{"id":2905,"date":"2022-06-02T20:05:12","date_gmt":"2022-06-02T20:05:12","guid":{"rendered":"https:\/\/www.africa-press.net\/sao-tome-e-principe\/politique\/smaio-obtient-lenregistrement-510k-de-la-fda-pour-son-logiciel-de-planification-chirurgicale-balance-analyzer-3d"},"modified":"2022-06-02T20:20:01","modified_gmt":"2022-06-02T20:20:01","slug":"smaio-obtient-lenregistrement-510k-de-la-fda-pour-son-logiciel-de-planification-chirurgicale-balance-analyzer-3d","status":"publish","type":"post","link":"https:\/\/www.africa-press.net\/sao-tome-e-principe\/toutes-les-actualites\/smaio-obtient-lenregistrement-510k-de-la-fda-pour-son-logiciel-de-planification-chirurgicale-balance-analyzer-3d","title":{"rendered":"SMAIO obtient l&rsquo;enregistrement 510(k) de la FDA pour son logiciel de planification chirurgicale Balance Analyzer 3D"},"content":{"rendered":"<p><span style=\"color: #ff6600\"><strong>Africa-Press &#8211; S\u00e3o Tom\u00e9 e Pr\u00edncipe. <\/strong><\/span>SMAIO, un acteur fran\u00e7ais sp\u00e9cialis\u00e9 dans la chirurgie rachidienne complexe disposant d&rsquo;une offre globale compos\u00e9e de logiciels, de dispositifs implantables et de services associ\u00e9s, annonce aujourd&rsquo;hui l&rsquo;obtention de l&rsquo;enregistrement 510(k) de la Food and Drug Administration (FDA) pour son logiciel de planification chirurgicale Balance Analyzer 3D.<\/p>\n<p>Balance Analyzer 3D est un logiciel de planification du r\u00e9alignement vert\u00e9bral \u00e0 partir de l&rsquo;imagerie m\u00e9dicale de la colonne vert\u00e9brale du patient. Depuis son marquage CE en 2014, il fait partie int\u00e9grante de la solution de planification chirurgicale i-plan commercialis\u00e9e par SMAIO au sein de sa plateforme compl\u00e8te, i-kontrol, qui permet aux chirurgiens de traiter de fa\u00e7on efficace, s\u00fbre et durable les pathologies de la colonne vert\u00e9brale.<\/p>\n<p>Philippe ROUSSOULY, Pr\u00e9sident directeur g\u00e9n\u00e9ral de SMAIO, conclut : \u00ab\u00a0L&rsquo;enregistrement 510(k) de la version actuelle de notre logiciel de planification Balance Analyzer 3D marque une \u00e9tape importante de notre strat\u00e9gie de p\u00e9n\u00e9tration du march\u00e9 am\u00e9ricain qui s&rsquo;appuiera, dans les ann\u00e9es \u00e0 venir, sur notre partenariat avec NuVasive. Elle permet de fixer les bases pour les co-d\u00e9veloppements que les deux soci\u00e9t\u00e9s se sont engag\u00e9es \u00e0 mener au cours des deux prochaines ann\u00e9es, et d&rsquo;amorcer \u00e0 tr\u00e8s court terme un certain nombre de collaborations technologiques et scientifiques avec des centres d&rsquo;excellence aux Etats-Unis. Cet enregistrement atteste de la valeur ajout\u00e9e du projet de SMAIO qui vise \u00e0 d\u00e9velopper globalement la solution la plus \u00e0 la pointe pour planifier et ex\u00e9cuter la chirurgie vert\u00e9brale, tenant compte des sp\u00e9cificit\u00e9s de chaque patient.\u00a0\u00bb<\/p>\n<p>L&rsquo;obtention de l&rsquo;homologation 510(k) de la FDA est un \u00e9l\u00e9ment cl\u00e9 d&rsquo;un accord de partenariat et de licence conclu au T1 2022 entre SMAIO et NuVasive, un leader dans les innovations technologiques pour la colonne vert\u00e9brale.<\/p>\n<p><strong>Pour plus d&rsquo;informations et d&rsquo;analyses sur la <a href=\"https:\/\/www.africa-press.net\/sao-tome-e-principe\">S\u00e3o Tom\u00e9 e Pr\u00edncipe<\/a>, suivez <a href=\"https:\/\/www.africa-press.net\/\">Africa-Press<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Africa-Press &#8211; S\u00e3o Tom\u00e9 e Pr\u00edncipe. SMAIO, un acteur fran\u00e7ais sp\u00e9cialis\u00e9 dans la chirurgie rachidienne complexe disposant d&rsquo;une offre globale compos\u00e9e de logiciels, de dispositifs implantables et de services associ\u00e9s, annonce aujourd&rsquo;hui l&rsquo;obtention de l&rsquo;enregistrement 510(k) de la Food and Drug Administration (FDA) pour son logiciel de planification chirurgicale Balance Analyzer 3D. Balance Analyzer 3D [&hellip;]<\/p>\n","protected":false},"author":82,"featured_media":2904,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22,11,10],"tags":[36,55,56],"class_list":["post-2905","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-divers","category-homepage-french","category-toutes-les-actualites","tag-africa-press","tag-africa-press-sao-tome-e-principe","tag-sao-tome-e-principe"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.1 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>SMAIO obtient l&#039;enregistrement 510(k) de la FDA pour son logiciel de planification chirurgicale Balance Analyzer 3D - S\u00e3o Tom\u00e9 e Pr\u00edncipe<\/title>\n<meta name=\"description\" content=\"SMAIO, un acteur fran\u00e7ais sp\u00e9cialis\u00e9 dans la chirurgie rachidienne complexe 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