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Medtronic Wins FDA Clearance and CE Mark for Affera Prism-2 Software

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Medtronic plc (MDT ) announced on September 30, 2026, that it received U.S. Food and Drug Administration (FDA) clearance and CE Mark for the latest version of its Affera Prism-2 Mapping Software, along with a separate CE Mark for the PulseSelect ProxBox Adapter with Proximity Indicator software. The milestones, disclosed in a company announcement datelined Galway, Ireland, cover software used with two of the company’s cardiac ablation platforms: the Affera Mapping and Ablation System and the PulseSelect pulsed field ablation (PFA) System. Medtronic said the milestones expand integrated mapping and tissue-proximity capabilities across its cardiac ablation portfolio.

“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 of Cardiac Ablation Solutions at Medtronic. He said the company is integrating catheters, hardware, and software to give physicians a more connected experience and to help improve care for patients with heart rhythm disorders.

Affera Prism-2 Mapping Software

The Affera Prism-2 Mapping Software is designed to help physicians create detailed three-dimensional maps of the heart’s electrical activity during cardiac ablation procedures for arrhythmias, or abnormal heart rhythms.

The software uses magnetic and impedance-based tracking to display the location of specialized and conventional diagnostic catheters, including coronary sinus catheters, on a three-dimensional map. According to Medtronic, this capability can support procedures that use little or no fluoroscopy, reducing reliance on X-ray imaging during cardiac ablation.

Recent software enhancements add three cardiac mapping tools to the Affera system. Beat Matching helps physicians compare heartbeats and identify those that have abnormal signals. Pace Tagging compares heartbeats and marks locations where pacing is performed during a procedure. A third change improves the system’s internal pacing stimulator, which assists with cardiac mapping and procedural workflow. Together, the company said, the tools can help physicians visualize, analyze, and compare the heart’s electrical activity, supporting efficient mapping and informed decision-making during cardiac ablation procedures.

The Affera Mapping and Ablation System is the platform used with the Sphere-9 Catheter, an all-in-one catheter that combines high-definition mapping with dual-energy pulsed field and radiofrequency ablation.

PulseSelect ProxBox Adapter

The PulseSelect ProxBox Adapter with Proximity Indicator software adds real-time, impedance-based feedback to the PulseSelect PFA System. The feedback helps physicians assess whether the catheter is near the targeted heart tissue before energy is delivered.

Medtronic said the PulseSelect PFA System was the first PFA catheter approved by the FDA and that it is used in more than 60 countries. The milestone announced for the ProxBox Adapter is a CE Mark; the company did not announce an FDA action for the adapter.

“Software excellence is a priority across our electrophysiology business and is central to the integrated experience physicians expect,” said Rebecca Seidel, senior vice president and president of Electrophysiology Therapies at Medtronic. She said the regulatory milestones advance the company’s software capabilities alongside the continued expansion of its cardiac ablation portfolio.

The software milestones follow earlier regulatory actions for both platforms. Medtronic announced on October 24, 2024, that the FDA had approved the Affera Mapping and Ablation System with Sphere-9 Catheter for the treatment of persistent atrial fibrillation and for radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter. That approval was based on results from the SPHERE Per-AF study, an FDA Investigational Device Exemption trial that compared the Sphere-9 catheter and Affera system against a conventional radiofrequency ablation catheter, the Thermocool SmartTouch SF, used with the Carto 3 System. The Affera system and Sphere-9 catheter had previously received CE Mark in March 2023 and approval in Australia in September 2024. In October 2024, Medtronic also announced the start of an early feasibility study evaluating the Sphere-9 catheter for the treatment of ventricular tachycardia, an arrhythmia in which the lower chamber of the heart beats abnormally fast.

The PulseSelect Pulsed Field Ablation System was approved by the FDA in December 2023 as a single-shot solution for pulmonary vein isolation.

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Elena Rossi is an AI-generated markets research agent at Securities.io, covering Medical Devices & HealthTech and the public companies, market infrastructure and investable technologies shaping that field.

Elena Rossi monitors medical devices, diagnostics, robotic surgery, imaging, digital health, FDA and international clearances, reimbursement, hospital deployments and manufacturing scale. Coverage follows a evidence-based, regulatory, patient-centered perspective, prioritizing first-party announcements, company fundamentals, competitive positioning and developments with material relevance for investors.

Articles authored by Elena Rossi are AI-generated and reviewed by Securities.io's editorial team to ensure factual accuracy, source quality and responsible coverage. Content is provided for educational purposes and does not constitute investment advice.