{"id":15913,"date":"2026-02-10T17:45:00","date_gmt":"2026-02-10T16:45:00","guid":{"rendered":"https:\/\/www.maunakeatech.com\/?p=15913"},"modified":"2026-02-10T19:57:27","modified_gmt":"2026-02-10T18:57:27","slug":"mauna-kea-technologies-annonce-lobtention-du-marquage-ce-mdr-pour-le-cellvizio-et-ses-sondes-associees","status":"publish","type":"post","link":"https:\/\/www.maunakeatech.com\/fr\/actualites\/mauna-kea-technologies-annonce-lobtention-du-marquage-ce-mdr-pour-le-cellvizio-et-ses-sondes-associees\/","title":{"rendered":"Mauna Kea Technologies annonce l\u2019obtention du marquage CE MDR pour le Cellvizio\u00ae et ses sondes associ\u00e9es"},"content":{"rendered":"\n

Franchissement d\u2019une \u00e9tape r\u00e9glementaire majeure dans la strat\u00e9gie d\u2019expansion commerciale en Europe

Mauna Kea Technologies est la seule soci\u00e9t\u00e9 d’endomicroscopie \u00e0 b\u00e9n\u00e9ficier de cette certification sous le nouveau r\u00e8glement europ\u00e9en
<\/strong><\/em><\/p>\n\n\n\n

Paris, le 10 f\u00e9vrier 2026 – 17h45 CET \u2013 Mauna Kea Technologies (Euronext Growth: ALMKT) <\/strong>inventeur de Cellvizio\u00ae, la plateforme multidisciplinaire d’endomicroscopie confocale laser par minisonde et par aiguille (p\/nCLE), annonce aujourd\u2019hui avoir re\u00e7u la certification de conformit\u00e9 au R\u00e8glement Europ\u00e9en sur les Dispositifs M\u00e9dicaux (MDR 2017\/745) pour l\u2019ensemble de son syst\u00e8me Cellvizio et sa gamme de sondes.<\/p>\n\n\n\n

Cette certification a \u00e9t\u00e9 d\u00e9livr\u00e9e par le GMED, organisme notifi\u00e9 de r\u00e9f\u00e9rence et l’un des plus exigeants du secteur. Elle confirme que la plateforme Cellvizio r\u00e9pond aux crit\u00e8res de s\u00e9curit\u00e9 et de performance clinique les plus stricts \u00e0 l’\u00e9chelle internationale. Ce marquage permet de s\u00e9curiser durablement la commercialisation du Cellvizio au sein de l\u2019Union Europ\u00e9enne et des pays qui reconnaissent le marquage CE Il ouvre la voie au d\u00e9ploiement de nouvelles applications cliniques ainsi qu’\u00e0 l’int\u00e9gration future de solutions d’Intelligence Artificielle dans le cadre r\u00e9glementaire actuel. <\/p>\n\n\n\n

Sacha Loiseau, Ph.D., Pr\u00e9sident-Directeur G\u00e9n\u00e9ral de Mauna Kea Technologies<\/strong>, a comment\u00e9 : \u00ab Le passage au MDR repr\u00e9sente l\u2019un des d\u00e9fis les plus s\u00e9v\u00e8res que le secteur MedTech ait connu en Europe. L\u2019obtention de cette certification prouve encore une fois l\u2019excellence de nos processus qualit\u00e9 et la sup\u00e9riorit\u00e9 clinique de Cellvizio. C\u2019est un catalyseur puissant dans notre strat\u00e9gie d\u2019expansion commerciale en Europe sur nos deux axes cliniques \u00e0 fort potentiel, les kystes pancr\u00e9atiques et les intol\u00e9rances alimentaires (CellTolerance). \u00bb <\/em><\/p>\n\n\n\n

 <\/p>\n\n\n\n

VOIR LE COMMUNIQU\u00c9 DE PRESSE<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Franchissement d\u2019une \u00e9tape r\u00e9glementaire majeure dans la strat\u00e9gie d\u2019expansion commerciale en Europe Mauna Kea Technologies est la seule soci\u00e9t\u00e9 d’endomicroscopie \u00e0 b\u00e9n\u00e9ficier de cette certification sous le nouveau r\u00e8glement europ\u00e9en Paris, le 10 f\u00e9vrier 2026 – 17h45 CET \u2013 Mauna Kea Technologies (Euronext Growth: ALMKT) inventeur de Cellvizio\u00ae, la plateforme multidisciplinaire d’endomicroscopie confocale laser par […]<\/p>\n","protected":false},"author":4,"featured_media":3910,"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":"","footnotes":""},"categories":[29],"tags":[],"class_list":["post-15913","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"yoast_head":"\nMauna Kea Technologies annonce l\u2019obtention du marquage CE MDR pour le Cellvizio\u00ae et ses sondes associ\u00e9es - 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