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Germany is adjusting the national COVID-19 testing strategy, which from mid-October will include the use of antigen tests.

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Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.

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COVID-19 Testing Boosts Roche Diagnostics Sales In H1

Roche's diagnostics division grew 3% in the first half of 2020 with exploding demand for COVID-19 tests offsetting declines in routine testing.

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The diagnostics industry could benefit from a greater focus on real-world evidence linked to the COVID-19 pandemic, according to experts from the US FDA and industry.

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Company Information

  • Industry
  • Medical Devices
  • Pharmaceuticals
  • Pharmaceuticals
    • OTC, Consumer
  • Medical Devices
    • Consumables, Central Supplies
    • Diagnostic Imaging Equipment & Supplies
      • X-ray
  • Other Names / Subsidiaries
    • 3M Company
    • Acelity L.P. Inc.
    • Crawford Healthcare Holdings Limited
    • Kinetic Concepts, Inc.
    • M*Modal
    • Minnesota Mining and Manufacturing
    • Scott Safety
    • Semfinder
    • Systagenix Wound Management, Limited
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