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Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives.
Fraser, Alan G; Biasin, Elisabetta; Bijnens, Bart; Bruining, Nico; Caiani, Enrico G; Cobbaert, Koen; Davies, Rhodri H; Gilbert, Stephen H; Hovestadt, Leo; Kamenjasevic, Erik; Kwade, Zuzanna; McGauran, Gearóid; O'Connor, Gearóid; Vasey, Baptiste; Rademakers, Frank E.
Afiliación
  • Fraser AG; University Hospital of Wales, School of Medicine, Cardiff University, Heath Park, Cardiff, U.K.
  • Biasin E; KU Leuven, Leuven, Belgium.
  • Bijnens B; Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium.
  • Bruining N; Engineering Sciences, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
  • Caiani EG; Department of Clinical and Experimental Information processing (Digital Cardiology), Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands.
  • Cobbaert K; Department of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, Italy.
  • Davies RH; Philips, Brussels, Belgium.
  • Gilbert SH; Institute of Cardiovascular Science, University College London, London, U.K.
  • Hovestadt L; Technische Universität Dresden, Else Kröner Fresenius Center for Digital Health, Dresden, Germany.
  • Kamenjasevic E; Elekta, Stockholm, Sweden.
  • Kwade Z; Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium.
  • McGauran G; Dedalus HealthCare GmbH, Bonn, Germany.
  • O'Connor G; Health Products Regulatory Authority, Dublin, Ireland.
  • Vasey B; Health Products Regulatory Authority, Dublin, Ireland.
  • Rademakers FE; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Expert Rev Med Devices ; 20(6): 467-491, 2023 Jun.
Article en En | MEDLINE | ID: mdl-37157833
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Programas Informáticos / Inteligencia Artificial Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Expert Rev Med Devices Asunto de la revista: DIAGNOSTICO POR IMAGEM / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Programas Informáticos / Inteligencia Artificial Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Expert Rev Med Devices Asunto de la revista: DIAGNOSTICO POR IMAGEM / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido