Medtronic Announces Regulatory Milestones for Cardiac Mapping Software

Ablation Regulatory September 30, 2026

Medtronic has achieved regulatory milestones including FDA clearance and CE Mark for its Affera™ Prism-2 Mapping Software and the PulseSelect ProxBox™ Adapter with Proximity Indicator, enhancing cardiac mapping and ablation capabilities. The software assists in generating three-dimensional maps of heart electrical activity and provides real-time feedback for catheter proximity to target tissue, improving procedural precision for physicians treating heart rhythm disorders.