{"id":4116,"date":"2020-03-03T18:03:00","date_gmt":"2020-03-03T17:03:00","guid":{"rendered":"https:\/\/www.maunakeatech.com\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\/"},"modified":"2024-08-02T12:40:23","modified_gmt":"2024-08-02T10:40:23","slug":"mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation","status":"publish","type":"post","link":"https:\/\/www.maunakeatech.com\/fr\/actualites\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\/","title":{"rendered":"Mauna Kea Technologies re\u00e7oit l\u2019autorisation de la FDA et le marquage CE pour la commercialisation de sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration"},"content":{"rendered":"<h4 style=\"text-align: center;\"><b>La nouvelle plateforme Cellvizio<sup>&reg;<\/sup> pr&eacute;sente des am&eacute;liorations significatives et permettra des innovations majeures&nbsp;<\/b><\/h4>\n<p>Mauna Kea Technologies&nbsp;annonce aujourd&rsquo;hui avoir obtenu un accord 510(k) (<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?ID=K193416\">K193416<\/a>) aux &Eacute;tats-Unis de la Food and Drug Administration (FDA) et le marquage CE de la plateforme d&rsquo;endomicroscopie Cellvizio&reg; de nouvelle g&eacute;n&eacute;ration, d&eacute;velopp&eacute;e avec la nouvelle architecture syst&egrave;me propri&eacute;taire de la soci&eacute;t&eacute;. Il s&rsquo;agit de la 18&egrave;me autorisation 510(k) de la FDA am&eacute;ricaine pour la plateforme Cellvizio<sup>&reg;<\/sup> pCLE\/nCLE.&nbsp;<\/p>\n<p>Cette nouvelle plateforme Cellvizio int&egrave;gre des solutions de conception modulaire innovantes pour faciliter et mieux int&eacute;grer l&rsquo;endomicroscopie dans les salles d&rsquo;op&eacute;ration ainsi que dans des plateformes d&rsquo;autres fabricants. La conception de l&rsquo;&eacute;quipement et du logiciel de la nouvelle plateforme a &eacute;t&eacute; compl&egrave;tement repens&eacute;e afin d&rsquo;accueillir de futurs d&eacute;veloppements, notamment l&rsquo;int&eacute;gration de fonctionnalit&eacute;s d&rsquo;intelligence artificielle (deep learning) pour l&rsquo;interpr&eacute;tation assist&eacute;e des images endomicroscopiques. La nouvelle ergonomie et l&rsquo;encombrement consid&eacute;rablement r&eacute;duit du nouveau Cellvizio permettent une int&eacute;gration facile avec des syst&egrave;mes avanc&eacute;s de navigation, de robotique et de chirurgie laparoscopique. Cette nouvelle plateforme est &eacute;galement capable d&rsquo;int&eacute;grer d&rsquo;autres architectures endomicroscopiques propri&eacute;taires, permettant une imagerie &agrave; d&rsquo;autres longueurs d&rsquo;onde destin&eacute;es &agrave; la chirurgie guid&eacute;e par fluorescence et &agrave; l&rsquo;imagerie mol&eacute;culaire.&nbsp;<\/p>\n<p>Gr&acirc;ce &agrave; une interface utilisateur enti&egrave;rement repens&eacute;e, Cellvizio offre une navigation intelligente pour une plus grande efficacit&eacute; et une meilleure ergonomie. Le tout nouvel &eacute;cran tactile et la connexion de la sonde &agrave; une seule main facilitent l&rsquo;installation et l&rsquo;utilisation. D&eacute;velopp&eacute; pour apporter une imagerie de pr&eacute;cision &agrave; un plus grand nombre de patients avec 9 Minisondes Confocales&trade; d&eacute;di&eacute;es, le nouveau Cellvizio offre des capacit&eacute;s d&rsquo;imagerie de tr&egrave;s haute qualit&eacute;, et apporte aux cliniciens une solution d&rsquo;imagerie tr&egrave;s performante pour les salles d&rsquo;endoscopie, d&rsquo;interventions minimalement invasives et de chirurgie.&nbsp;<\/p>\n<p>&laquo; <i>Nous sommes fiers d&rsquo;annoncer l&rsquo;approbation de la FDA et le marquage CE de notre nouvelle g&eacute;n&eacute;ration de Cellvizio aux &Eacute;tats-Unis et en Europe &raquo;, a d&eacute;clar&eacute; Robert L. Gershon, Directeur G&eacute;n&eacute;ral de Mauna Kea Technologies. &laquo; Le lancement commercial de la plateforme Cellvizio de nouvelle g&eacute;n&eacute;ration aura lieu dans les prochains mois et, gr&acirc;ce &agrave; sa conception modulaire ainsi qu&rsquo;&agrave; sa capacit&eacute; d&rsquo;int&eacute;grer l&rsquo;intelligence artificielle et l&rsquo;imagerie mol&eacute;culaire, elle int&egrave;grera nos futures innovations et indications et permettra de d&eacute;velopper nos partenariats &raquo;.