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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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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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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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Diagnostics | Digital Health
Chip for Biomolecule Detection May Help in COVID-19 Testing
Purdue University's technique involves machine learning to train the system to detect certain features associated with particular diseases and viruses.Purdue University 05.22.20
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Diagnostics
FDA Lists Bio-Rad’s Real-Time PCR System for IVD Testing
The system may be used to help in the diagnosis of COVID-19.Bio-Rad Laboratories Inc. 05.19.20
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Diagnostics
Ortho Clinical Diagnostics, Quest to Broaden Availability of COVID-19 Antibody Testing
Quest will use Ortho’s IgG antibody test to test 3 million patients per month for coronavirus antibodies.Ortho Clinical Diagnostics 05.12.20
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Keeping Compliance on Track Through Testing
The beginning of 2020 has left the industry strained and delayed implementation of the Medical Device Regulation by one year.Sandi Schaible, WuXi Medical Device Testing 05.01.20
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Testing Lab to Pay Up to $43 Million for Unnecessary Test Billing
The settlement resolves allegations that Genova Diagnostics submitted false claims to Medicare, TRICARE, and the federal employee health program.U.S. Department of Justice 04.28.20
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Medtech’s Battle on Multiple Fronts Against COVID-19
From PPE to testing to ventilator solutions, medtech firms are trying to find answers for healthcare’s needs against the novel coronavirus.Online Exclusives Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20
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Diagnostics
BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test
Adds automated extraction methods and additional PCR systems.PR Newswire 04.27.20
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Study Finds UVC Technology Deactivates Human Coronavirus on Footwear
Shoes and floors identified as major source of coronavirus spread well beyond patient rooms in hospital settings.Business Wire 04.27.20
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FDA OKs ALung Hemolung Respiratory Assist System to Treat COVID-19
Hemolung can be a valuable tool to be used in conjunction with invasive mechanical ventilation.Business Wire 04.27.20
