{"id":9730,"date":"2025-01-16T17:53:16","date_gmt":"2025-01-16T08:53:16","guid":{"rendered":"https:\/\/rightfoundation.kr\/en\/?p=9730"},"modified":"2025-05-08T15:19:28","modified_gmt":"2025-05-08T06:19:28","slug":"nouls-milab-first-product-listing-completed-with-us-fda","status":"publish","type":"post","link":"https:\/\/rightfoundation.kr\/en\/nouls-milab-first-product-listing-completed-with-us-fda\/","title":{"rendered":"Noul&#8217;s miLab, First Product Listing Completed with US FDA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9730\" class=\"elementor elementor-9730\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-22110e80 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"22110e80\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7581e584\" data-id=\"7581e584\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-79c9ffeb elementor-widget elementor-widget-stad_for_elementor_heading\" data-id=\"79c9ffeb\" data-element_type=\"widget\" data-widget_type=\"stad_for_elementor_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\r\n\t<div class=\"stad-heading stad-heading-single-content stad-padding-0 stad-margin-0\">\t\t<span class=\"stad-heading-single-content-text stad-heading-content-text stad-inline-block\">\r\n\t\t\t\t\t\t\t<span class=\"stad-heading-single-content-text-content\">Noul's miLab, US Market Expansion in Full Swing\u2219\u2219\u2219First Product Listing Completed with US FDA<\/span>\r\n\t\t\t\t\t<\/span>\r\n\t<\/div>\t\r\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c9be6c elementor-widget elementor-widget-stad_for_elementor_heading\" data-id=\"5c9be6c\" data-element_type=\"widget\" data-widget_type=\"stad_for_elementor_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\r\n\t<div class=\"stad-heading stad-heading-single-content stad-padding-0 stad-margin-0\">\t\t<span class=\"stad-heading-single-content-text stad-heading-content-text stad-inline-block\">\r\n\t\t\t\t\t\t\t<span class=\"stad-heading-single-content-text-content\">The RIGHT Foundation has been supporting Noul\u2019s diagnostic device, miLab, since 2020 through the project titled \"AI-driven all-in-one diagnostic platform for malaria species differentiation\" A total of 4.3 billion KRW in funding will be provided by 2026.<\/span>\r\n\t\t\t\t\t<\/span>\r\n\t<\/div>\t\r\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4350ca7 elementor-widget elementor-widget-stad_for_elementor_classic_list\" data-id=\"4350ca7\" data-element_type=\"widget\" data-widget_type=\"stad_for_elementor_classic_list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"stad-classic-list-container stad-flex\"><ul class=\"stad-classic-list stad-list stad-classic-block-list\">\t\t\t<li class=\"stad-classic-list-item elementor-repeater-item-c61186b\">\r\n\t\t\t\t\t\t\t\t\tPre-registration underway for upcoming contracts with US clients currently under discussion... Expecting significant expansion with US clients.\t\t\t\t\t\t\t\t\t\t\t\t<\/li>\r\n\t\t\t\t\t\t<li class=\"stad-classic-list-item elementor-repeater-item-8bd58a6\">\r\n\t\t\t\t\t\t\t\t\tFDA approval procedures for miLab solutions are progressing smoothly... \u201cWe aim to become a global leader in blood and cancer diagnostics through successful entry into the US market.\u201d\t\t\t\t\t\t\t\t\t\t\t\t<\/li>\r\n\t\t\t<\/ul><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4375b8 elementor-widget elementor-widget-image\" data-id=\"c4375b8\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.1 - 02-04-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"490\" height=\"334\" src=\"https:\/\/rightfoundation.kr\/en\/wp-content\/uploads\/sites\/2\/2025\/01\/milab.png\" class=\"attachment-large size-large wp-image-9733\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/rightfoundation.kr\/en\/wp-content\/uploads\/sites\/2\/2025\/01\/milab.png 490w, https:\/\/rightfoundation.kr\/en\/wp-content\/uploads\/sites\/2\/2025\/01\/milab-460x314.png 460w, https:\/\/rightfoundation.kr\/en\/wp-content\/uploads\/sites\/2\/2025\/01\/milab-450x307.png 450w, https:\/\/rightfoundation.kr\/en\/wp-content\/uploads\/sites\/2\/2025\/01\/milab-350x239.png 350w\" sizes=\"(max-width: 490px) 100vw, 490px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4161c14 elementor-widget elementor-widget-text-editor\" data-id=\"4161c14\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.1 - 02-04-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>November 28, 2024 \u2013 Noul Co., Ltd. (CEO David Lim, hereinafter &#8216;Noul&#8217;) announced that it has completed establishment registration and device listing for four of its medical device products (miLab\u2122 Platform, miLab\u2122 Cartridge MAL, miLab\u2122 Cartridge BCM, SafeFix\u2122) with the U.S. Food and Drug Administration (FDA).<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8f94986 elementor-widget elementor-widget-text-editor\" data-id=\"8f94986\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Currently, Noul is smoothly progressing through each stage of the FDA approval process for its miLab solutions as part of its full-scale entry into the US market.