{"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\/ja\/drgem-provue-mobile-c-arm-mfds-approval\/","title":{"rendered":"AI\u30e2\u30d0\u30a4\u30ebC\u30a2\u30fc\u30e0\u300cPROVUE\u300d\u3001MFDS\u627f\u8a8d\u53d6\u5f97"},"content":{"rendered":"

\u5e74\u5f8c\u534a\u306b\u672c\u683c\u7684\u306a\u30b0\u30ed\u30fc\u30d0\u30eb\u30ed\u30fc\u30f3\u30c1\u3092\u958b\u59cb<\/strong><\/h3>\n\n\n\n
\n
\"\"<\/figure>\n\n\n\n
    \n
  • KAIST\u3068\u306e\u5171\u540c\u7814\u7a76\u306b\u3088\u308b\u3001\u533b\u7642\u5f93\u4e8b\u8005\u304a\u3088\u3073\u60a3\u8005\u306e\u653e\u5c04\u7dda\u88ab\u3070\u304f\u7dda\u91cf\u4f4e\u6e1b\u306b\u8cc7\u3059\u308b\u30ce\u30a4\u30ba\u9664\u53bb\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u958b\u767a<\/li>\n\n\n\n
  • \u4eca\u5e74\u4e0b\u534a\u671f\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30ed\u30fc\u30f3\u30c1\u3092\u76ee\u6307\u3057\u3001\u30e2\u30d0\u30a4\u30eb\u753b\u50cf\u8a3a\u65ad\u88c5\u7f6e\u306e\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u62e1\u5145<\/li>\n<\/ul>\n\n\n\n

    DRGEM\u306f\u5148\u3054\u308d\u3001\u65b0\u88fd\u54c1\u300cPROVUE Mobile C-arm\u300d\uff08X\u7dda\u900f\u8996\u30b7\u30b9\u30c6\u30e0\uff09\u306b\u3064\u3044\u3066\u3001MFDS\u306e\u88fd\u9020\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u91cd\u8981\u306a\u627f\u8a8d\u306b\u3088\u308a\u3001\u5f53\u793e\u306e\u5148\u9032\u7684\u306aAI\u30d9\u30fc\u30b9\u306e\u4f4e\u7dda\u91cf\u753b\u50cf\u6280\u8853\u304c\u6b63\u5f0f\u306b\u8a8d\u3081\u3089\u308c\u307e\u3057\u305f\u3002.<\/p>\n\n\n\n

    PROVUE-5S\u3001PROVUE-15S\u3001PROVUE-5A \u306e 3 \u30e2\u30c7\u30eb\u304c\u672c\u8a8d\u8a3c\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3053\u3068\u3092\u8a87\u308a\u3092\u3082\u3063\u3066\u767a\u8868\u3044\u305f\u3057\u307e\u3059\u3002\u672c\u533b\u7642\u6a5f\u5668\u306f\u3001\u3059\u3079\u3066\u306e\u898f\u5236\u4e0a\u306e\u5b89\u5168\u304a\u3088\u3073\u54c1\u8cea\u8981\u4ef6\u306b\u5b8c\u5168\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u516c\u5f0f\u306a\u8a8d\u8a3c\u306f\u3001\u56fd\u5185\u5916\u306e\u5e02\u5834\u3078\u306e\u4e8b\u696d\u62e1\u5927\u306b\u5411\u3051\u305f\u5f37\u56fa\u306a\u57fa\u76e4\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

    KAIST\u3068\u306e\u5171\u540c\u7814\u7a76\u306b\u3088\u308b\u30ce\u30a4\u30ba\u9664\u53bb\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u958b\u767a<\/h3>\n\n\n\n

    \u624b\u8853\u4e2d\u3001\u53ef\u52d5\u5f0fC\u30a2\u30fc\u30e0\u30b7\u30b9\u30c6\u30e0\u306fX\u7dda\u3092\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u3067\u4f7f\u7528\u3057\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u9bae\u660e\u306a\u753b\u50cf\u3092\u63d0\u4f9b\u3057\u3064\u3064\u3001\u653e\u5c04\u7dda\u88ab\u3070\u304f\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002DRGEM\u306f\u3001PROVUE\u30e2\u30d0\u30a4\u30ebC\u30a2\u30fc\u30e0\u306b\u9ad8\u6027\u80fd\u306aAI\u30d9\u30fc\u30b9\u306e\u753b\u50cf\u51e6\u7406\u30a8\u30f3\u30b8\u30f3\u3092\u642d\u8f09\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30a8\u30f3\u30b8\u30f3\u306b\u3088\u308a\u3001\u4f4e\u96fb\u5727\u30fb\u4f4e\u96fb\u6d41\u74b0\u5883\u4e0b\u3067\u3082\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u900f\u8996\u64ae\u5f71\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002 \u3053\u306e\u6280\u8853\u306b\u3088\u308a\u3001\u533b\u7642\u30b9\u30bf\u30c3\u30d5\u3084\u60a3\u8005\u3078\u306e\u653e\u5c04\u7dda\u88ab\u3070\u304f\u306e\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002\u540c\u6642\u306b\u3001\u6b63\u78ba\u306a\u8a3a\u65ad\u306b\u5fc5\u8981\u306a\u512a\u308c\u305f\u753b\u8cea\u3082\u78ba\u4fdd\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

