Mindray blood cell analysis research and development team launched this product based on stable, accurate and reliable quality.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") today announced its financial results for the second quarter of fiscal year 2026.
Intelligenome and Cornell University entered into a research and development subaward agreement to support the development of a rapid, low-cost, and portable diagnostic solution for tuberculosis (TB), according to the company. The project is part of a National Institutes of Health (NIH) funded program focused on improving access to technologies for human healthcare.
Alveo Technologies, Inc. (Alveo), a leader in portable molecular sensing solutions, today announced a strategic partnership with The University of Texas Medical Branch (UTMB) to develop point-of-care diagnostics for viral hemorrhagic fevers across West Africa. The point-of-care diagnostic will provide real-time pathogen detection at clinical sites in Nigeria and Sierra Leone, supporting UTMB's Lassa fever research program—a major international initiative.
bioMérieux, a world leader in the field of in vitro diagnostics, today announces the submission of the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid to the U.S. Food and Drug Administration (FDA) for 510(k) review. These PCR* molecular panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis, all from one sample, with results available in approximately one hour.
Produced by DIRUI, it can meet the needs of intelligent, automated, and high-throughput urine dry chemical test in hospitals.
The Association for Diagnostics & Laboratory Medicine (ADLM) 2026 Annual Meeting — Waters Corporation (NYSE: WAT) today announced the launch of the Xevo TQ Absolute XR IVD Mass Spectrometer, expanding its MassTrak™ IVD System portfolio of LC-MS/MS Systems with a solution that combines class-leading sensitivity and enhanced robustness for clinical applications. The new system builds on the industry-renowned step-change performance of the Xevo TQ Absolute IVD Mass Spectrometer, which established the benchmark for sensitivity among IVD-compliant tandem quadrupole mass spectrometers.
The U.S. FDA has approved Freenome's (FRNM.O), opens new tab blood-based colorectal cancer screening test for older adults, paving the way for partner Abbott (ABT.N), opens new tab to launch it in the U.S. this fall, the companies said on Monday.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Ibex Medical Analytics (Ibex), the global leader in AI-powered pathology solutions for clinical diagnostics and biopharma, today announced that it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for Ibex Breast ER, PR and Ki67. This milestone solidifies Ibex’s position as the market leader in breast cancer diagnostics by rounding out regulatory approval for its entire breast portfolio, which delivers unprecedented value to pathologists, laboratories, and patients. Covering biopsies and excisions, the breast suite comprises a fully IVDR-certified, end-to-end workflow across H&E, HER2, ER, PR, and Ki67-stained whole slide images. This was achieved following clinical studies and a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It enables accurate and timely results that can lead to improved patient outcomes and enhanced healthcare efficiencies.
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