Different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Mirxes, a leading RNA technology company specializing in early cancer detection and precision medicine, today announced a US$40 million structured financing transaction with CBC Group’s R-Bridge Healthcare Fund (“R-Bridge”). This partnership will provide critical support for Mirxes’ ambitious growth and expansion into key global markets.
Revvity, Inc. (NYSE: RVTY), today announced a strategic agreement to commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing, co-developed with Element Biosciences, Inc., a life science company democratizing access to advanced DNA and multi-omic sequencing solutions. This initiative builds upon Revvity's recent introduction of an automated next-generation sequencing (NGS) workflow for newborn sequencing research and strengthens Element’s momentum towards regulatory approval of the benchtop AVITI™ sequencing system.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Werfen today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents.
bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has entered into an agreement to acquire SpinChip Diagnostics ASA (“SpinChip”), a privately held Norwegian diagnostics company that has developed a game-changing immunoassay diagnostics platform. The small benchtop analyzer is well adapted to near patient testing as it can deliver a result from a whole blood sample within 10 minutes with the same high-sensitivity performance as the laboratory instruments. bioMérieux has held a minority stake in SpinChip since March 2024.
Lymphoma, also known as malignant lymphoma, is a general term for a group of malignant tumors originating from the lymphopoietic system. It is one of the most common tumors in China. In 2020, there were 544,352 new cases of non-Hodgkin lymphoma (NHL) worldwide, ranking 13th among all new cases of malignancies.
Bosch Healthcare Solutions has obtained CE-IVDR marking for its Vivalytic Bacterial Meningitis PCR test running on the company's fully automated Vivalytic analysis platform.
Revvity, Inc. (NYSE: RVTY), today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the United States Food and Drug Administration (FDA). This clearance modifies the one Roche received on June 14, 2024 for Roche Digital Pathology Dx, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, and now adds the VENTANA DP 600 slide scanner.
Danaher Diagnostics LLC and Danaher Ventures LLC, two subsidiaries of Danaher Corporation (NYSE: DHR) ("Danaher"), a global science and technology innovator, announced today that they have formed an investment partnership with Innovaccer Inc., a leading healthcare artificial intelligence (AI) company.
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