Medtronic Wins FDA Clearance, CE Mark for Affera Prism-2 Cardiac Mapping Software

Medtronic plc (MDT) said on September 30, 2026, it received FDA clearance and CE Mark for its Affera Prism-2 Mapping Software, along with a CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software. The Affera Prism-2 software enables physicians to generate three-dimensional maps of the heart's electrical activity during cardiac ablation procedures for arrhythmias. New features include Beat Matching, Pace Tagging and enhancements to the system's internal pacing stimulator. The PulseSelect ProxBox Adapter provides real-time, impedance-based feedback to help physicians assess catheter proximity to targeted heart tissue before pulsed field ablation energy is delivered. Medtronic said the regulatory milestones expand mapping and tissue-proximity capabilities across its cardiac ablation portfolio. MDT traded at $86.81, down 0.56%.