Medtronic gains regulatory wins for latest cardiac ablation software

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  "company": {
    "name": "Medtronic",
    "domain": "medtronic.com"
  },
  "data": {
    "url": "https://www.massdevice.com/medtronic-gains-regulatory-wins-for-latest-cardiac-ablation-software/",
    "title": "Medtronic gains regulatory wins for latest cardiac ablation software - massdevice.com",
    "excerpt": "Medtronic (NYSE:MDT) today announced FDA clearance and CE marks for its newest cardiac mapping and ablation software, supporting its fast-growing arrhythmia-treating cardiac ablation business. The Minnesota-run medtech secured FDA clearance and a CE mark for its Affera Prism-2 cardiac mapping software. There was also a CE mark for its PulseSelect ProxBox adapter with proximity indicator software. The regulatory wins expand integrated mapping and tissue-proximity capabilities across the Medtronic cardiac ablation portfolio, which has been a key piece of the company’s recent double-digit revenue growth. For the second quarter ended July 31, Cardiovascular sales rose 19.5% year over year to $3.927 billion (with Electrophysiology, which includes pulsed field ablation, up 29.5%). “Innovation in mapping software is essential to realizing the full potential of cardiac ablation technologies and supporting the precision physicians seek during procedures,” Dr. Khaldoun Tarakji, VP and chief medical officer of Medtronic Cardiac Ablation Solutions, said in a news release. “We are integrating catheters, hardware and software to give physicians a more connected experience and help improve care for patients with heart rhythm disorders.” The Affera Prism-2 mapping software enables electrophysiologists to create detailed three-dimensional maps of the heart’s electrical activity during cardiac...",
    "product": "Affera Prism-2",
    "summary": "Medtronic has received a CE mark for its Affera Prism-2 cardiac mapping software.",
    "location": "Minnesota, USA",
    "planning": false,
    "image_url": "https://www.massdevice.com/wp-content/uploads/2021/11/Medtronic-logo-updated.png",
    "confidence": 0.9,
    "product_data": {
      "name": "Affera Prism-2",
      "full_text": "Affera Prism-2 cardiac mapping software",
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    "product_tags": [
      "online_technology",
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    ],
    "published_at": "2026-09-30T14:21:48Z",
    "location_data": [
      {
        "state": "Minnesota",
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "article_sentence": "The Minnesota-run medtech secured FDA clearance and a CE mark for its Affera Prism-2 cardiac mapping software."
  }
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