    \u5177\u4f53\u7684\u306b\u306f\u3001KAIST\u3068\u306e\u5171\u540c\u7814\u7a76\u3067\u958b\u767a\u3055\u308c\u305f\u65b0\u3057\u3044\u30ce\u30a4\u30ba\u9664\u53bb\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3092\u9069\u7528\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306f\u3001\u4f4e\u7dda\u91cf\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u6642\u306e\u753b\u50cf\u30ce\u30a4\u30ba\u3092\u52b9\u679c\u7684\u306b\u9664\u53bb\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u653e\u5c04\u7dda\u91cf\u3092\u4f4e\u6e1b\u3057\u306a\u304c\u3089\u3082\u3001\u9bae\u660e\u3067\u30af\u30ea\u30a2\u306aX\u7dda\u753b\u50cf\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u30d6\u30ec\u30fc\u30af\u30b9\u30eb\u30fc\u306f\u3001\u5f53\u793e\u306eX\u7dda\u900f\u8996\u5e02\u5834\u306b\u304a\u3051\u308b\u6280\u8853\u7684\u30ea\u30fc\u30c0\u30fc\u30b7\u30c3\u30d7\u3092\u5f37\u5316\u3059\u308b\u3082\u306e\u3068\u306a\u308b\u3067\u3057\u3087\u3046\u3002.<\/p>\n\n\n\n

    \u30b0\u30ed\u30fc\u30d0\u30eb\u30d8\u30eb\u30b9\u30b1\u30a2\u5e02\u5834\u3078\u306e\u98db\u8e8d<\/h3>\n\n\n\n

    PROVUE\u30e2\u30d0\u30a4\u30ebC\u30a2\u30fc\u30e0\u306e\u56fd\u5185\u88fd\u9020\u8a8d\u8a3c\u53d6\u5f97\u306f\u3001\u610f\u7fa9\u6df1\u3044\u7bc0\u76ee\u3068\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u6210\u679c\u306f\u3001DRGEM\u306e\u5148\u9032\u7684\u306a\u753b\u50cf\u51e6\u7406\u6280\u8853\u3068\u5f37\u529b\u306a\u5e02\u5834\u7af6\u4e89\u529b\u3092\u6539\u3081\u3066\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u6210\u529f\u3092\u8db3\u639b\u304b\u308a\u306b\u3001\u5f53\u793e\u306f\u73fe\u5728\u30012026\u5e74\u4e0b\u534a\u671f\u306b\u4e16\u754c\u5e02\u5834\u3078\u6b63\u5f0f\u306b\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u6295\u5165\u3067\u304d\u308b\u3088\u3046\u3001\u91cf\u7523\u306b\u5411\u3051\u305f\u6e96\u5099\u3092\u52a0\u901f\u3055\u305b\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

    \u7d99\u7d9a\u7684\u306a\u7814\u7a76\u958b\u767a\u3068\u54c1\u8cea\u9769\u65b0\u3092\u901a\u3058\u3066\u3001\u4e16\u754c\u3067\u3088\u308a\u5b89\u5168\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u533b\u7528\u753b\u50cf\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002PROVUE\u30e2\u30d0\u30a4\u30ebC\u30a2\u30fc\u30e0\u304b\u3089\u59cb\u3081\u3001\u6b21\u4e16\u4ee3\u8a3a\u65ad\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3092\u7d99\u7d9a\u7684\u306b\u62e1\u5927\u3057\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3067\u306e\u7af6\u4e89\u529b\u3092\u3055\u3089\u306b\u9ad8\u3081\u3066\u3044\u304d\u307e\u3059\u3002.<\/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 complies with all regulatory safety and quality requirements. This official recognition lays a solid foundation for our expansion into both domestic and global markets. Development of a denoising algorithm based on joint research with KAIST During surgical procedures, a mobile C-arm system uses X-rays in real time. Therefore, the system must minimize radiation exposure while […]<\/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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