To ensure the quality and safety of medical services in primary healthcare institutions, China’s National Health Commission (NHC) and other relevant authorities issued a notice on 1 April 2026, outlining a three-year nationwide action.
Microplate-based automatic blood grouping analyzer Metis of Aikang MedTech Co., Ltd. (henceforth referred to as Aikang) received approval for marketing in 2015; and its MGT-based automatic blood grouping analyzer Aigel received approval for marketing in 2016.
Roche announced today that the Roche Elecsys® sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the United States Food and Drug Administration (FDA). The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing. Identifying patients at high risk for severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.
GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced the initial phase of a program to improve provider access to GRAIL’s Galleri® multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest’s Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year.
QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in-vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced financial results for the fourth quarter and full-year ended December 29, 2024.
The Nasdaq Hearings Panel has decided to delist T2 Biosystems common stock after the firm failed to meet the stock exchange's requirements for the minimum bid price and market value of listed securities, T2 Biosystems said in a form filed Tuesday with the US Securities and Exchange Commission.
bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid has obtained clearance from the U.S. Food and Drug Administration (FDA). This midplex molecular panel tests for 11 of the most common bacteria, viruses, and parasites associated with gastroenteritis — all from one sample, with results available in approximately one hour.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
In vitro fertilization embryos are prone to chromosomal aneuploidy abnormalities. Chromosome aneuploidy refers to the increase or decrease in the number of a single chromosome or multiple chromosomes.
Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate Detect, an in vitro diagnostic medical device that harnesses AI to generate heatmaps identifying small and rare missed prostatic cancers, acting as a safety net that assists pathologists in ensuring patients receive an accurate diagnosis.
MRC Holland said Thursday that its blood-based assay for Temple, Kagami-Ogata, and Russell-Silver syndromes has received certification under Europe's In Vitro Diagnostic Regulation (IVDR).
Imagene, a leader in AI-powered Oncology Intelligence, today announced a collaboration with Tempus AI, Inc., a technology company leading the adoption of AI to advance precision medicine and patient care. The collaboration aims to advance cancer diagnostics by accelerating biomarker prediction, integrating AI-powered tools into clinical workflows, and enabling the commercialization of accessible diagnostic solutions.
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