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Submissions and Approvals

Home » Topics » Medical Devices » Submissions and Approvals
  • February 1, 2023

    Icotec Vader Pedicle System Additions Cleared

    The X-ray translucent implants expand treatment options and allow for safer tumor care, the company said.

  • February 1, 2023

    FDA Approves Axonics R20 System for Bladder and Bowel Relief

    Axonics plans on commercially launching the product in the U.S. in March.

  • February 1, 2023

    Geneoscopy Submits Premarket Application for Colorectal Screening Device

    In the 45 to 49 age group, the test demonstrated 100 percent sensitivity for cancer.

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  • January 31, 2023

    Geneoscopy Submits Premarket Application for Breakthrough Colorectal Screening Device

  • January 31, 2023

    Limbic Mental Health E-Triage Chatbot Gets UKCA Certification

  • January 31, 2023

    BioVentrix gets Expanded Access Approval for Left Ventricle Support System

  • January 30, 2023

    FDA Approves Abbott’s Spinal Cord Stimulation System for Diabetic Peripheral Neuropathy

  • January 27, 2023

    Tidepool Gains FDA Clearance for Its Crowdsourced Insulin Dosing App

  • January 27, 2023

    NeuroMetrix Launches DPNCheck 2.0 for Peripheral Neuropathy Screening

  • January 27, 2023

    Etiometry IDO2 Index Cleared for Adult Oxygen Monitoring

  • January 26, 2023

    Garmin Adds ECG App to Its Venus 2 Plus Smartwatch

  • January 26, 2023

    Tidepool Gains FDA Clearance for Its Crowdsourced Insulin Dosing App

  • January 26, 2023

    Wandercraft Walking Robotic Exoskeleton Gets FDA Clearance for Stroke Rehab

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