Un Chemin Réglementaire Européen Pour Le Tidepool Loop Suite À L'homologation Aux États-Unis?
PMID : 37873612 ·
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Résumé
The recent clearance by the United States Food and Drug Administration of Tidepool Loop sets an important precedent within the medical device landscape. For the first time, an automated insulin delivery mobile application-based on an algorithm initially designed and developed by users -has been recognised as safe and effective by a regulatory body. The aim of this paper is twofold: firstly, we map out the regulatory pathways and processes that were navigated by Tidepool, the non-profit behind Ti
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Source officielle
Voir sur PubMed →Données issues de PubMed / NCBI. Pour le texte intégral et les informations les plus récentes, consultez toujours la notice officielle.