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Global Medical Device Regulatory, Reimbursement, and Policy Review

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Pathways' Picks

Push and Pull on EU Reforms, CDRH Guidance Priorities, and More

  • 2 days ago
  • David Filmore

In this week’s Pathways Picks: A debate over the proper speed of EU MDR/IVDR reforms; FDA’s device center issues its FY 2025 guidance priorities, and it posts new details on device trial demographics; EU and ISO actions on standards; progress toward a "breakthrough" Medicare coverage bill; Japan regulator PMDA plans to open up its first office in Washington DC; and more from FDA and the International Medical Device Regulators Forum.

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Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

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MedTech Strategist's free Community Blog explores the passion behind the people, technologies, and companies impacting the global device space.

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Regulatory & Reimbursement

Pathways' Pick of the Week: IMDRF Updates

  • 3 days ago
  • David Filmore

The International Medical Device Regulators Forum accepts new members and approves new guides. Excerpted from Pathways’ Picks October 9: TCET Tricuspid Valve Tryout, EtO Actions, IMDRF Updates, and More.

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