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Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine.

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第一作者: Hikmet Can,Çubukçu
第一单位: Rare Diseases Department, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Türkiye.;Department of Medical Biochemistry, Sincan Training and Research Hospital, Ankara, Türkiye.
作者单位: Rare Diseases Department, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Türkiye.;Department of Medical Biochemistry, Sincan Training and Research Hospital, Ankara, Türkiye. [1] CHU Montpellier, Department of Molecular Genetics and Cytogenomics, National Reference Laboratory of Autoinflammatory Diseases, French National Reference Center of Autoinflammatory Diseases and Amyloidosis (CeRéMAIA), IRMB, INSERM U1183, Univ Montpellier, Montpellier, France. [2] Linko Q-Solutions, Helsinki, Finland. [3] Servicio Bioquímica - Análisis Clínicos Hospital Universitario Puerta de Hierro, Madrid, Spain. [4] Department of Clinical Chemistry, University Clinic for Respiratory and Allergic Diseases, Golnik, Slovenia. [5] Department of Medical and Experimental Biochemistry, Faculty of Medicine, University Ss."Kiril and Metodij", Skopje, North Macedonia. [6] Central Laboratory for Clinical Chemistry, Spedali Civili, Brescia, Italy. [7] Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia. [8] Department of Medicine (DIMED), University of Padova and University Hospital of Padova, Padova, Italy. [9] SKML, Nijmegen, The Netherlands.;Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. [10]
DOI 10.1515/cclm-2025-0482
PMID 40440607
发布时间 2025-09-03
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Clinical chemistry and laboratory medicine

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