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• Diagnostics
  

  Medivolve & Marvel Diagnostics Complete First Stage Clinical Testing of BlowFISH

  The technology has entered the next phase toward applying for an EUA from the FDA to test for the COVID-19 virus.

  Charles Sternberg, Assistant Editor 05.06.21
  

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• Testing
  

  The Evolution of Chemical Characterization for Medical Devices

  Evaluation of biological safety of devices is experiencing some of the most significant changes in history.

  Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21
  

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• Contract Manufacturing | Software & IT | Testing
  

  Quality & Regulatory Solutions for the FDA Regulated Industries

  EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.

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• Diagnostics
  

  BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

  BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.

  Sam Brusco, Associate Editor 04.01.21
  

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• Testing
  

  NAMSA Appoints New CEO, Board Chairman

  Dr. Christophe Berthoux will begin leading the company March 22; former AdvaMed Chairman Nadim Yared to become NAMSA Chairman.

  Sam Brusco, Associate Editor 03.15.21
  

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  CE Mark Granted to ProciseDx for Fecal Calprotectin Point-of-Care Testing

  Product will enable GI facilities in Europe to improve and accelerate patient care.

  Michael Barbella, Managing Editor 03.12.21
  

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• Testing
  

  Sotera Health Acquires BioScience Laboratories

  Strengthens Sotera Health’s antimicrobial and antiviral lab testing capabilities.

  Charles Sternberg, Assistant Editor 03.11.21
  

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• Deciding whether to insource or outsource your testing

  The medical device industry is filled with motivated medical entrepreneurs who have the next most significant concept to better human life.

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• Testing
  

  Stressed Testing: Challenges with Medical Device Testing

  The pandemic has resulted in unprecedented levels of demand for device testing with requests for rapid turnaround times.

  Mark Crawford, Contributing Writer 03.04.21
  

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• Electronics | Testing
  

  Refurbished Medical Equipment Testing and Certification Under the NEC

  The National Electric Code (NEC) has been updated to better ensure refurbished or reconditioned products' safety and performance.

  Online Exclusives L. Matthew Snyder, Director of Certification, Intertek 02.25.21
  

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  Canada Authorizes COVID-19 Diagnostic Assay That Boosts Virus Testing Efficiency

  The product is compatible with Thermo Fisher Scientific's Amplitude platform.

  Michael Barbella, Managing Editor 02.25.21
  

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  South Korean HIV Testing to Reach Peak Market Value This Year

  The sector's worth declined in 2020 due to COVID-19's impact in the country.

  Michael Barbella, Managing Editor 02.19.21
  

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• Diagnostics
  

  ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

  System can be used for COVID-19, Influenza A & B, and other viruses.

  Charles Sternberg, Assistant Editor 02.09.21
  

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• Testing
  

  Element Material Technology Acquires Avomeen

  Strengthens its life sciences business unit in North America.

  Charles Sternberg, Assistant Editor 02.03.21
  

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• 

  India's NIPT Testing Market Driven by Demand for Non-Invasive Genetic Assessments

  Not surprisingly, the market lost value last year due to COVID-19.

  Michael Barbella, Managing Editor 01.29.21
  

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• Diagnostics
  

  PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing

  Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.

  Business Wire 01.14.21
  

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• Diagnostics
  

  FDA, EU Nods for POC Testing on Siemens Healthineers' epoc NXS Host Mobile Computer

  Provides critical test results at the point of care in less than a minute.

  Siemens Healthineers 12.15.20
  

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• Diagnostics
  

  FDA Authorizes First COVID-19 Home Self-Testing Kit

  Lucira Health test provides lab-quality results in 30 minutes or less from home.

  U.S. Food and Drug Administration 11.18.20
  

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• Diagnostics
  

  Smartphone-based Solutions Boost Infectious Disease POC Testing Market 70.2 Percent

  Study reveals that digital POC platforms will enable diagnostic testing beyond the clinic, transforming how assay results are gathered and analyzed.

  Frost & Sullivan 11.10.20
  

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• Diagnostics
  

  How COVID-19 is Reshaping the Diagnostics Testing Sector

  The short-term impact on the diagnostics sector is readily apparent as the pandemic has fueled overwhelming demand for effective SARS-CoV-2 testing solutions.

  Eric Williams, Managing Director, Capstone Headwaters 11.04.20
  

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• 

  Ocutrx Vision Technologies Awarded Two Patents for Visual Field Testing, Dynamic Opacity Innovation

  One of the patents covers the company’s visual field perimetry testing technology.

  Ocutrx Vision Technologies LLC 11.02.20
  

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• 

  Antigen Testing is Crucial in Fight Against COVID-19 in India

  Antigen testing can be easily done on the spot in doctor’s clinics, day care centers, hospitals, home care settings, and industries.

  GlobalData 10.23.20
  

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• Diagnostics | Testing
  

  GenMark Diagnostics’ ePlex RP2 Receives EUA from FDA

  Provides results for more than 20 viruses and bacteria in less than two hours.

  GenMark Diagnostics Inc. 10.09.20
  

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• Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing

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• Diagnostics
  

  Hologic Granted EUA for Asymptomatic COVID-19 Testing

  Testing of pooled samples also authorized; new claims expected to help limit spread of COVID-19, open economy and schools.

  Business Wire 09.28.20
  

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• Testing
  

  Nelipak Facility Earns ISO/IEC 17025 Accreditation

  Provides a comprehensive range of testing services to support package testing requirements.

