Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling.

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced the acquisition of Paige, an AI company specializing in digital pathology. The acquisition allows Tempus to grow its dataset, expand its experienced technical team, and establish a strong footprint in digital pathology with an industry leading technology portfolio.

Roche Takes Key Step in Localization Strategy: First Import-to-Local Production Project Achieves Product Registration in China Roche Diagnostics has obtained product registration in China ..

Ant Group has announced a strategic partnership with Peking University Third Hospital in Beijing to establish a joint AI healthcare innovation laboratory.

Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced the New York State Department of Health (NYSDOH) has granted the Quanterix Accelerator Laboratory a clinical laboratory permit in the Clinical Chemistry category. The permit approval expands advanced biomarker research led by Quanterix, deepening collaborations with clinical, pharmaceutical, and research partners. The Quanterix Accelerator Lab is now fully CLIA-certified in all 50 states, enabling comprehensive clinical testing and biomarker analysis nationwide.

PathAI, a global leader in artificial intelligence and digital pathology solutions, and Moffitt Cancer Center, one of the nation’s top cancer hospitals and a leader in cancer research, today announced a multi-year strategic collaboration to deploy PathAI’s digital pathology platform, AISight® Dx, across Moffitt’s pathology programs to transform cancer detection and innovation.

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 the completion of a series of related transactions to refinance its debt structure and support future growth. Through these transactions, the Company extended its debt maturities and reduced required amortization payments.

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: Chines..

Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HCV VL Fingerstick, an HCV RNA test that detects and quantifies HCV directly from a drop of blood, simplifying the diagnostic pathways to speed up linkage to care and monitoring sustained virological response. Xpert HCV VL Fingerstick test is performed on the GeneXpert® system.

Agilent Technologies Inc. (NYSE: A) today announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer. This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo® (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy® (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced financial results for its second quarter ended June 30, 2025 and updated its financial guidance on business performance for the full-year 2025.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its first quarter (Q1) of fiscal year 2026 (FY26), which ended July 25, 2025.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection of the amyloid plaques associated with the disease in appropriate patients. Developed by Fujirebio Diagnostics, Inc., the test is now available nationwide through Labcorp.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the addition of Anterior Nasal Swab (ANS) as a validated specimen type for this panel, specifically for use with the respiratory test menu. By swabbing only the anterior part of the nasal cavity, ANS provides significantly more comfort for the patient.

Blood Coagulation Analyzer and Reagents 1. Overview of Domestic Blood Coagulation Market Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for blee..