{"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\/id\/drgem-provue-mobile-c-arm-mfds-approval\/","title":{"rendered":"AI Mobile C-arm PROVUE Raih Persetujuan MFDS"},"content":{"rendered":"<h3 id=\"h-full-scale-global-launch-to-begin-in-the-second-half-of-the-year\" class=\"wp-block-heading\"><strong>Peluncuran Global Skala Penuh Akan Dimulai di Semester Kedua Tahun Ini<\/strong><\/h3>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-9f0220d1 wp-block-group-is-layout-constrained\">\n<figure class=\"wp-block-image size-large\" style=\"margin-top:50px;margin-bottom:50px\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"768\" src=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/07\/DRGEM_\ubcf4\ub3c4\uc790\ub8cc_PROVUE_260706-1024x768.png\" alt=\"\" class=\"wp-image-11214\" srcset=\"\" sizes=\"(max-width: 1024px) 100vw, 1024px\" data-srcset=\"\" \/><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pengembangan algoritma denoising berdasarkan riset bersama dengan KAIST, mengurangi beban paparan radiasi bagi staf medis dan pasien<\/li>\n\n\n\n<li style=\"margin-bottom:50px\">Mendorong peluncuran global pada paruh kedua tahun ini, memperluas portofolio peralatan pencitraan diagnostik seluler<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">DRGEM baru-baru ini memperoleh sertifikasi produksi dari MFDS untuk produk terbaru kami, PROVUE Mobile C-arm (sistem fluoroskopi sinar-X). Persetujuan penting ini secara resmi mengukuhkan keunggulan teknologi pencitraan dosis rendah berbasis kecerdasan buatan (AI) kami.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"margin-bottom:50px\">Kami dengan bangga mengumumkan bahwa sertifikasi ini mencakup tiga model: PROVUE-5S, PROVUE-15S, dan PROVUE-5A. Alat kesehatan ini sepenuhnya mematuhi semua persyaratan keselamatan dan kualitas peraturan. Pengakuan resmi ini menjadi landasan yang kuat bagi ekspansi kami ke pasar domestik dan global.<\/p>\n\n\n\n<h3 id=\"h-development-of-a-denoising-algorithm-based-on-joint-research-with-kaist\" class=\"wp-block-heading\">Pengembangan algoritma peredam bising berdasarkan penelitian bersama dengan KAIST<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Selama prosedur bedah, sistem C-arm portabel menggunakan sinar-X secara real-time. Oleh karena itu, sistem tersebut harus meminimalkan paparan radiasi sekaligus menghasilkan gambar yang jelas. DRGEM menerapkan mesin pencitraan berbasis AI yang canggih pada PROVUE Mobile C-arm. Mesin ini memungkinkan pencitraan fluoroskopi real-time bahkan dalam lingkungan dengan tegangan dan arus rendah. Teknologi ini mengurangi beban radiasi bagi tenaga medis dan pasien. Pada saat yang sama, teknologi ini memastikan kualitas gambar yang sangat baik untuk diagnosis yang akurat.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"margin-bottom:50px\">Secara spesifik, kami menerapkan algoritma penghilangan derau (denoising) baru yang dikembangkan melalui riset gabungan dengan KAIST. Algoritma ini secara efektif menghilangkan derau citra selama pencitraan dosis rendah. Hal ini menurunkan dosis radiasi total sambil menghasilkan citra sinar-X yang tajam dan jelas. Terobosan ini akan memperkuat kepemimpinan teknologi kami di pasar fluoroskopi.<\/p>\n\n\n\n<h3 id=\"h-leaping-forward-into-the-global-healthcare-market\" class=\"wp-block-heading\">Melompat Maju ke Pasar Kesehatan Global<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\" id=\"h-leaping-forward-into-the-global-healthcare-market\">Sertifikasi produksi dalam negeri untuk PROVUE Mobile C-arm merupakan tonggak penting yang berarti. Prestasi ini sekali lagi membuktikan keunggulan teknologi pemrosesan gambar DRGEM serta daya saingnya yang kuat di pasar. Berbekal kesuksesan ini, kami kini mempercepat persiapan produksi massal untuk secara resmi memperkenalkan sistem ini ke pasar global pada paruh kedua tahun 2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" id=\"h-leaping-forward-into-the-global-healthcare-market\" style=\"margin-bottom:50px\">Melalui riset berkelanjutan dan inovasi berkualitas, kami akan menyediakan solusi pencitraan medis yang lebih aman dan andal di seluruh dunia. Dimulai dengan PROVUE Mobile C-arm, kami akan terus memperluas portofolio produk diagnostik generasi berikutnya untuk lebih meningkatkan daya saing kami di pasar global.<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>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 [&hellip;]<\/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":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DRGEM AI Mobile C-arm PROVUE Wins MFDS Approval - DRGEM<\/title>\n<meta name=\"description\" content=\"DRGEM&#039;s AI PROVUE Mobile C-arm has achieved MFDS approval, marking a global launch in 2026. 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