{"id":1,"date":"2023-04-27T08:00:07","date_gmt":"2023-04-27T08:00:07","guid":{"rendered":"https:\/\/vigilantbio.wpengine.com\/?p=1"},"modified":"2023-07-18T16:31:04","modified_gmt":"2023-07-18T16:31:04","slug":"vigilant-biosciences-receives-breakthrough-device-designation-from-fda","status":"publish","type":"post","link":"https:\/\/vigilantbiosciences.com\/fr\/les-biosciences-vigilantes-recoivent-la-designation-de-dispositif-revolutionnaire-de-la-fda\/","title":{"rendered":"Vigilant Biosciences\u00ae re\u00e7oit la d\u00e9signation de dispositif r\u00e9volutionnaire de la FDA pour un test sur le lieu d&#039;intervention visant \u00e0 faciliter la d\u00e9tection pr\u00e9coce du cancer de la bouche"},"content":{"rendered":"<p>LAKEWAY, Texas (27 avril 2023) \u2014 Vigilant Biosciences\u00ae, Inc. (\u00ab Vigilant \u00bb), l&#039;un des principaux innovateurs et d\u00e9veloppeurs de solutions facilitant la d\u00e9tection pr\u00e9coce du cancer de la bouche, est fier d&#039;annoncer la r\u00e9ception de la d\u00e9signation de dispositif r\u00e9volutionnaire de l&#039;industrie alimentaire. et Drug Administration (FDA) pour son test au point d&#039;intervention destin\u00e9 \u00e0 faciliter la d\u00e9tection pr\u00e9coce du cancer de la bouche.<\/p>\n<p>Le test BeVigilant\u2122 OraFusion\u2122 est le premier du genre \u00e0 fournir un outil de d\u00e9tection du cancer de la bouche en d\u00e9terminant la pr\u00e9sence de certains biomarqueurs combin\u00e9 \u00e0 un logiciel d&#039;intelligence artificielle pour les facteurs de risque cliniques. La d\u00e9tection pr\u00e9coce, telle que d\u00e9finie par la d\u00e9tection au stade 1 ou au stade 2, peut conduire \u00e0 des r\u00e9sultats consid\u00e9rablement am\u00e9lior\u00e9s avec des taux de survie aussi \u00e9lev\u00e9s que 90%. Le taux actuel de survie au cancer de la bouche n\u2019est que de 50% en raison d\u2019une intervention retard\u00e9e.<\/p>\n<p>\u00ab Cette d\u00e9signation r\u00e9volutionnaire constitue une \u00e9tape cruciale dans le processus d&#039;examen de ce que nous consid\u00e9rons comme une technologie qui sauve des vies \u00bb, a d\u00e9clar\u00e9 Bill Brodie, PDG de Vigilant Biosciences\u00ae. \u00ab Les r\u00e9sultats cliniques en cours indiquent des avantages significatifs offerts aux patients et nous permettent de poursuivre notre mission consistant \u00e0 fournir une solution de d\u00e9tection pr\u00e9coce de classe mondiale pour la pr\u00e9sence du cancer de la bouche. \u00bb<\/p>\n<p>Le programme Breakthrough Devices a \u00e9t\u00e9 cr\u00e9\u00e9 pour fournir aux patients un acc\u00e8s plus rapide \u00e0 des dispositifs m\u00e9dicaux innovants en acc\u00e9l\u00e9rant leur d\u00e9veloppement, leur \u00e9valuation et leur examen tout en pr\u00e9servant les normes statutaires en mati\u00e8re d&#039;approbation pr\u00e9alable \u00e0 la commercialisation, d&#039;autorisation 510(k) et d&#039;autorisation de mise sur le march\u00e9 DeNovo, selon la FDA. .<\/p>\n<h3>\u00c0 propos de Vigilant Biosciences\u00ae, Inc.<\/h3>\n<p>Vigilant Biosciences\u00ae est un innovateur et d\u00e9veloppeur de premier plan de solutions qui aident les cliniciens \u00e0 d\u00e9tecter pr\u00e9cocement le cancer de la bouche. La gamme de produits BeVigilant\u2122 de Vigilant comprend des tests au point d&#039;intervention qui sont simples, pr\u00e9cis et rentables, et permet aux professionnels de la sant\u00e9 d&#039;am\u00e9liorer la vie gr\u00e2ce \u00e0 une intervention plus pr\u00e9coce. Le syst\u00e8me BeVigilant\u2122 OraFusion\u2122 n&#039;est pas disponible \u00e0 la vente aux \u00c9tats-Unis<\/p>","protected":false},"excerpt":{"rendered":"<p>Vigilant Biosciences\u00ae re\u00e7oit la d\u00e9signation de dispositif r\u00e9volutionnaire de la FDA pour un test sur le lieu d&#039;intervention destin\u00e9 \u00e0 la d\u00e9tection pr\u00e9coce du cancer de la bouche<\/p>","protected":false},"author":1,"featured_media":383,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"off","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-release"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Vigilant Biosciences\u00ae Receives Breakthrough Device Designation from FDA for Point-of-Care Test to Aid in the Early Detection of Oral Cancer - 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