From January 2024 and June 2025, the U.S. Food and Drug Administration (FDA) approved 39 in-vitro toxicology testing products through the 510(k). This period marked a significant reshaping of the global market: Chinese companies, driven by rapid product iteration and precise market positioning, surged in the market share. At the same time, the worsening fentanyl crisis in the U.S. fueled an unprecedented demand for fentanyl testing, making it the most competitive and dynamic segment in the field.

Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for bleeding disorders and diagnosis of bleeding origins, with a relatively narrow scope of application and relatively poor accuracy.

PreAnalytiX GmbH, a joint venture between QIAGEN N.V. (NYSE: QGEN; Frankfurt, Prime Standard: QIA) and BD (Becton, Dickinson and Company; NYSE: BDX), today announced the launch of the PAXgene® Urine Liquid Biopsy Set, which enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS). The new set will be commercialized by QIAGEN.

Cepheid announced today an important partnership with the Fleming Initiative, a global collaboration established by Imperial College Healthcare NHS Trust and Imperial College London to combat antimicrobial resistance.

Molecular diagnostics uses human saliva, tissue, blood, feces, urine, and other samples to detect disease-related markers and provides experimental diagnostic results for medical professionals in disease prevention, screening, diagnosis, stratification, prognosis, and efficacy monitoring.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today at the North American Spine Society (NASS) 39th Annual Meeting in Chicago the commercial launch of several software, hardware, and imaging innovations. These enhancements are designed to advance AiBLE™, the Medtronic smart ecosystem of innovative navigation, robotics, data and AI, imaging, software and implants that enable more predictable outcomes in spine and cranial procedures. In line with its commitment to increasing the quality of care for patients with spinal conditions, Medtronic also announced a partnership with Siemens Healthineers to explore opportunities to further expand access to advanced pre- and post-operative imaging technologies for spine care.

The US Food and Drug Administration said Tuesday that it plans to reclassify several types of qualitative and quantitative hepatitis B virus (HBV) tests as moderate risk Class II devices from their current classification as high-risk Class III devices.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the cobas® Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology.

At present, the upstream raw materials of biochemical reagents mainly rely on imports. For the long-term development of the industry, the preparation technology of raw materials must be mastered.

Bio-Rad Laboratories announced Friday that it has formed a partnership with Sysmex America to offer Bio-Rad's quality control software with Sysmex's hemostasis analyzers for coagulation testing.

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

Thermo Fisher Scientific, headquartered in Massachusetts, announced that it will open a new bioanalytical laboratory in GoCo Health Innovation City, located in Gothenburg, Sweden. The new building, situated adjacent to AstraZeneca's key research location, will improve the company's laboratory services.