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

Implementation of in Vitro Diagnosis of Thrombosis and Hemostasis in the Chinese Market

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

China enacted new measures, effective immediately, targeting the procurement of certain medical devices imported from the European Union in government purchasing programs, according to a notice issued by the Ministry of Finance on Sunday.

Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal’s ZEGFROVY® (sunvozertinib) and in tumor profiling. This approval brings rapid next-generation sequencing (NGS) to decentralized clinical settings closer to where patients receive care. With the ability to deliver essential genomic insights in as little as 24 hours*, this approval helps advance the accessibility of precision oncology tools and enables more timely decision making.

The TOBY Test has received breakthrough device designation from the FDA for the early detection of bladder cancer. This designation underscores the significant potential of this innovative urine-based assay to fundamentally alter the landscape of bladder cancer detection and surveillance, offering a much-needed non-invasive alternative to current diagnostic paradigms.

Merck, a leading science and technology company, today announced that it has closed the acquisition of SpringWorks Therapeutics, Inc., for an enterprise value of $3.4 billion (approximately €3 billion)*, following regulatory clearances and the fulfillment of other customary closing conditions.

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.