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FDA Breakthrough Device Designation

  • Biotech & Pharma Business,Clinical & Regulatory,Medical devices,Research & Development

    En Carta Diagnostics secures €5M to advance at-home molecular testing

    En Carta Diagnostics has raised €5 million to support regulatory [...]

    July 13, 2026
  • Clinical & Regulatory,Medical devices,Research & Development

    Xeltis passes halfway mark in US trial of haemodialysis vascular access device

    Xeltis has passed the halfway enrolment mark in its US [...]

    July 3, 2026
  • Digital & Data,Drug Discovery & Development,Medical devices,Therapeutic Areas

    En Carta Diagnostics receives FDA breakthrough device designation for Lyme disease test

    En Carta Diagnostics has received FDA Breakthrough Device Designation for [...]

    May 5, 2026

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