Molecular diagnosis is performed at the gene level with nucleic acids as the object for detection, with high sensitivity and accuracy.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform’s continuous innovation and PathAI’s commitment to delivering enhanced capabilities as the product evolves.

Microsoft has built an artificial intelligence-powered medical tool it claims is four times more successful than human doctors at diagnosing complex ailments, as the tech giant unveils research it believes could speed up treatment.

MGI Tech Co., Ltd. (MGI), a company dedicated to developing core tools and technologies that drive innovation in life sciences, today announced a partnership with Negedia, an initiative born from Fondazione Telethon to expand access to DNBSEQ™-powered genomic sequencing and Stereo-seq spatial transcriptomics for precision medicine and biomedical research in Italy.

RetinalGenix Technologies Inc. OTCQB:RTGN (“RetinalGenix” or the “Company”), a pioneering developmental-stage company focused on ophthalmic screening, monitoring, pharmacogenetic mapping, and repurposed drug development for early detection and treatment of eye and systemic diseases, has entered into an agreement with LabCorp, one of the nation’s largest laboratory services organizations, to support the rollout of the RetinalGenix DNA/RNA/GPS Pharmaco-Genetic Mapping™ platform. This innovative program enables patients to undergo genetic testing and high-resolution retinal imaging anonymously and provide insights into both ocular and systemic diseases.

Sysmex America, Inc., a leading diagnostic solutions company offering hematology, hemostasis, urinalysis, flow cytometry and informatic solutions, has received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer. This clearance includes the reagent products used in five commonly performed hemostasis tests:

Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its high-volume TrinScreen™ HIV rapid test, a cornerstone diagnostic product used in HIV screening programs. This regulatory approval marks a critical milestone in the Company’s comprehensive transformation plan aimed at restoring financial performance and driving sustainable profitability.

Microfluidic chip technology integrates basic operational units such as sample preparation, reaction, analysis, and detection, harnessing techniques from the fields of chemistry and biology into a chip of several square centimeters, automatically completing the entire analysis process.

Illumina, Inc. (NASDAQ: ILMN) announced today it has entered into a definitive agreement with Standard BioTools (NASDAQ: LAB) under which Illumina will acquire SomaLogic, a leader in data-driven proteomics technology, and other specified assets for $350 million in cash payable at closing, subject to customary adjustments, plus up to $75 million in near-term performance-based milestones and performance-based royalties.