{"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\/it\/vigilant-biosciences-riceve-la-designazione-del-dispositivo-rivoluzionario-dalla-fda\/","title":{"rendered":"Vigilant Biosciences\u00ae riceve la designazione di dispositivo innovativo dalla FDA per il test point-of-care in grado di aiutare a individuare precocemente il tumore orale"},"content":{"rendered":"

LAKEWAY, Texas (27 aprile 2023) \u2014 Vigilant Biosciences\u00ae, Inc. (\u201cVigilant\u201d), innovatore leader e sviluppatore di soluzioni che aiutano nella diagnosi precoce del tumore orale, \u00e8 orgoglioso di annunciare la ricezione della designazione di dispositivo innovativo da parte dell\u2019Ente statunitense preposto alla tutela di alimenti e medicinali (Food and Drug Administration, FDA) per il suo test point-of-care che facilita la diagnosi precoce del tumore orale.<\/p>\n

Il test BeVigilant\u2122 OraFusion\u2122 \u00e8 il primo del suo genere a fornire uno strumento per il rilevamento del tumore orale, determinando la presenza di alcuni biomarcatori combinati con il software di intelligenza artificiale per i fattori di rischio clinico. Il rilevamento precoce, definito dalla rilevazione allo Stadio 1 o allo Stadio 2, pu\u00f2 portare a esiti significativamente migliori con tassi di sopravvivenza fino al 90%. L\u2019attuale tasso di sopravvivenza del tumore orale \u00e8 solo del 50% a causa di un intervento ritardato.<\/p>\n

\u201cQuesta designazione di dispositivo innovativo \u00e8 una pietra miliare fondamentale nel processo di revisione di ci\u00f2 che riteniamo essere una tecnologia salvavita\u201d, ha affermato Bill Brodie, Amministratore Delegato di Vigilant Biosciences\u00ae. \u201cI risultati clinici in corso indicano benefici significativi offerti ai pazienti e ci consentono di continuare la nostra missione, che consiste nel fornire una soluzione di livello mondiale per il rilevamento precoce della presenza di tumore orale\u201d.<\/p>\n

Il Programma sui dispositivi innovativi \u00e8 stato creato per fornire ai pazienti un accesso pi\u00f9 tempestivo ai dispositivi medici innovativi, accelerandone lo sviluppo, la valutazione e la revisione, ma preservando al contempo gli standard legali per l\u2019approvazione pre-commercializzazione, l\u2019autorizzazione 510(k) e l\u2019autorizzazione all\u2019immissione in commercio DeNovo, secondo l\u2019FDA.<\/p>\n

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

Vigilant Biosciences\u00ae \u00e8 un innovatore leader e sviluppatore di soluzioni che aiutano i medici nella diagnosi precoce del tumore orale. La linea di prodotti BeVigilant\u2122 di Vigilant include test point-of-care che sono semplici, accurati ed economicamente vantaggiosi e consente agli operatori sanitari di migliorare la vita dei loro pazienti attraverso un intervento precoce. Il sistema BeVigilant\u2122 OraFusion\u2122 non \u00e8 disponibile per la vendita negli Stati Uniti.<\/p>","protected":false},"excerpt":{"rendered":"

Vigilant Biosciences\u00ae riceve la designazione di dispositivo rivoluzionario dalla FDA per il test point-of-care per la diagnosi precoce del cancro orale<\/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\/it\/vigilant-biosciences-riceve-la-designazione-del-dispositivo-rivoluzionario-dalla-fda\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\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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