&nbsp;<\/i><\/p>\n<p><\/p>\n<div id=\"old_link\"><a href=\"https:\/\/cdn.maunakeatech.com\/en\/media\/download\/2344\">VOIR LE COMMUNIQU\u00c9 DE PRESSE<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>La nouvelle plateforme Cellvizio&reg; pr&eacute;sente des am&eacute;liorations significatives et permettra des innovations majeures&nbsp; Mauna Kea Technologies&nbsp;annonce aujourd&rsquo;hui avoir obtenu un accord 510(k) (K193416) aux &Eacute;tats-Unis de la Food and Drug Administration (FDA) et le marquage CE de la plateforme d&rsquo;endomicroscopie Cellvizio&reg; de nouvelle g&eacute;n&eacute;ration, d&eacute;velopp&eacute;e avec la nouvelle architecture syst&egrave;me propri&eacute;taire de la soci&eacute;t&eacute;. Il [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4117,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[29],"tags":[],"class_list":["post-4116","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Mauna Kea Technologies re\u00e7oit l\u2019autorisation de la FDA et le marquage CE pour la commercialisation de sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration - Mauna Kea Technologies<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.maunakeatech.com\/fr\/actualites\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mauna Kea Technologies re\u00e7oit l\u2019autorisation de la FDA et le marquage CE pour la commercialisation de sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration - Mauna Kea Technologies\" \/>\n<meta property=\"og:description\" content=\"La nouvelle plateforme Cellvizio&reg; pr&eacute;sente des am&eacute;liorations significatives et permettra des innovations majeures&nbsp; Mauna Kea Technologies&nbsp;annonce aujourd&rsquo;hui avoir obtenu un accord 510(k) (K193416) aux &Eacute;tats-Unis de la Food and Drug Administration (FDA) et le marquage CE de la plateforme d&rsquo;endomicroscopie Cellvizio&reg; de nouvelle g&eacute;n&eacute;ration, d&eacute;velopp&eacute;e avec la nouvelle architecture syst&egrave;me propri&eacute;taire de la soci&eacute;t&eacute;. Il [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.maunakeatech.com\/fr\/actualites\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\/\" \/>\n<meta property=\"og:site_name\" content=\"Mauna Kea Technologies\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/maunakeatech\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-03-03T17:03:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-08-02T10:40:23+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.maunakeatech.com\/wp-content\/uploads\/2024\/08\/4a6cae4837d3d09a6763840beac731711052123e.png\" \/>\n\t<meta property=\"og:image:width\" content=\"330\" \/>\n\t<meta property=\"og:image:height\" content=\"192\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Zina\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@maunakeatech\" \/>\n<meta name=\"twitter:site\" content=\"@maunakeatech\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Zina\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.maunakeatech.com\\\/fr\\\/actualites\\\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.maunakeatech.com\\\/fr\\\/actualites\\\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\\\/\"},\"author\":{\"name\":\"Zina\",\"@id\":\"https:\\\/\\\/www.maunakeatech.com\\\/#\\\/schema\\\/person\\\/f7b9fab57af781ddbbb4933c3f16a4ac\"},\"headline\":\"Mauna Kea Technologies re\u00e7oit l\u2019autorisation de la FDA et le marquage CE pour la commercialisation de sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration\",\"datePublished\":\"2020-03-03T17:03:00+00:00\",\"dateModified\":\"2024-08-02T10:40:23+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.maunakeatech.com\\\/fr\\\/actualites\\\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\\\/\"},\"wordCount\":577,\"image\":{\"@id\":\"https:\\\/\\\/www.maunakeatech.com\\\/fr\\\/actualites\\\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.maunakeatech.com\\\/wp-content\\\/uploads\\\/2024\\\/08\\\/4a6cae4837d3d09a6763840beac731711052123e.png\",\"articleSection\":[\"Actualit\u00e9s\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.maunakeatech.com\\\/fr\\\/actualites\\\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\\\/\",\"url\":\"https:\\\/\\\/www.maunakeatech.com\\\/fr\\\/actualites\\\/mauna-kea-technologies-recoit-lautorisation-de-la-fda-et-le-marquage-ce-pour-la-commercialisation-de-sa-plateforme-cellvizio-de-nouvelle-generation\\\/\",\"name\":\"Mauna Kea Technologies re\u00e7oit l\u2019autorisation de la FDA et le marquage CE pour la commercialisation de sa plateforme Cellvizio\u00ae de nouvelle g\u00e9n\u00e9ration - 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