{"id":23677,"date":"2022-05-03T13:22:23","date_gmt":"2022-05-03T12:22:23","guid":{"rendered":"https:\/\/ppr-antibioresistance.inserm.fr\/?p=23677"},"modified":"2022-05-03T13:22:26","modified_gmt":"2022-05-03T12:22:26","slug":"astar-de-q-lineaclasse-comme-dispositif-revolutionnaire-par-la-fda","status":"publish","type":"post","link":"https:\/\/ppr-antibioresistance.inserm.fr\/en\/informations-et-communications\/actualites\/astar-de-q-lineaclasse-comme-dispositif-revolutionnaire-par-la-fda\/","title":{"rendered":"ASTar de Q-linea\u2019class\u00e9 comme dispositif r\u00e9volutionnaire par la FDA"},"content":{"rendered":"\n<p>Article publi\u00e9 sur <a href=\"https:\/\/www.zonebourse.com\/cours\/action\/Q-LINEA-AB-PUBL-47515620\/actualite\/ASTar-de-Q-linea-146-classe-comme-dispositif-revolutionnaire-par-la-FDA-40032455\/\" target=\"_blank\" rel=\"noreferrer noopener\">zonebourse.com<\/a> le 08 avril 2022<\/p>\n\n\n\n<p>Q-linea AB (publ) a annonc\u00e9 que ASTar a re\u00e7u la d\u00e9signation de dispositif r\u00e9volutionnaire par la Food and Drug Administration (FDA) des \u00c9tats-Unis. La cat\u00e9gorisation &#8220;dispositif r\u00e9volutionnaire&#8221; peut \u00eatre attribu\u00e9e aux produits qui sont consid\u00e9r\u00e9s comme fournissant un traitement plus efficace d&#8217;\u00e9tats pathologiques graves, o\u00f9 il n&#8217;existe aucun \u00e9quivalent comparable sur le march\u00e9. Cette cat\u00e9gorisation vise \u00e0 acc\u00e9l\u00e9rer l&#8217;examen r\u00e9glementaire des dispositifs m\u00e9dicaux afin que les patients b\u00e9n\u00e9ficient d&#8217;un acc\u00e8s plus rapide aux nouvelles options de traitement. <\/p>\n\n\n\n<p>C&#8217;est un v\u00e9ritable t\u00e9moignage du travail de Q-linea qui d\u00e9veloppe une technologie r\u00e9volutionnaire dans le but d&#8217;aider \u00e0 sauver des vies. Le fait d&#8217;\u00eatre class\u00e9 comme un dispositif r\u00e9volutionnaire par la FDA est une v\u00e9ritable \u00e9tape en soi, mais nous voyons \u00e9galement les possibilit\u00e9s de mettre ASTar sur le march\u00e9 am\u00e9ricain plus rapidement gr\u00e2ce \u00e0 un examen r\u00e9glementaire prioritaire. <\/p>\n\n\n\n<p>ASTar Instrument et ASTar BC G-Kit apportent d\u00e9j\u00e0 la r\u00e9ponse la plus large concernant la combinaison du nombre d&#8217;antibiotiques et du nombre d&#8217;\u00e9tapes de double dilution de chaque antibiotique, en une seule analyse pour les bact\u00e9ries gram-n\u00e9gatives. <\/p>\n\n\n\n<p>Le test permet l&#8217;analyse des bact\u00e9ries gram-n\u00e9gatives, y compris les bact\u00e9ries difficiles \u00e0 cultiver dites fastidieuses, ce qui r\u00e9pond au besoin de r\u00e9sultats rapides et complets pour soutenir des d\u00e9cisions de traitement optimales. <\/p>\n\n\n\n<p>L&#8217;instrument ASTar et le kit ASTar BC G- sont marqu\u00e9s CE mais ne sont pas autoris\u00e9s par la FDA 510(k) et ne sont pas disponibles \u00e0 la vente aux \u00c9tats-Unis.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Article publi\u00e9 sur zonebourse.com le 08 avril 2022 Q-linea AB (publ) a annonc\u00e9 que ASTar a re\u00e7u la d\u00e9signation de dispositif r\u00e9volutionnaire par la Food and Drug Administration (FDA) des \u00c9tats-Unis. La cat\u00e9gorisation &#8220;dispositif r\u00e9volutionnaire&#8221; peut \u00eatre attribu\u00e9e aux produits qui sont consid\u00e9r\u00e9s comme fournissant un traitement plus efficace d&#8217;\u00e9tats pathologiques graves, o\u00f9 il n&#8217;existe [&hellip;]<\/p>\n","protected":false},"author":139,"featured_media":23685,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[31],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ASTar de Q-linea\u2019class\u00e9 comme dispositif r\u00e9volutionnaire par la FDA - French\u00a0National ANTIBIOTIC RESISTANCE Portal<\/title>\n<meta name=\"description\" content=\"Informations, \u00e9v\u00e8nements et actualit\u00e9s autour de l&#039;Antibior\u00e9sistance en France et \u00e0 l&#039;international.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ppr-antibioresistance.inserm.fr\/en\/informations-et-communications\/actualites\/astar-de-q-lineaclasse-comme-dispositif-revolutionnaire-par-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ASTar de Q-linea\u2019class\u00e9 comme dispositif r\u00e9volutionnaire par la FDA - 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