{"id":11213,"date":"2026-07-07T11:31:38","date_gmt":"2026-07-07T02:31:38","guid":{"rendered":"https:\/\/www.drgemhealthcare.com\/?p=11213"},"modified":"2026-07-07T11:33:55","modified_gmt":"2026-07-07T02:33:55","slug":"drgem-provue-mobile-c-arm-mfds-approval","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/es\/drgem-provue-mobile-c-arm-mfds-approval\/","title":{"rendered":"El C-arm m\u00f3vil de IA PROVUE obtiene la aprobaci\u00f3n de MFDS"},"content":{"rendered":"

Lanzamiento global a gran escala comenzar\u00e1 en la segunda mitad del a\u00f1o<\/strong><\/h3>\n\n\n\n
\n
\"\"<\/figure>\n\n\n\n
    \n
  • Desarrollo de un algoritmo de denoising basado en investigaci\u00f3n conjunta con KAIST, reduciendo la carga de exposici\u00f3n a la radiaci\u00f3n del personal m\u00e9dico y los pacientes<\/li>\n\n\n\n
  • Impulsando un lanzamiento global en la segunda mitad de este a\u00f1o, expandiendo el portafolio de equipos de diagn\u00f3stico por imagen m\u00f3viles<\/li>\n<\/ul>\n\n\n\n

    DRGEM ha obtenido recientemente la certificaci\u00f3n de fabricaci\u00f3n del MFDS para nuestro nuevo arco en C m\u00f3vil PROVUE (sistema de fluoroscopia de rayos X). Esta importante homologaci\u00f3n avala oficialmente nuestra avanzada tecnolog\u00eda de obtenci\u00f3n de im\u00e1genes de baja dosis basada en la inteligencia artificial.<\/p>\n\n\n\n

    Nos complace anunciar que esta certificaci\u00f3n cubre tres modelos: PROVUE-5S, PROVUE-15S y PROVUE-5A. El dispositivo m\u00e9dico cumple plenamente con todos los requisitos regulatorios de seguridad y calidad. Este reconocimiento oficial sienta una base s\u00f3lida para nuestra expansi\u00f3n en los mercados nacional e internacional.<\/p>\n\n\n\n

    Desarrollo de un algoritmo de eliminaci\u00f3n de ruido basado en investigaci\u00f3n conjunta con KAIST<\/h3>\n\n\n\n

    Durante las intervenciones quir\u00fargicas, un sistema de arco en C m\u00f3vil utiliza rayos X en tiempo real. Por lo tanto, el sistema debe minimizar la exposici\u00f3n a la radiaci\u00f3n al tiempo que proporciona im\u00e1genes n\u00edtidas. DRGEM ha incorporado un potente motor de procesamiento de im\u00e1genes basado en inteligencia artificial al arco en C m\u00f3vil PROVUE. Este motor permite obtener im\u00e1genes fluorosc\u00f3picas en tiempo real incluso en entornos de bajo voltaje y baja intensidad de corriente. Esta tecnolog\u00eda reduce la exposici\u00f3n a la radiaci\u00f3n tanto del personal sanitario como de los pacientes. Al mismo tiempo, garantiza una excelente calidad de imagen para un diagn\u00f3stico preciso.<\/p>\n\n\n\n

    Espec\u00edficamente, aplicamos un nuevo algoritmo de eliminaci\u00f3n de ruido desarrollado a trav\u00e9s de una investigaci\u00f3n conjunta con KAIST. Este algoritmo elimina eficazmente el ruido de la imagen durante la obtenci\u00f3n de im\u00e1genes a baja dosis. Reduce la dosis total de radiaci\u00f3n al tiempo que ofrece im\u00e1genes de rayos X n\u00edtidas y claras. Este avance fortalecer\u00e1 nuestro liderazgo tecnol\u00f3gico en el mercado de la fluoroscopia.<\/p>\n\n\n\n

    Dando un salto al Mercado Sanitario Global<\/h3>\n\n\n\n

    La certificaci\u00f3n de fabricaci\u00f3n nacional del arco en C m\u00f3vil PROVUE supone un hito significativo. Este logro demuestra, una vez m\u00e1s, la avanzada tecnolog\u00eda de procesamiento de im\u00e1genes de DRGEM y su gran competitividad en el mercado. Aprovechando este \u00e9xito, estamos acelerando los preparativos para la producci\u00f3n en serie con el fin de presentar oficialmente el sistema al mercado mundial en la segunda mitad de 2026.<\/p>\n\n\n\n

    A trav\u00e9s de una investigaci\u00f3n continua e innovaci\u00f3n de calidad, brindaremos soluciones de im\u00e1genes m\u00e9dicas m\u00e1s seguras y confiables a nivel mundial. Comenzando con el arco en C m\u00f3vil PROVUE, expandiremos continuamente nuestra cartera de productos de diagn\u00f3stico de pr\u00f3xima generaci\u00f3n para mejorar a\u00fan m\u00e1s nuestra competitividad en el mercado global.<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

    Full-scale Global Launch to Begin in the Second Half of the Year DRGEM recently obtained MFDS manufacturing certification for our new PROVUE Mobile C-arm (X-ray fluoroscopy system). This key approval officially validates our advanced AI-based low-dose imaging technology. We proudly announce that this certification covers three models: PROVUE-5S, PROVUE-15S, and PROVUE-5A. The medical device fully […]<\/p>\n","protected":false},"author":8,"featured_media":11220,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[14,15],"tags":[275,298,348,89,26,349,30,347,273,37],"class_list":["post-11213","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news","category-product-updates","tag-c-arm","tag-carm","tag-denosing","tag-digitalradiography","tag-drgem","tag-healthcare","tag-medicalimaging","tag-mobile-c-arm","tag-provue","tag-radiography"],"yoast_head":"\nDRGEM AI Mobile C-arm PROVUE Wins MFDS Approval - DRGEM<\/title>\n<meta name=\"description\" content=\"DRGEM's AI PROVUE Mobile C-arm has achieved MFDS approval, marking a global launch in 2026. 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