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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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Diagnostics
Abbott's Rapid COVID-19 Self-Test Receives EUA
Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.Sam Brusco, Associate Editor 04.01.21
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Diagnostics
BD's Combo COVID-19, Flu Rapid Antigen Test Earns EUA
Can detect SARS-CoV-2, influenza A, influenza B from a single patient sample in 15 minutes.Sam Brusco, Associate Editor 03.30.21
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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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Automated DNA extraction: 40,000 genetic tests per day
Dutch company Synchron Lab Automation has made a breakthrough in the extraction of plant DNA.
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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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Diagnostics
FDA Issues EUA to First OTC Home Molecular COVID-19 Test
Results from the Cue COVID-19 test are sent directly to a companion app in about 20 minutes.Sam Brusco, Associate Editor 03.08.21
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Diagnostics
Avacta’s Rapid Antigen Test Proves Effective for New Coronavirus Variants
Detects the B117, or ‘Kent’, variant, and the D614G variant, as well as the original strain.Charles Sternberg, Assistant Editor 03.08.21
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How do I create a test protocol
When planning any testing project, it is critical you develop a test protocol.
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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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Requirements and Impact of the New Guideline- ISO 10993-23: Tests for Irritation
Join us for an intense and informative discussion on this standard and learn what steps to take to incorporate this testing into your biocompatibility program.03.04.21
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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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Diagnostics
Quidel's QuickVue At-Home COVID-19 Test Earns EUA
Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription.Sam Brusco, Associate Editor 03.02.21
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New COVID-19 Saliva Test Also Can Detect Variants and Flu Viruses
Emergency Use Authorization application filed with the FDA.Michael Barbella, Managing Editor 03.01.21
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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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Previon, Spectrum Solutions Partner to Deliver At-Home COVID-19 Test
The pair will create and deliver COVID-19 PCR test kits to essential workers and at-risk populations.Michael Barbella, Managing Editor 02.24.21
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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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Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production
New plant aims to reach a run rate of 600 million QuickVue tests per year by the end of 2021.Michael Barbella, Managing Editor 02.18.21
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Diagnostics
Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation
The assay is currently available in Europe.Michael Barbella, Managing Editor 02.16.21
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Diagnostics
FDA Authorizes Luminostics' 30-Minute Smartphone-Based COVID-19 Test
Luminostics is ramping up production with a target capacity of four million+ tests per month by summer.Videos Sam Brusco, Associate Editor
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Diagnostics
BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test
Also shows ability to detect U.K., South African variants of COVID-19.Sam Brusco, Associate Editor 02.12.21
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HORIBA Acquires MedTest Dx and Pointe Scientific
Deal will expand HORIBA's laboratory chemistry offerings.Michael Barbella, Managing Editor 02.11.21
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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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China's COVID-19 PCR Test Market to be Worth $2 Billion Next Year
The market will be driven by the country’s mass testing strategy and PCR testing requirements for travelling.Michael Barbella, Managing Editor 02.08.21
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Machining & Laser Processing
Addition by Subtraction: The Latest of Machining for Medtech
As machining gets “smarter” and more precise with laser-based capabilities, it continues to offer value to medtech manufacturers.Mark Crawford, Contributing Writer 02.03.21
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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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Solid Growth Forecast for India's HER2 Amplification Tests Market
Sector is expected to expand 7 percent annually over the next five years.Michael Barbella, Managing Editor 01.26.21
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Diagnostics
Abbott's Panbio Rapid COVID-19 Antigen Test Earns CE Mark for Two New Uses
EU approves symptomatic screening and self-administered sample collection with nasal swab.Sam Brusco, Associate Editor 01.26.21
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At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
Public health officials need to stress the importance of mass testing and contact tracing even with several vaccines approved.Michael Barbella, Managing Editor 01.25.21
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FDA Grants Emergency Use Authorization for COVID-19 Rapid Antibody Fingerstick Test
The serology test can be used in point-of-care settings, delivering results in 15-20 minutes.Business Wire 01.21.21
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Cardiovascular
FineHeart Successfully Tests Wireless TET System
A breakthrough in treating patients with severe heart failure.FineHeart 01.18.21
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Beckman Coulter Launches High-Throughput COVID-19 Antigen Test in U.S.
Test runs on company’s analyzers are capable of processing up to 200 samples per hour, enabling high throughput screening in 30 minutes.Beckman Coulter 01.14.21
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Diagnostics
Rapid Antigen Tests Manufacturer Acquires BIOLAB
Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.Innova Medical Group Inc. 01.14.21
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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
High-Volume COVID Antigen Test Receives FDA EUA
Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.Ortho Clinical Diagnostics 01.13.21
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Diagnostics
Abbott to Supply Additional 30M COVID-19 Tests to U.S. Gov't
Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites.PR Newswire 01.13.21
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CarThera Starts New Clinical Trial to Test its SonoCloud-9 Device
Study will determine the safe dose of Abraxane to be used with SonoCloud-9 in recurrent glioblastoma patients.CarThera 01.12.21
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Diagnostics
ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test
Provides fast, accurate, and easy-to-interpret test results.PRNewswire 01.11.21
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Diagnostics | Neurological
FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test
Produces a result within 15 minutes after a plasma sample is inserted.Abbott Laboratories 01.11.21
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Diagnostics
University of Birmingham Researchers Invent New COVID-19 Test
Delivers accurate results within minutes.University of Birmingham 01.07.21
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Chronic Disease | Diagnostics
Hologic to Buy Cancer Test Maker Biotheranostics for $230M
Accelerates Hologic’s entry into the oncology growth market, provides new lab capabilities.Business Wire 01.06.21
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Thyroid Function Tests Market in India to Reach $125 Million in 2025
Thyroid stimulation hormone tests are expected to account for more than 75 percent of the market.GlobalData 01.06.21
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Diagnostics
EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit
The test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies.EKF Diagnostics 01.05.21
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Diagnostics
Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval
Preliminary results show 92% sensitivity and 100% specificity, compared with RT-PCR.Mologic Ltd 01.05.21
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