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Submissions and Approvals

Home » Topics » Medical Devices » Submissions and Approvals
  • May 25, 2022

    LumiraDx Five-Minute SARS-CoV-2 Ag Ultra Test Gains CE Mark

    The company also reported that another of its rapid COVID-19 antigen assays, the LumiraDx SARS-CoV-2 Ag Test, has received an Emergency Use Listing from the World Health Organization.
  • May 25, 2022

    RadNet Gets FDA Clearance for Mammography and Prostate AI Tools

    DeepHealth Saige-DX helps radiologists detect the presence or absence of breast cancer.
  • May 25, 2022

    Qiagen Gets CE Mark for Higher Capacity QIAstat-Dx Rise and Enhanced Test Panels

    The system can process up to 56 tests in an eight-hour shift.
Read More
  • May 25, 2022

    FDA Refuses Second Clearance to NeuroOne’s Evo sEEG Electrode

  • May 24, 2022

    Lightweight Neonatal Incubator Gets CE Mark

  • May 24, 2022

    Overjet Gets FDA Clearance for Its Caries Assist Dental AI Software

  • May 24, 2022

    Boston Scientific Receives FDA Clearance for Its Embold Fibered Detachable Coil

  • May 24, 2022

    MedMira Gets CE Mark for Its Multiplo Syphilis Antibody Test

  • May 23, 2022

    bioMérieux Gains CE Mark for its Vidas Tests for Chikungunya Virus Diagnosis

  • May 23, 2022

    Medtronic Gets Premarket Approval for its Onyx Frontier Drug-Eluting Stent

  • May 23, 2022

    Cepheid Gains Emergency Authorization for New Version of Its Xpert Xpress COVID-19 Test

  • May 23, 2022

    Becton Dickinson Gets FDA Clearance for Its Molecular Diagnostic Platform

  • May 20, 2022

    CTL Amedica’s Navigation Instrument System Cleared

Read More

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    Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

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    Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up – Webinar Recording/Transcript

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    Real-World Evidence in Medical Device Submissions: What Regulatory, Compliance & Quality Professionals Need to Know – Webinar Recording/Transcript

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    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript

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    How to Standardize your Lab Investigation Process: Increase Efficiency and Reduce Risk with a Consistent Process

  • 15Jun

    Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town

  • 22Jun

    Meet CDRH’s New Strategic Priorities: Where the Center is Headed and How Devicemakers Can Keep Up

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