LumiraDx Limited (Nasdaq: LMDX), a leading innovator in diagnostic technologies, today announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its ground-breaking 5-minute COVID Ultra Test. LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.
Helio Genomics said Thursday that its sister company, Laboratory for Advanced Medicine & Health Group (LAMH), has received approval from the National Medical Products Administration (NMPA) in China for its cell-free DNA-based liver cancer detection test. The assay is the first of its kind to receive this approval.
At 9:30 a.m. on June 30, Adicon was officially listed on the Hong Kong Stock Exchange. Adicon Holdings (09860.HK) is offering 33,192,500 shares globally, of which 3,320,000 shares are offered in Hong Kong, China and 29,872,500 shares are offered internationally, with a 15% over-allotment option.
Eli Lilly and Company (NYSE: LLY) and Sigilon Therapeutics, Inc. (Nasdaq: SGTX) today announced a definitive agreement for Lilly to acquire Sigilon, a biopharmaceutical company that seeks to develop functional cures for patients with a broad range of acute and chronic diseases.
ARUP Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved AAV5 DetectCDx™ as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIAN™ (valoctocogene roxaparvovec-rvox).
Based on the advantages of their respective fields, the two companies will carry out in-depth cooperation in life information and support, in vitro diagnosis, medical imaging, overall solutions for two cancer screening, hospital department equipment, information construction, etc., and jointly establish the "Hybribio-Mindray Standardized Laboratory" to achieve complementary advantages and resource sharing.
Bio-Techne announced on Thursday that it is acquiring Swiss spatial biology firm Lunaphore for an undisclosed amount.
PamGene International said Tuesday that the European Innovation Council's Accelerator program will provide €7.5 million ($8.2 million) in funding to develop and market the firm's prognostic test for immunotherapy response in metastatic cancer treatment.
In some areas with weak medical resources in China, it is difficult for the public to obtain quality medical services and have to seek treatment across provinces and regions, which is a heavy economic and time burden.
MOROCCO – Techniques Science Santé (T2S), a distributor of high-tech medical equipment based in Casablanca, has expanded a multi-year agreement with American company GE Healthcare, with a focus on ultra-modern modern technology.
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