With the development of artificial intelligence technology, it plays an important role in laboratory medicine, especially in the automatic identification of cell morphology. The new generation of AI technology shows the characteristics of deep learning, autonomous learning, human-machine collaboration, and so on.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
altona Diagnostics today announced that its FlexStar® STI panel has obtained CE marking under Regulation (EU) 2017/746 (IVDR). This completes the IVDR transition for the company’s modular and adaptive STI testing portfolio, enabling laboratories to configure customizable multiplex panels for up to 7 sexually transmitted pathogens in a single sample.
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers, today announced the closing of the previously announced sale of its Lab Products business to Eurobio Scientific. The transaction closed on June 30, 2026 following receipt of required Swedish regulatory clearance.
The chair of the U.S. House Select Committee on China opened national security investigations into whether five drugmakers including Merck (MRK.N), opens new tab and AbbVie (ABBV.N), opens new tab have been involved in clinical trials conducted in China that helped fuel the communist country's military capability.
The U.S. Department of Health and Human Services (HHS) today announced that Secretary Robert F. Kennedy, Jr. has signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs and biological products and for medical devices, concluding that the circumstances that justified these emergency authorities no longer exist.
bioMérieux, a world leader in the field of in vitro diagnostics, has submitted a Dual 510(k)/CLIA Waiver* application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel**. This automated, multiplex PCR*** test can simultaneously detect the most common causes of vaginitis in 20 minutes, directly at the point of care. With this submission, bioMérieux is intending to expand into women’s and sexual health, bringing rapid and accurate diagnostics closer to patients.
Genedrive (LSE:GDR) has entered into a collaboration agreement with Thermo Fisher Scientific to develop the Genedrive CYP2C19 HT Kit, a high-throughput pharmacogenetic in vitro diagnostic test designed for use on Thermo Fisher’s QuantStudio 5 Dx PCR platform. The new assay is aimed at centralised laboratory testing and complements the company’s existing rapid CYP2C19 ID Kit for near-patient use. Genedrive is targeting UKCA certification by the end of 2026, with the initial commercial focus on NHS genomic laboratories across the UK.
The major brands in China’s urinalysis market are URIT, DIRUI, AVE, etc. URIT produced China’s first urine analyzer in 1984. And after nearly 40 years’ strenuous cultivation, it pioneered the modular urine analysis workflow using deep learning artificial intelligence (AI) image recognition technology.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the closing of its previously announced equity financing with Samsung affiliates including Samsung C&T Corporation.
A diagnostics company behind one of the best-known rapid Covid-19 tests has put its point-of-care testing unit up for sale, aiming at a valuation of $1.5bn, as private equity buyers eye opportunities in the healthcare and life sciences sectors.
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