Latest Headlines

  1. PhAST Corp. Receives FDA Clearance For Rapid Antimicrobial Susceptibility Testing Directly From Positive Blood Cultures 9/23/2026

    PhAST Corp., an in vitro diagnostics company building a single-cell computer vision platform for rapid phenotypic testing across clinical microbiology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the PhAST instrument and the PhAST Blood Culture Gram-negative Panel (PhAST BC GN Panel, K253316), granted June 2026.

  2. Werfen Announces US FDA 510(k) Clearance And CE Mark For Aptiva® Antiphospholipid Syndrome IgA Reagent 9/23/2026

    Werfen today announced that its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin A (IgA) Reagent has received both U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark under the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR).

  3. Bionano Laboratories Announces Expansion Of Diagnostic Testing Based On Optical Genome Mapping For Hematologic Malignancies 9/23/2026

    Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (Nasdaq: BNGO) that offers CLIA-certified laboratory developed test (LDTs), today announced expansion of optical genome mapping (OGM) based testing of hematologic malignancies at Memorial Sloan Kettering Cancer Center (MSK), following approval from the New York State Department of Health (NYSDOH).

  4. Mayo Clinic Laboratories Invests In Pathology Asia Holdings And LifeStrands Genomics To Advance Diagnostics And Precision Medicine 9/23/2026

    Mayo Clinic Laboratories and Pathology Asia Holdings (PAH) have announced a strategic investment and collaboration aimed at expanding access to advanced diagnostics and precision medicine across Southeast Asia, Australia and New Zealand.

  5. BioEdge Research Labs Announces Quality-Control Measures For Research Materials 9/22/2026

    BioEdge Research Labs, a United States-based supplier of research peptides and reference materials, today announced quality-control measures for its research product line. The measures strengthen the analytical checks and batch-level documentation applied to the company's research-use-only materials.

  6. RealTime Laboratories Launches 31-Marker Mycotoxin Extensive Panel, The Most Comprehensive Urinary Mycotoxin Test On The Market 9/22/2026

    RealTime Laboratories Inc., a US BioTek medical and diagnostic laboratory specializing in mold and environmental toxin detection, today announces the launch of its Mycotoxin Extensive Panel, the most comprehensive urinary mycotoxin test available on the market.

  7. UK Digital Pathology Provider Source BioScience Chooses Sectra To Enable Seamless Pathology Collaboration Across The NHS 9/21/2026

    International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has signed an agreement with Source BioScience UK Ltd (Source BioScience) in the UK to deliver its service for advanced share and collaborate workflows.

  8. Umbrella Labs Announces Documentation And Traceability Update For SLU-PP-332 Research Material 9/21/2026

    Umbrella Labs today announced an updated documentation and traceability framework for SLU-PP-332 research material supplied strictly for laboratory developmental research use only. 

  9. Precure, LLC Selects Helix As Multi-Omics Lab And AI Tools Provider 9/21/2026

    Precure, LLC today announced the selection of Helix as its multi-omic laboratory and AI tools provider supporting plans to generate comprehensive molecular data from approximately one million biospecimens and accelerate the integration of molecular insights into routine clinical care at Mayo Clinic and across health systems more broadly.

  10. Agilent Launches TapeStationDx Systems For Clinical NGS Sample Quality Control 9/21/2026

    Agilent Technologies Inc. today announced the launch of the Agilent 4150 TapeStationDx system, Agilent 4200 TapeStationDx system and Agilent TapeStationDx software, extending the company's automated electrophoresis portfolio into regulated clinical laboratory environments.