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..

Danaher Collaborates with Shanghai National Engineering Research Center for Biochip to Jointly Launch Asia's First Intelligent In Vitro Model System On August 8, the inaugural "AI-Empowere..

Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI Prostate, establishing it as the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer.

Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended June 30, 2025.

Caris Life Sciences, Inc.® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company, today reported financial results for the quarter ended June 30, 2025.

Syncell, Inc., a pioneer in subcellular spatial proteomics, announced a strategic co-marketing agreement with Thermo Fisher Scientific to bring a fully integrated, high-resolution spatial proteomics workflow to the market. The collaboration highlights the power of integrating Syncell’s proprietary Microscoop® technology for spatial protein purification with Thermo Fisher’s ultra-sensitive Orbitrap™ Astral™ mass spectrometer and newly released Orbitrap™ Astral™ Zoom mass spectrometer.

Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM) ("PAVmed"), today provided a business update for the Company and reported financial results for the three months ended June 30, 2025.

Original from: PR Newswire Research and development of new AI-powered tech is causing a major overhaul in the healthcare sector, with experts both optimistic and horrified at the same time. Analysts at ma..

GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the second quarter 2025.

To support countries in their efforts to strengthen detection of TB disease and infection, the World Health Organization (WHO) has published an updated version of the WHO operational handbook on tuberculosis: module 3:diagnosis,to accompany the WHO consolidated guidelines on tuberculosis published earlier this year. The document provides laboratory personnel, clinicians and other clinical staff, as well as ministries of health and technical partners, with detailed guidance on implementing WHO evidence-based recommendations. Furthermore, it describes operational considerations for the use of WHO-recommended tests, providing an overview of all testing classes, presenting revised model algorithms, and outlining the steps and processes required to implement and scale up new tests and testing strategies.

1.6 Substance Abuse Categories Point-of-Care drugs of abuse testing is estimated at $576 million and is anticipated to grow at 2.4% over the next five years. It is anticipated that drug testing technology will b..

Tellgen Acquires Wuhan HealthCare Biotechnology for CNY 328 Million Tellgen Life (300642.SZ) announced plans to acquire a total of 82% equity in Wuhan HealthCare Biotechnology Co., Ltd., further expanding..