  Nelipak 09.10.20
  

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• Testing
  

  Assessing Nanoparticles for Biocompatibility

  It is important to have an appropriate testing protocol in place for this relatively new medical technology.

  Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Laboratories 09.01.20
  

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• Diagnostics
  

  A Breath of Fresh Air for COVID-19 Testing

  One of the latest COVID-19 testing innovations has recently emerged from Israel’s Technion-Israel Institute of Technology—a coronavirus breath test.

  Sam Brusco, Associate Editor 09.01.20
  

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• Qosina’s Swab Inventory Ranges in Application from COVID-19 Testing to Cleaning and Polishing

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• Chronic Disease | Diagnostics
  

  Diagnostic May Bring Faster, Cheaper Cancer Testing to Remote Settings

  The CytoPAN is used to study breast cells gathered with fine-needle aspiration, a less invasive alternative to standard biopsies.

  American Association for the Advancement of Science 08.07.20
  

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• Diagnostics
  

  Fujirebio Diagnostics Initiates Testing of Fully Automated COVID Antigen Assay

  The Lumipulse SARS-CoV-2 Antigen assay will be available for use on the LUMIPULSE G1200 instrument.

  Business Wire 08.05.20
  

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• Diagnostics
  

  FDA Authorizes New Quest Lab Technique to Boost COVID-19 Testing Capacity

  Speeds the process of extracting viral RNA from specimens.

  PR Newswire 07.31.20
  

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• Diagnostics
  

  AdvaMed Creates National COVID-19 Testing Registry

  Since the beginning of the pandemic, over 65 million tests have been manufactured and shipped nationwide, says AdvaMed.

  AdvaMed 07.29.20
  

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• Diagnostics
  

  Color Earns EUA for Unmonitored COVID-19 Testing

  Alleviates demand on healthcare workers from having to administer test samples.

  PR Newswire 07.28.20
  

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• Diagnostics
  

  Rapid PCR COVID Testing Trialed in London Care Homes

  Queen Mary University of London is leading a clinical trial of a new rapid COVID-19 testing system that delivers results in under an hour.

  Queen Mary University of London 07.23.20
  

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• 

  COVID-19 Testing Provider Curative Acquires KorvaLabs

  Accurate and rapidly scalable oral fluid test will continue to be produced and processed in KorvaLabs’ California facilities.

  Globe Newswire 07.17.20
  

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• Diagnostics
  

  EKF, Tosoh Europe N.V. Distribution Agreement Expands HbA1c Testing

  Three-year agreement will expand the reach of EKF's Quo-Test HbA1c point-of-care (POC) analyzer in the Middle East and Africa.

  EKF Diagnostics 07.15.20
  

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• Diagnostics
  

  BD Helps U.S. Government Increase COVID-19 Testing Capacity

  Government commits to use of BD Veritor Plus System and 15-minute SARS-CoV-2 test kits.

  PRNewswire 07.15.20
  

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• Diagnostics | Testing
  

  Alliant Offers COVID-19 Antibody Test Kits

  Allows individuals to screen for both IgG and IgM strands of the coronavirus.

  Globe Newswire 07.06.20
  

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• Diagnostics
  

  Eurofins Launches 10-Minute POC COVID-19 Testing Devices

  The serology-based, finger-prick tests detect virus antibodies with a sensitivity of 94.5 percent.

  Business Wire 07.01.20
  

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• 

  Medable, AliveCor Partner on In-Home ECG Testing

  Union marks an important step in the growth of decentralized clinical trials.

  Business Wire 06.30.20
  

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• Diagnostics
  

  Mass Home Testing for COVID-19 Is Not Without Risks

  GlobalData analyst claims there is no surefire, foolproof option for diagnosing the virus.

  GlobalData 06.23.20
  

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• Diagnostics | Testing
  

  Neoteryx's Mitra Device Registered with Australian TGA

  Can now be imported into Australia for use in research and clinical diagnostic applications.

  PRNewswire 06.22.20
  

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• Diagnostics
  

  Accelerated COVID-19 Testing Slowly Becoming Reality With NGS Technology

  COVIDSeq Test has the potential to be widely used, it has yet to officially gain FDA approval.

  GlobalData 06.22.20
  

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• Diagnostics
  

  BioLab Sciences Responds to Need for Rapid COVID-19 Testing

  Distributes millions of Rapid COVID-19 Result Tests to detect antibodies.

  BioLab Sciences 06.19.20
  

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• Diagnostics
  

  Fulgent Genetics' At-Home COVID-19 Testing Services Gains EUA

  Test detects nucleic acid from SARS-CoV-2.

  GlobeNewswire 06.17.20
  

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  Danish Robots Assisting Laboratory Technicians With Covid-19 Testing

  The robots are accelerating test analyses.

  Life Science Newswire 06.16.20
  

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  How Are MPO’s Top 30 Addressing COVID-19?

  J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

  Online Exclusives Sam Brusco, Associate Editor 06.09.20
  

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• Testing
  

  Going Beyond the Regulations to Evaluate Relevant Medical Device Risk

  Companies need to review their testing plan so it supports a successful submission, saves time, and ensures the long-term success of their product.

  Sherry Parker, Ph.D., Senior Director of Regulatory Toxicology, WuXi AppTec Medical Device Testing 06.04.20
  

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• Diagnostics
  

  Quest Diagnostics Launches COVID-19 Workforce Testing Services

  COVID-19 molecular diagnostic and serology antibody testing at core of new suite of services.

  PR Newswire 05.28.20
  

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