Business
Noul Secures FDA Registration for Cervical Cancer Diagnostic Cartridge
Noul Co., Ltd. (CEO: David Lim), a medical AI company specializing in blood and cancer diagnostics, announced that FDA registration has been completed for its cervical cancer diagnostic cartridge miLab™ Cartridge CER and clearing agent SafeFix™ CER, both core components of the company's cervical cancer diagnostic solution miLab™ CER.
About this update from Noul Co Ltd.
[{"type":"list","items":[{"val":[{"type":"text","content":"FDA registration fulfills requirements for U.S. market entry","length":60,"tagName":"p"}]},{"val":[{"type":"text","content":"Initial shipments to Europe and Latin America to begin with pre-approved countries","length":82,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":142,"olType":false},{"type":"text","content":"YONGIN, South Korea, Sept. 23, 2025 /PRNewswire/ -- Noul Co., Ltd. (CEO: David Lim), a medical AI company specializing in blood and cancer diagnostics, announced that FDA registration has been completed for its cervical cancer diagnostic cartridge miLab™ Cartridge CER and clearing agent SafeFix™ CER, both core components of the company's cervical cancer diagnostic solution miLab™ CER.","length":396,"tagName":"p"},{"type":"image","alt":"Noul’s miLab™ platform with cervical cancer diagnostic cartridges (miLab Cartridge CER)","displaySize":"","headline":null,"caption":"Noul’s miLab™ platform with cervical cancer diagnostic cartridges (miLab Cartridge CER)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":344,"url":"https://media.zenfs.com/en/prnewswire.com/4fa7d45b78d1e3d9dbf50da43ed19ec4"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/LBL5IgivCFb1luiW6.O6MQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTYwNjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/4fa7d45b78d1e3d9dbf50da43ed19ec4","width":400,"height":344}},"href":"https://mma.prnewswire.com/media/2779326/Photo__Noul_s_miLab__platform_with_cervical_cancer_diagnostic_cartridges__miLab_Cartridge_CER.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"With this registration, Noul has fulfilled the minimum regulatory requirements for entry into the U.S. market. Beginning in October, the company will launch commercial shipments of miLab CER in Europe and Latin America, starting with countries where regulatory clearance has already been obtained.","length":297,"tagName":"p"},{"type":"text","content":"In addition to its existing miLab platform for malaria diagnostics and blood analysis, this FDA device listing provides a foothold for Noul to enter the U.S. market with its cervical cancer portfolio. The company is currently preparing phased FDA 510(k) submissions for disease-specific analysis software to be integrated into the miLab platform.","leng...