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• Diagnostics
  

  BurstIQ and FlowMetric Life Sciences Launch Novel Vaccine Immune Response Test

  The VaxEffect platform empowers both patients and providers to make more informed health decisions.

  07.23.21
  

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• Testing
  

  Guidance on Skin Irritation With a Push to Achieve the 3 Rs

  The publication of ISO 10993-23:2021 marks a paradigm shift in prioritizing in-vitro testing alternatives within the medical device biocompatibility space.

  Nick Hibbard, In-Vitro Scientific Research Fellow at WuXi AppTec Medical Device Testing 07.22.21
  

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  Supply Chain’s Latest Challenge: The Labor Shortage

  During my career configuring global supply chains, I never imagined a lack of available (or willing) workers would become one of the most formidable challenges.

  Chris Oleksy, Founder and CEO, Oleksy Enterprises and Co-Founder, Next Life Medical; CEO, Emergent Respiratory 07.22.21
  

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• Cardiovascular | Digital Health
  

  Studies Show AI-Driven Blood Test Accurately Predicts Heart Attack Risk

  Data indicate the test also can correctly portend stroke and cardiac death risk.

  Business Wire 07.21.21
  

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• Diagnostics
  

  Owlstone Medical Launches Breath Testing for Digestive Health

  Testing enables patients to take better control over their digestive health through a simple at-home breath test.

  Owlstone Medical 07.19.21
  

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  QIAGEN Granted EUA for Digital COVID-19 Antibody Test

  eHub digital device can handle eight tests at once, all working independently of each other, and can process up to 32 samples per hour.

  Business Wire 07.15.21
  

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• Diagnostics
  

  Hologic Gains CE Mark for Saliva Samples with COVID-19 Test

  Hologic has shipped over 100 million Aptima COVID-19 tests globally since spring 2020.

  Business Wire 07.14.21
  

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• Testing
  

  EAG Expands Medical Device Testing Services With New Lab

  The laboratory includes a dedicated medical device polymer analysis area.

  Business Wire 07.12.21
  

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• Diagnostics
  

  Global POC Diagnostic, Testing Market to Top $34B by 2027

  The advent of advanced technologies, a growing geriatric population, and the rising prevalence of infectious as well as chronic diseases will help drive growth.

  Globe Newswire 07.01.21
  

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  Ultra-Fast COVID-19 Antibody Test Under Development

  Test could be used worldwide to help prioritize who should receive coronavirus vaccines.

  Business Wire 07.01.21
  

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• Diagnostics
  

  How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

  Leveraging technology to improve speed to market without sacrificing quality.

  Online Exclusives Brandon Henning, VP of Product at Greenlight Guru 07.01.21
  

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• Diagnostics
  

  PixCell's Rapid Blood Test Diagnostics

  MPO's Sean Fenske speaks with Hanan Ben-Asher of PixCell Medical about the opportunities enabled with rapid blood diagnostics.

  Sean Fenske, Editor-in-Chief 06.29.21
  

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  TÜV SÜD North America Gains FDA Accreditation for Device Testing

  TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five U.S. locations and in Canada.

  Business Wire 06.29.21
  

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• Diagnostics
  

  Abbott's Panbio Rapid COVID-19 Antigen Self-Test Earns EU Approval

  Approved for sale directly to consumers and for use in adults and children with or without symptoms.

  Abbott Laboratories 06.28.21
  

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  Minute Molecular Wins Contract to Expedite Manufacturing of Rapid COVID-19 Test

  Assay allows highly sensitive PCR testing to take place at the point-of-care, and outside the traditional laboratory environment.

  Business Wire 06.22.21
  

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  QIAGEN Launches Technology to Triple COVID-19 Lab Testing Capacity

  The innovation integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift.

  Business Wire 06.15.21
  

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  Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing

  he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.

  Michael Barbella, Managing Editor 06.04.21
  

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• Cardiovascular | Patient Monitoring
  

  AliveCor Buys CardioLabs, an Independent Dx Testing Firm

  Sets stage for launch of advanced ambulatory monitoring services.

  Sam Brusco, Associate Editor 06.03.21
  

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• Diagnostics
  

  A One-Second Saliva-Based COVID Test

  Researchers have built a microfluidic device capable of detecting the SARS-CoV-2 spike protein in a saliva sample within an astonishing one second.

  Sam Brusco, Associate Editor 06.02.21
  

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• Most Trusted Medical Device Testing Partner 2019 – Midwest USA

  Element is a global provider of testing, inspection and certification services for the materials, products and systems

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• Element ASTM accreditation for face mask testing helps meet extraordinary demand

  In the US and Europe

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  Minnetonka, Minnesota Cardiovascular Testing

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• Your Most Trusted R&D Testing Partner

  Bringing innovative medical device technology to the marketplace is a high risk venture.

  Infographics

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• Most Common Microbiology Testing Methods

  For Medical Devices and Pharmaceutical Products

  Infographics

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  BrainChip, Biotome Partner on COVID-19 Antibody Test

  The goal is to produce a handheld device that can provide accurate results in seconds.

  Michael Barbella, Managing Editor 05.19.21
  

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  Quidel Granted EUA to Market COVID-19 Antigen Test

  Assay provides results in 15 minutes and s now available without a prescription.

  Michael Barbella, Managing Editor 05.17.21
  

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  EUROIMMUN Launches Test to Determine Neutralizing Capacity of Anti-COVID-19 Antibodies

  The technology expands EUROIMMUN’s offerings for labs that seek to understand immune response to the coronavirus.

  Michael Barbella, Managing Editor 05.13.21
  

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  FDA Grants Emergency Authorization to Quidel’s At-Home COVID-19 Test

  Easy-to-use assay provides results in 10 minutes.

  Michael Barbella, Managing Editor 05.13.21
  

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  FDA Grants EUA to Beckman Coulter's COVID-19 Antibody Test

  Assay being rolled out in laboratories throughout the New York City metropolitan area.

  Michael Barbella, Managing Editor 05.11.21
  

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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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  QIAGEN Granted EUA for its 4-Plex COVID-19 Test

  The assay can detect and differentiate influenzas A and B, respiratory syncytial virus (RSV), and COVID-19 infections within 80 minutes.

  Michael Barbella, Managing Editor 05.06.21
  

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• Diagnostics
  

  CerTest Biotec & BD Add Saliva to the Visasure SARS-CoV-2 Detection Kit

  Allows BD MAX System users more flexibility with three alternatives for specimen collection.

  Charles Sternberg, Assistant Editor 04.27.21
  

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• Diagnostics
  

  Abbott Begins Shipping Rapid COVID Self-Tests

  Abbott to manufacture tens of millions of BinaxNOW Self Tests per month.

  Sam Brusco, Associate Editor 04.20.21
  

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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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• 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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• Element - Your Most Trusted R&D Testing Partner

  Element strives to provide absolute testing certainty with Class I, II, and III medical devices.

  Infographics

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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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