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50f4f94 elementor-widget elementor-widget-text-editor\" data-id=\"50f4f94\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>David Lim, CEO of Noul, stated, \u201cThis registration was completed in advance for upcoming contracts with US clients currently under discussion. We are very pleased to have taken the first step towards our US market entry by completing the first FDA registration for the miLab platform, which forms the foundation of all our diagnostic products.\u201d He added, \u201cWe will accelerate the FDA approval process for all Noul products, successfully leading our entry into the US market, and further expand globally to become a world-leading company specializing in blood and cancer diagnostics.\u201d<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f664717 elementor-widget elementor-widget-text-editor\" data-id=\"f664717\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>This registration is an important step in proving that Noul&#8217;s products meet the stringent quality control and safety standards set by the US FDA, and it holds great significance as it marks the official commencement of Noul\u2019s entry into the US market. Through this registration, Noul has fulfilled the legal requirements for the distribution and use of its products in the US, further enhancing its product competitiveness and credibility in the global market.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-709be5c elementor-widget elementor-widget-text-editor\" data-id=\"709be5c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>The listed products include Noul\u2019s automated diagnostic device, the \u2018miLab\u2122 Platform\u2019, which incorporates solid staining and imaging technologies, along with two diagnostic cartridges for malaria and blood analysis (miLab\u2122 Cartridge MAL and miLab\u2122 Cartridge BCM), and the fixation solution (SafeFix\u2122). These products form the core platform that underpins Noul\u2019s diagnostic solutions, with analysis software for applications such as malaria, blood analysis, and cervical cancer added to further enhance their diagnostic capabilities.<br \/><br \/>The U.S. in vitro diagnostics market is expected to grow at a compound annual growth rate (CAGR) of 7.7%, from approximately $36.35 billion in 2023 to $61.13 billion by 2030. The market is growing faster than expected, driven by factors such as the aging population, increased prevalence of chronic diseases, and heightened awareness of early disease diagnosis. In line with this market growth, Noul plans to accelerate its entry into the U.S. market.<br \/><br \/>Meanwhile, Noul recently supplied its AI-based blood analysis solution \u2018miLab\u2122 BCM\u2019 to major hospitals and screening centers in Italy, marking its first sales of miLab\u2122 BCM in European countries. This supply came as a result of additional purchases following the earlier delivery of the malaria diagnostic solution \u2018miLab\u2122 MAL\u2019 to Italy earlier this year. The excellent performance and reliability of the previously supplied products played a crucial role in this additional purchase.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7b42229c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7b42229c\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-1a79e19b\" data-id=\"1a79e19b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-217a68c1\" data-id=\"217a68c1\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5749a4b7 elementor-align-right elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"5749a4b7\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a href=\"\/en\/partner-news\/\" class=\"elementor-button-link elementor-button elementor-size-sm\" role=\"button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Partner News List<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-54a5a5cf elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"54a5a5cf\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-341b078a\" data-id=\"341b078a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Noul&#8217;s miLab, US Market Expansion in Full Swing\u2219\u2219\u2219First Product Listing Completed with US FDA The RIGHT Foundation has been supporting Noul\u2019s diagnostic device, miLab, since 2020 through the project titled &#8220;AI-driven all-in-one diagnostic platform for malaria species differentiation&#8221; A total of 4.3 billion KRW in funding will be provided by 2026. Pre-registration underway for upcoming&#8230;<\/p>\n","protected":false},"author":1,"featured_media":10179,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[9],"tags":[],"jetpack_featured_media_url":"https:\/\/rightfoundation.kr\/en\/wp-content\/uploads\/sites\/2\/2025\/01\/\ub178\uc744.png","_links":{"self":[{"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/posts\/9730"}],"collection":[{"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/comments?post=9730"}],"version-history":[{"count":14,"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/posts\/9730\/revisions"}],"predecessor-version":[{"id":10180,"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/posts\/9730\/revisions\/10180"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/media\/10179"}],"wp:attachment":[{"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/media?parent=9730"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/categories?post=9730"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rightfoundation.kr\/en\/wp-json\/wp\/v2\/tags?post=9730"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}