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  Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection

  The new detection method can help determine whether patients have had COVID-19 and if they might still have immunity to the disease.

  Michael Barbella 01.22.21
  

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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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  OraSure’s OMNIgene·ORAL Device Included in COVID-19 EUA Amendment

  Amendment will allow 3B BlackBio Biotech’s North American distributor to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S.

  OraSure Technologies Inc. 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
  

  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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  Rapid Screening App Uses Wearable Sensor Data to Detect COVID-19 Infection

  New screening tool proves almost twice as effective as temperature checks in predicting coronavirus.

  NeuTigers 01.13.21
  

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  Researchers Receive Funding to Develop Smart Vaccine Device

  New smart patch will deliver the COVID-19 vaccine and measure its efficacy through monitoring the body's associated response.

  Swansea University 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
  

  SARS-CoV-2 Mutation Prompts FDA Alert

  Impact remains low, but false negative results can occur with any molecular test.

  U.S. Food and Drug Administration 01.11.21
  

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• Diagnostics
  

  Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA

  Helps identify severe inflammatory immune responses in patients confirmed to have COVID-19.

  Siemens Healthineers 01.08.21
  

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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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• 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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• Diagnostics
  

  Decision Diagnostics CEO Charged in COVID-19 Fraud Scheme

  Falsely claimed the company developed a 15-second test to detect COVID-19 in a finger prick sample of blood.

  United States Department of Justice 01.04.21
  

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  Face Mask Filters 98 Percent of COVID-19 Particles

  Patented process sets new standard in pandemic PPE protection, surpassing N95 masks in efficacy.

  Medicevo Corporation 01.04.21
  

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  Modulim Granted CE Mark for Clarifi Imaging System for Microvascular Assessment

  Clarifi is the newest advancement for assessing tissue and microvascular function.

  Business Wire 01.04.21
  

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• Diagnostics
  

  FDA Authorizes Abbott's Rapid, $25 COVID-19 Test for At-Home Use

  Telehealth service will take users step-by-step through the sample collection process.

  U.S. Food and Drug Administration 12.17.20
  

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  CorVent, Siemens Healthineers Ink RESPOND-19 Ventilator Distribution Deal

  U.S. agreement expands Siemens Healthineers respiratory care portfolio to include critical care ventilators.

  PR Newswire 12.16.20
  

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• Diagnostics
  

  Abbott's COVID-19 IgG Quantitative Antibody Test Wins EU Approval

  Identifies levels of IgG antibodies that attach to the virus' spike protein.

  Abbott Laboratories 12.16.20
  

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• Patient Monitoring
  

  'Smart Ring' Could Spot a Fever Before You Feel It

  Advance could pave the way for early warning system on COVID-19 and flu using wearables.

  University of California - San Diego 12.14.20
  

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• Cardiovascular
  

  Innovative Health Obtains Patent for Microlumen Reprocessing Technology

  Paves the way for future innovation in the field by the company.

  Innovative Health Inc. 12.11.20
  

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  Anti-COVID-19 Nasal Spray is ‘Ready for Use in Humans’

  The spray was developed using compounds already approved by regulatory bodies in the United Kingdom, Europe, and the United States.

  University of Birmingham Enterprise 12.10.20
  

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• Diagnostics
  

  FDA Authorizes First Direct-to-Consumer COVID-19 Test

  LabCorp's Pixel test authorized for at-home sample collection with laboratory test processing.

  U.S. Food and Drug Administration 12.10.20
  

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  FDA Authorizes CorVent's RESPOND-19 Ventilator for Multiple Patient Use

  Provides reliable and affordable deployment to treat more patients during surges in clinical demand.

  PR Newswire 12.09.20
  

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• Diagnostics
  

  Combo COVID-19, Flu Home Test Gains EUA

  FDA authorizes first COVID-19 and flu combination test for use with home-collected samples.

