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De Novo authorisation

  • Clinical & Regulatory,Medical devices,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA grants De Novo authorisation to Avulux migraine light-sensitivity lens

    The FDA has granted De Novo marketing authorisation to Avulux, [...]

    August 24, 2026
  • Clinical & Regulatory,Digital & Data,Medical devices,Research & Development

    Caristo Diagnostics’ CaRi-Heart coronary inflammation technology authorised by US FDA

    Caristo Diagnostics’ CaRi-Heart technology has received US FDA De Novo [...]

    July 30, 2026

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