{"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\/tr\/uyanik-biyobilimler-fdadan-cigir-acan-cihaz-unvanini-aldi\/","title":{"rendered":"Vigilant Biosciences\u00ae, A\u011f\u0131z Kanserinin Erken Te\u015fhisine Yard\u0131mc\u0131 Olmak \u00dczere Bak\u0131m Noktas\u0131 Testi i\u00e7in FDA'dan \u00c7\u0131\u011f\u0131r A\u00e7an Cihaz Unvan\u0131n\u0131 Ald\u0131"},"content":{"rendered":"

LAKEWAY, Texas (27 Nisan 2023) \u2014 Vigilant Biosciences\u00ae, Inc. A\u011f\u0131z kanserinin erken tespitine yard\u0131mc\u0131 olan \u00f6nde gelen bir yenilik\u00e7i ve \u00e7\u00f6z\u00fcm geli\u015ftiricisi olan (\u201cVigilant\u201d), a\u011f\u0131z kanserinin erken tan\u0131lamas\u0131na ve tespitine yard\u0131mc\u0131 olmak \u00fczere bak\u0131m noktas\u0131 testi i\u00e7in G\u0131da ve \u0130la\u00e7 Dairesinden (FDA) \u00c7\u0131\u011f\u0131r A\u00e7an Cihaz Tan\u0131mlamas\u0131n\u0131n al\u0131nd\u0131\u011f\u0131n\u0131 duyurmaktan gurur duymaktad\u0131r.<\/p>\n

BeVigilant\u2122 OraFusion\u2122 Testi, klinik risk fakt\u00f6rleri i\u00e7in yapay zeka yaz\u0131l\u0131m\u0131 ile birlikte belirli biyobelirte\u00e7lerin varl\u0131\u011f\u0131n\u0131 belirleyerek oral kanser tespiti i\u00e7in bir ara\u00e7 sa\u011flayan t\u00fcr\u00fcn\u00fcn ilk \u00f6rne\u011fidir. Evre 1 veya Evre 2'de tespit ile tan\u0131mlanan erken tespit, 'a varan sa\u011fkal\u0131m oranlar\u0131 ile \u00f6nemli \u00f6l\u00e7\u00fcde iyile\u015ftirilmi\u015f sonu\u00e7lara yol a\u00e7abilir. Mevcut oral kanser sa\u011fkal\u0131m oran\u0131, gecikmi\u015f giri\u015fim nedeniyle yaln\u0131zca 'dir.<\/p>\n

Vigilant Biosciences\u00ae CEO'su Bill Brodie, \u201cBu \u00c7\u0131\u011f\u0131r A\u00e7an Tan\u0131mlama, hayat kurtaran bir teknoloji oldu\u011funa inand\u0131\u011f\u0131m\u0131z \u015feyin g\u00f6zden ge\u00e7irme s\u00fcrecinde kritik bir d\u00f6n\u00fcm noktas\u0131d\u0131r\u201d dedi. \u201cDevam eden klinik sonu\u00e7lar, hastalara sunulan \u00f6nemli faydalara i\u015faret ediyor ve a\u011f\u0131z kanseri varl\u0131\u011f\u0131 i\u00e7in birinci s\u0131n\u0131f bir erken tespit \u00e7\u00f6z\u00fcm\u00fc sa\u011flama misyonumuzu s\u00fcrd\u00fcrmemize olanak tan\u0131yor.\u201d<\/p>\n

\u00c7\u0131\u011f\u0131r A\u00e7an Cihazlar Program\u0131, FDA'ya g\u00f6re pazarlama \u00f6ncesi onay, 510(k) izin ve DeNovo pazarlama izni i\u00e7in yasal standartlar\u0131 korurken, geli\u015ftirme, de\u011ferlendirme ve incelemelerini h\u0131zland\u0131rarak hastalara yenilik\u00e7i t\u0131bbi cihazlara daha zaman\u0131nda eri\u015fim sa\u011flamak i\u00e7in olu\u015fturulmu\u015ftur.<\/p>\n

Vigilant Biosciences\u00ae, Inc. Hakk\u0131nda<\/h3>\n

Vigilant Biosciences\u00ae, klinisyenlere a\u011f\u0131z kanserinin erken tespitinde yard\u0131mc\u0131 olan \u00f6nde gelen bir yenilik\u00e7i ve geli\u015ftiricidir. Vigilant\u2019\u0131n BeVigilant\u2122 \u00fcr\u00fcn serisi, basit, do\u011fru ve uygun maliyetli bak\u0131m noktas\u0131 testlerini i\u00e7erir ve sa\u011fl\u0131k \u00e7al\u0131\u015fanlar\u0131n\u0131n daha erken giri\u015fimlerle ya\u015famlar\u0131n\u0131 iyile\u015ftirmelerini sa\u011flar. BeVigilant\u2122 OraFusion\u2122 Sistemi ABD'de sat\u0131lmamaktad\u0131r.<\/p>","protected":false},"excerpt":{"rendered":"

Vigilant Biosciences\u00ae, A\u011f\u0131z Kanserinin Erken Te\u015fhisine Y\u00f6nelik Bak\u0131m Noktas\u0131 Testi i\u00e7in FDA'dan \u00c7\u0131\u011f\u0131r A\u00e7an Cihaz Unvan\u0131n\u0131 Ald\u0131<\/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\/tr\/uyanik-biyobilimler-fdadan-cigir-acan-cihaz-unvanini-aldi\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\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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