Medtronic announces regulatory milestones for newest cardiac mapping and ablation software
PR Newswire•30/09/2026•09:00 ET
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Key Highlights
- ➤Affera Prism-2 Mapping Software receives FDA clearance and CE Mark
- ➤PulseSelect ProxBox Adapter with Proximity Indicator software receives CE Mark
- ➤Prism-2 adds Beat Matching, Pace Tagging and pacing-stimulator improvements
- ➤Proximity Indicator adds real-time impedance-based tissue feedback before energy delivery
Expert Statements
Khaldoun Tarakji, MD, MPH, vice president and chief medical officer, Cardiac Ablation Solutions at Medtronic
“Innovation in mapping software is essential to realizing the full potential of cardiac ablation technologies and supporting the precision physicians seek during procedures.”
Khaldoun Tarakji, MD, MPH, vice president and chief medical officer, Cardiac Ablation Solutions at Medtronic
“We are integrating catheters, hardware and software to give physicians a more connected experience and help improve care for patients with heart rhythm disorders.”
Rebecca Seidel, senior vice president and president, Electrophysiology Therapies at Medtronic
“Software excellence is a priority across our electrophysiology business and is central to the integrated experience physicians expect.”
Rebecca Seidel, senior vice president and president, Electrophysiology Therapies at Medtronic
“These regulatory milestones advance our software capabilities alongside the continued expansion of our cardiac ablation portfolio.”
Medtronic announces regulatory milestones for newest cardiac mapping and ablation software PR Newswire
FDA clearance and CE Mark for latest Affera™ Prism-2 Mapping Software expand cardiac mapping capabilities
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