{"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\/nl\/waakzame-biowetenschappen-ontvangt-baanbrekende-apparaataanduiding-van-fda\/","title":{"rendered":"Vigilant Biosciences\u00ae ontvangt baanbrekende apparaataanduiding van FDA voor Point-of-Care-test ter ondersteuning van de vroege detectie van mondkanker"},"content":{"rendered":"

LAKEWAY, Texas (27 april 2023) \u2013 Vigilant Biosciences\u00ae, Inc. (\u201cVigilant\u201d), een toonaangevende innovator en ontwikkelaar van oplossingen die helpen bij de vroege detectie van mondkanker, kondigt met trots de ontvangst aan van de Breakthrough Device Designation van de Food and Drug Administration (FDA) voor zijn point-of-care-test om te helpen bij de vroege detectie van mondkanker.<\/p>\n

De BeVigilant\u2122 OraFusion\u2122 Test is de eerste in zijn soort die een hulpmiddel biedt voor de detectie van mondkanker door de aanwezigheid van bepaalde biomarkers te bepalen in combinatie met kunstmatige intelligentiesoftware voor klinische risicofactoren. Vroege detectie, zoals gedefinieerd door detectie in fase 1 of fase 2, kan leiden tot aanzienlijk betere resultaten met overlevingspercentages zo hoog als 90%. Het huidige overlevingspercentage voor mondkanker bedraagt slechts 50% als gevolg van vertraagde interventie.<\/p>\n

\u201cDeze Doorbraak-aanduiding is een cruciale mijlpaal in het beoordelingsproces van wat volgens ons een levensreddende technologie is\u201d, aldus Bill Brodie, CEO van Vigilant Biosciences\u00ae. \u201cVoortdurende klinische resultaten wijzen op aanzienlijke voordelen voor pati\u00ebnten en stellen ons in staat onze missie voort te zetten: het bieden van een oplossing voor vroege detectie van wereldklasse voor de aanwezigheid van mondkanker.\u201d<\/p>\n

Het Breakthrough Devices Program is in het leven geroepen om pati\u00ebnten tijdiger toegang te bieden tot innovatieve medische hulpmiddelen door de ontwikkeling, beoordeling en beoordeling ervan te versnellen, terwijl de wettelijke normen voor goedkeuring v\u00f3\u00f3r het op de markt brengen, 510(k)-goedkeuring en vergunning voor het in de handel brengen van DeNovo behouden blijven, aldus de FDA. .<\/p>\n

Over Vigilant Biosciences\u00ae, Inc.<\/h3>\n

Vigilant Biosciences\u00ae is een toonaangevende innovator en ontwikkelaar van oplossingen die artsen helpen bij de vroege detectie van mondkanker. De BeVigilant\u2122-productlijn van Vigilant omvat point-of-care-testen die eenvoudig, nauwkeurig en kosteneffectief zijn, en stelt zorgverleners in staat levens te verbeteren door eerdere interventies. Het BeVigilant\u2122 OraFusion\u2122-systeem is niet verkrijgbaar in de VS<\/p>","protected":false},"excerpt":{"rendered":"

Vigilant Biosciences\u00ae ontvangt baanbrekende apparaataanduiding van FDA voor Point-of-Care-test voor vroege detectie van mondkanker<\/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":"\nVigilant Biosciences\u00ae Receives Breakthrough Device Designation from FDA for Point-of-Care Test to Aid in the Early Detection of Oral Cancer - Vigilant Biosciences\u00ae<\/title>\n<meta name=\"description\" content=\"We are happy to receive Breakthrough Device Designation from the FDA for our point-of-care test to aid in the early detection of oral cancer.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/vigilantbiosciences.com\/nl\/waakzame-biowetenschappen-ontvangt-baanbrekende-apparaataanduiding-van-fda\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"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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