Latest Headlines

  1. BD Introduces Smart Connected Robotics To Automate Microbial Identification 1/7/2022

    BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Kiestra™ IdentifA system, which is designed to automate the preparation of microbiology bacterial identification testing.

  2. Pillar Biosciences Receives CLIA Certification For Its Next-Generation Sequencing Clinical Laboratory 1/6/2022

    Pillar Biosciences, an innovative, next-generation sequencing (NGS) solutions, in-vitro diagnostics (IVD) company, today announced that its NGS laboratory, located in Natick, Massachusetts, has passed the onsite inspection and received Clinical Laboratory Improvement Amendment (CLIA) certification from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS), as well as the Massachusetts state permit.

  3. DevLab Bio Awarded CAP Accreditation 1/6/2022

    DevLab, LLC is proud to announce that the College of American Pathologists (CAP) has awarded accreditation to DevLab, LLC, dba DevLab bio, by the Accreditation Committee due to results of an on-site inspection performed by the CAP Accreditation Program.

  4. Phase Genomics Advances Precision Oncology With OncoTerra A New Ultra-Long-Range Sequencing Powered Platform 1/5/2022

    Phase Genomics, Inc., a biotech company leading advancements in next-generation sequencing (NGS) solutions for genome assembly and analysis, today announced the launch of its new platform for precision oncology.

  5. Colibri™ Automated Specimen Workup Instrument By COPAN Receives FDA 510(k) Clearance For Use With MALDI-TOF Mass Spectrometry Analyzers 1/5/2022

    COPAN Diagnostics is proud to announce the FDA clearance of Colibri™, an automated processor that is a complementary part of WASPLab®, COPAN's full laboratory automation system.

  6. Applied DNA Receives New York State Department Of Health Conditional Approval For Linea 2.0 COVID-19 Assay As Laboratory Developed Test 1/4/2022

    Applied DNA Sciences, Inc. (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL), has received conditional approval from the New York State Department of Health (NYSDOH) for its Linea 2.0 Assay (the “Linea 2.0 Assay”) as a Laboratory Developed Test (LDT), pending a final review of the assay’s validation data by NYSDOH.

  7. Werfen Receives US FDA 510(K) Clearance For GEM® Hemochron™ 100 Whole Blood Hemostasis Testing System 1/4/2022

    Werfen today announced the 510(k) clearance of the GEM Hemochron 100 whole blood hemostasis system by the US Food and Drug Administration (FDA). Leveraging leading Hemochron technology, the GEM Hemochron 100 system, delivers fast, actionable activated clotting time (ACT) results in minutes, informing patient-management decisions and helping improve workflow at the point of care (POC).

  8. Rapid Rack Readers Help Lab Lower Cost Of COVID-19 PCR Testing 1/4/2022

    Ziath reports how its super-fast 2D barcode rack readers are assisting leading COVID-19 testing lab – SummerBio LLC (Menlo Park, California, USA) to offer rapid, low-cost, high-volume testing solutions for educational organizations, employers and laboratories.

  9. Gestalt Diagnostics And MindPeak Provide The First Artificial Intelligence Based Diagnostics Solution Used In Clinical Routine Pathology In The USA 1/4/2022

    Hamburg, Germany, based Mindpeak and Spokane, WA, based Gestalt Diagnostics have achieved a major success on their way to improve patient care with Digital Pathology and Artificial Intelligence (AI).

  10. CENTOGENE’s CentoCloud® Set To Revolutionize Rare Disease Diagnostics With Decentralized SaaS Platform For Laboratories Around The World 1/4/2022

    Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on generating data-driven insights to diagnose, understand, and treat rare diseases, today announced the global release of CentoCloud, a SaaS platform enabling decentralized analysis, interpretation, and reporting of genomic variants linked to rare diseases.