Medtronic Secures US and EU Regulatory Approvals for Cardiac Mapping Tech

Key Facts

1Medtronic received FDA clearance and CE Mark for its Affera Prism-2 cardiac mapping software.

2The PulseSelect ProxBox Adapter received a CE Mark, providing real-time tissue proximity feedback during procedures.

Medtronic received FDA clearance and the CE Mark for its Affera Prism-2 cardiac mapping software. PR Newswire reported that the company also obtained the CE Mark for the PulseSelect ProxBox adapter, which provides real-time tissue proximity feedback during medical procedures. These technologies are designed to create detailed three-dimensional maps of cardiac electrical activity to support precision in treating arrhythmias.

MDT closed at $87.09 on September 29, 2026, after reaching a session high of $89.22. These regulatory milestones strengthen the company's PulseSelect platform as Medtronic expands its capabilities in integrating advanced mapping software with pulsed field and radiofrequency ablation technologies.