Medtronic wins FDA clearance, CE Mark for cardiac mapping software

Medtronic (NYSE: MDT) announced 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, according to a company press release dated Sept. 30, 2026.

The Affera Prism-2 Mapping Software helps physicians create three-dimensional maps of the heart's electrical activity during cardiac ablation procedures. The software uses magnetic and impedance-based tracking to display catheter locations on a 3D map, supporting procedures that reduce reliance on X-ray imaging.

New features added to the Affera system include Beat Matching, which helps identify heartbeats with abnormal signals; Pace Tagging, which marks locations where pacing is performed; and improvements to the system's internal pacing stimulator. The Affera platform is used with the Sphere-9 Catheter, which combines mapping with pulsed field and radiofrequency ablation.

The PulseSelect ProxBox Adapter with Proximity Indicator software adds real-time, impedance-based feedback to the PulseSelect pulsed field ablation system, helping physicians assess catheter proximity to targeted tissue before energy delivery. Medtronic states the PulseSelect system was the first pulsed field ablation catheter approved by the FDA and is used in more than 60 countries.

"Innovation in mapping software is essential to realizing the full potential of cardiac ablation technologies and supporting the precision physicians seek during procedures," said Khaldoun Tarakji, MD, MPH, vice president and chief medical officer, Cardiac Ablation Solutions at Medtronic.

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