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Medical equipment industry

EP MedSystems Receives Regulatory Approval for Integrated Electrophysiology Recording System

Strategic Insights

— 1 min read

EP MedSystems, a developer of electrophysiology products, has received regulatory approval from the European Notified Body for its integration of Boston Scientific Corp.'s RPM Real-time Position Management technology with its EP-WorkMate workstation. This approval enables the company to sell the product within the European Community, comprising 15 countries. The EP-WorkMate with RPM is a comprehensive electrophysiology recording system that integrates advanced recording and stimulation, anatomic modeling, advanced mapping, and 3-D navigation features, enhancing the efficiency and user-friendliness of electrophysiologic studies.

Key Takeaways:

  • EP MedSystems has received regulatory approval from the European Notified Body for its integration of Boston Scientific Corp.'s RPM technology with its EP-WorkMate workstation.
  • The approval allows the company to affix the CE mark on the product, enabling its sale within the 15 countries of the European Community.
  • The EP-WorkMate with RPM is a comprehensive electrophysiology recording system that integrates advanced recording and stimulation, anatomic modeling, advanced mapping, and 3-D navigation features.
  • This system provides electrophysiologic studies with enhanced efficiency and user-friendliness.
  • Reinhard Schmidt, president and CEO of EP MedSystems, noted that the approval is a significant milestone for the company, continuing its rollout of new products into the marketplace.
  • The company has seen a strong response from the marketplace in the United States for its new EP WorkMate with RPM offering.
  • Schmidt also mentioned that the RPM upgrade provides an easy and cost-effective way for the installed base to participate in the market trend toward anatomical modeling, advanced mapping, and 3-D navigation for complex ablation procedures.
  • International expansion is a key driver of future growth for EP MedSystems, with this approval being a successful step in the company's growth strategy.
  • The joint-development project with the electrophysiology business unit of Boston Scientific Corp. has culminated in the EP-WorkMate with RPM integrated EP recording and navigation system.

Statistics:

  • The EP-WorkMate with RPM system is currently the only electrophysiology recording system available on the market with integrated advanced recording and stimulation, anatomic modeling, advanced mapping, and 3-D navigation features.
  • The system has been developed through a joint-project with the electrophysiology business unit of Boston Scientific Corp.
  • The approval received will enable EP MedSystems to sell the product within the 15 countries of the European Community.

Sources:

  • (NewsRx.com & NewsRx.net)
  • News Release: "EP MedSystems Announces Regulatory Approval of Integrated Electrophysiology Recording System"

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