across two of its cardiac ablation platforms.
