{"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\/pt\/vigilante-biociencias-recebe-designacao-de-dispositivo-inovador-da-fda\/","title":{"rendered":"Vigilant Biosciences\u00ae recebe designa\u00e7\u00e3o de dispositivo inovador da FDA para testes no local de atendimento para auxiliar na detec\u00e7\u00e3o precoce de c\u00e2ncer oral"},"content":{"rendered":"<p>LAKEWAY, Texas (27 de abril de 2023) \u2014 Vigilant Biosciences\u00ae, Inc. (\u201cVigilant\u201d), uma inovadora e desenvolvedora l\u00edder de solu\u00e7\u00f5es que auxiliam na detec\u00e7\u00e3o precoce do c\u00e2ncer bucal, tem o orgulho de anunciar o recebimento da Designa\u00e7\u00e3o de Dispositivo Inovador da Food e a Drug Administration (FDA) pelo seu teste no local de atendimento para auxiliar na detec\u00e7\u00e3o precoce do c\u00e2ncer bucal.<\/p>\n<p>O teste BeVigilant\u2122 OraFusion\u2122 \u00e9 o primeiro desse tipo a fornecer uma ferramenta para detec\u00e7\u00e3o de c\u00e2ncer bucal, determinando a presen\u00e7a de certos biomarcadores combinados com software de intelig\u00eancia artificial para fatores de risco cl\u00ednicos. A detec\u00e7\u00e3o precoce, conforme definida pela detec\u00e7\u00e3o no Est\u00e1gio 1 ou no Est\u00e1gio 2, pode levar a resultados significativamente melhores, com taxas de sobreviv\u00eancia t\u00e3o altas quanto 90%. A atual taxa de sobreviv\u00eancia ao c\u00e2ncer oral \u00e9 de apenas 50% devido ao atraso na interven\u00e7\u00e3o.<\/p>\n<p>\u201cEsta designa\u00e7\u00e3o inovadora \u00e9 um marco cr\u00edtico no processo de revis\u00e3o do que acreditamos ser uma tecnologia que salva vidas\u201d, disse Bill Brodie, CEO da Vigilant Biosciences\u00ae. \u201cOs resultados cl\u00ednicos cont\u00ednuos indicam benef\u00edcios significativos oferecidos aos pacientes e permitem-nos continuar a nossa miss\u00e3o de fornecer uma solu\u00e7\u00e3o de detec\u00e7\u00e3o precoce de classe mundial para a presen\u00e7a de cancro oral.\u201d<\/p>\n<p>O Programa de Dispositivos Inovadores foi criado para fornecer aos pacientes acesso mais oportuno a dispositivos m\u00e9dicos inovadores, acelerando seu desenvolvimento, avalia\u00e7\u00e3o e revis\u00e3o, preservando os padr\u00f5es legais para aprova\u00e7\u00e3o pr\u00e9-comercializa\u00e7\u00e3o, libera\u00e7\u00e3o 510(k) e autoriza\u00e7\u00e3o de comercializa\u00e7\u00e3o DeNovo, de acordo com o FDA .<\/p>\n<h3>Sobre a Vigilant Biosciences\u00ae, Inc.<\/h3>\n<p>A Vigilant Biosciences\u00ae \u00e9 l\u00edder inovadora e desenvolvedora de solu\u00e7\u00f5es que auxiliam os m\u00e9dicos na detec\u00e7\u00e3o precoce do c\u00e2ncer bucal. A linha de produtos BeVigilant\u2122 da Vigilant inclui testes no local de atendimento que s\u00e3o simples, precisos e econ\u00f4micos, e capacita os profissionais de sa\u00fade a melhorar suas vidas por meio de interven\u00e7\u00e3o precoce. O sistema BeVigilant\u2122 OraFusion\u2122 n\u00e3o est\u00e1 dispon\u00edvel para venda nos EUA<\/p>","protected":false},"excerpt":{"rendered":"<p>Vigilant Biosciences\u00ae recebe designa\u00e7\u00e3o de dispositivo inovador da FDA para teste no local de atendimento para detec\u00e7\u00e3o precoce de c\u00e2ncer oral<\/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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