Medtronic gains cardiac-software clearances across two ablation platforms

Medtronic ($MDT) obtained FDA clearance and a European CE mark for its latest Affera Prism-2 cardiac mapping software, alongside a CE mark for the PulseSelect ProxBox adapter and Proximity Indicator software. The Affera upgrade adds tools for comparing electrical signals and marking pacing locations, while supporting three-dimensional visualization of diagnostic catheters during procedures for abnormal heart rhythms.

The PulseSelect addition provides real-time, impedance-based information about catheter proximity to targeted tissue before ablation energy is delivered. Together, the changes broaden the company’s integrated electrophysiology offering and may improve procedural workflows. The authorizations are not identical: the announced US clearance concerns Affera, while the new PulseSelect adapter milestone is European. Medtronic did not quantify incremental sales or demonstrate a new clinical-outcome benefit in this announcement.

Sources:

• Company release via PR Newswire