{"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\/es\/vigilant-biosciences-recibe-la-designacion-de-dispositivo-innovador-de-la-fda\/","title":{"rendered":"Vigilant Biosciences\u00ae recibe la designaci\u00f3n de dispositivo innovador de la FDA para una prueba en el lugar de atenci\u00f3n para ayudar en la detecci\u00f3n temprana del c\u00e1ncer oral"},"content":{"rendered":"<p>LAKEWAY, Texas (27 de abril de 2023) \u2014 Vigilant Biosciences\u00ae, Inc. (\u201cVigilant\u201d), un innovador y desarrollador l\u00edder de soluciones que ayudan en la detecci\u00f3n temprana del c\u00e1ncer oral, se enorgullece de anunciar la recepci\u00f3n de la designaci\u00f3n de dispositivo innovador de la industria de alimentos. y Administraci\u00f3n de Medicamentos (FDA) por su prueba en el lugar de atenci\u00f3n para ayudar en la detecci\u00f3n temprana del c\u00e1ncer oral.<\/p>\n<p>La prueba BeVigilant\u2122 OraFusion\u2122 es la primera de su tipo que proporciona una herramienta para la detecci\u00f3n del c\u00e1ncer oral mediante la determinaci\u00f3n de la presencia de ciertos biomarcadores combinados con software de inteligencia artificial para factores de riesgo cl\u00ednicos. La detecci\u00f3n temprana, definida por la detecci\u00f3n en la Etapa 1 o la Etapa 2, puede conducir a resultados significativamente mejores con tasas de supervivencia tan altas como 90%. La tasa actual de supervivencia del c\u00e1ncer oral es de solo 50% debido al retraso en la intervenci\u00f3n.<\/p>\n<p>&quot;Esta designaci\u00f3n innovadora es un hito fundamental en el proceso de revisi\u00f3n de lo que creemos que es una tecnolog\u00eda que salva vidas&quot;, dijo Bill Brodie, director ejecutivo de Vigilant Biosciences\u00ae. &quot;Los resultados cl\u00ednicos en curso indican importantes beneficios ofrecidos a los pacientes y nos permiten continuar con nuestra misi\u00f3n de proporcionar una soluci\u00f3n de detecci\u00f3n temprana de clase mundial para la presencia de c\u00e1ncer oral&quot;.<\/p>\n<p>El Programa de Dispositivos Avanzados se cre\u00f3 para brindar a los pacientes un acceso m\u00e1s oportuno a dispositivos m\u00e9dicos innovadores al acelerar su desarrollo, evaluaci\u00f3n y revisi\u00f3n, preservando al mismo tiempo los est\u00e1ndares legales para la aprobaci\u00f3n previa a la comercializaci\u00f3n, la autorizaci\u00f3n 510(k) y la autorizaci\u00f3n de comercializaci\u00f3n de DeNovo, seg\u00fan la FDA. .<\/p>\n<h3>Acerca de Vigilant Biosciences\u00ae, Inc.<\/h3>\n<p>Vigilant Biosciences\u00ae es un innovador l\u00edder y desarrollador de soluciones que ayudan a los m\u00e9dicos en la detecci\u00f3n temprana del c\u00e1ncer oral. La l\u00ednea de productos BeVigilant\u2122 de Vigilant incluye pruebas en el lugar de atenci\u00f3n que son simples, precisas y rentables, y permite a los profesionales de la salud mejorar vidas mediante una intervenci\u00f3n m\u00e1s temprana. El sistema BeVigilant\u2122 OraFusion\u2122 no est\u00e1 disponible para la venta en EE. UU.<\/p>","protected":false},"excerpt":{"rendered":"<p>Vigilant Biosciences\u00ae recibe la designaci\u00f3n de dispositivo innovador de la FDA para una prueba en el lugar de atenci\u00f3n para la detecci\u00f3n temprana del c\u00e1ncer 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 - 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\/es\/vigilant-biosciences-recibe-la-designacion-de-dispositivo-innovador-de-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\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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