Medtronic secures FDA clearance and CE Mark for Prism-2 software

Medtronic announced on September 30, 2026, regulatory milestones across its cardiac ablation portfolio. The company secured U.S. Food and Drug Administration clearance and CE Mark for its latest Affera Prism-2 Mapping Software. In addition, Medtronic obtained CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software.

The Affera Prism-2 software creates three-dimensional maps of electrical activity during cardiac ablation for arrhythmias. It employs magnetic and impedance-based tracking to display catheters, including coronary sinus catheters, reducing procedural reliance on X-ray imaging. New features include Beat Matching to identify abnormal signals, Pace Tagging to mark pacing locations, and improvements to the internal pacing stimulator. The Affera platform operates with the Sphere-9 Catheter, which combines mapping with pulsed field and radiofrequency ablation.

The PulseSelect ProxBox Adapter adds real-time, impedance-based proximity feedback to the PulseSelect pulsed field ablation system before energy delivery. The PulseSelect platform was the first pulsed field ablation catheter approved by the FDA and is currently used in more than 60 countries.

Rebecca Seidel, senior vice president and president of Electrophysiology Therapies at Medtronic, noted that software excellence is central to the integrated experience physicians expect across electrophysiology procedures.