  U.S. Food and Drug Administration 12.08.20
  

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• Molding
  

  A 'Trial and Error' Approach to Micromolded Parts

  The medical industry's stringent requirements makes innovation difficult for injection-molded components.

  Online Exclusives Michael Barbella, Managing Editor 12.07.20
  

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• Diagnostics
  

  CRISPR-Based COVID-19 Test Uses Smartphone Camera

  The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.

  PR Newswire 12.07.20
  

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• Molding
  

  Tooling Precision is Key to Micromolding Success

  Tool quality dictates part quality for all sizes of medical components.

  Online Exclusives Michael Barbella, Managing Editor 12.03.20
  

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• Diagnostics
  

  Roche's Elecsys Anti-SARS-CoV-2 S Antibody Test Earns EUA

  Detects antibodies against the SARS-CoV-2 spike protein.

  GlobeNewswire 12.02.20
  

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  RSNA News: Royal Philips Introduces Patient Management System

  Offers personalized care to patients during the COVID-19 pandemic.

  Royal Philips 11.30.20
  

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• Diagnostics
  

  RSNA News: RADLogics’ AI-Powered COVID-19 Medical Imaging Solutions

  The company’s latest algorithm enhancements to help radiologists distinguish between coronavirus and other abnormalities.

  RADLogics 11.30.20
  

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• Molding
  

  Smaller Cavity Features Not Always Sensible for Micromolded Products

  Though the need to reduce size is crucial, small cavity characteristics may be challenging to reproduce in volume.

  Online Exclusives Michael Barbella, Managing Editor 11.24.20
  

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• Software & IT
  

  GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement

  A necessary and important step when ventilating critically ill COVID-19 patients.

  Business Wire 11.23.20
  

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• 

  Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market

  Market was down nearly 60 percent in Q2 as COVID-19 forced the cancellation or postponement of elective procedures.

  GlobalData 11.19.20
  

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• 

  Pandemic Could Help Indonesia Strengthen Medical Device Sector

  The country aims to produce 70 percent of its medical supplies domestically as it realizes the need for being self-reliant.

  GlobalData 11.19.20
  

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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
  

  QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test

  Can accurately analyze over 30 samples per hour.

  Business Wire 11.12.20
  

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  University Develops AI Algorithm to Analyze Chest X-Rays for COVID-19

  Academic team created algorithm using 100,000 X-rays of patients who did not have COVID-19 and 18,000 X-rays of patients who did.

  Globe Newswire 11.10.20
  

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• Diagnostics
  

  GenScript's SARS-CoV-2 Neutralizing Antibody Detection Kit Wins EUA

  Only EUA authorized virus-free testing assay that detects neutralizing antibodies within an hour.

  PR Newswire 11.09.20
  

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  physIQ, Purdue University Studying Feasibility of COVID-19 Detection Through Smartwatch Data

  Data from the study will inform new algorithms to be developed by physIQ, a Purdue-affiliated digital health technology company.

  Business Wire 11.09.20
  

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  Company Develops COVID-19 Breathalyzer

  The innovation incorporates technology from the company's flagship marijuana breathalyzer.

  Globe Newswire 11.06.20
  

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  PrimeStore MTM Viral Transport Media Evaluated for Coronavirus Inactivation

  The patented transport media can help to increase COVID-19 testing capacity.

  EKF Diagnostics 11.06.20
  

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• 

  The Lost Year: 2020 Year in Review

  Lessons learned from the global coronavirus pandemic.

  Michael Barbella, Managing Editor 11.04.20
  

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  Fixing Face Mask Form and Function

  Masks for the general public are varied in both style and effectiveness.

  Sam Brusco, Associate Editor 11.04.20
  

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  Virtually the Same? The Challenges of Online Conferences

  Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.

  Dawn A. Lissy, Founder & President, Empirical 11.04.20
  

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• Digital Health
  

  Digital Health Delivers During a Year for the Ages

  Internet of Medical Things technologies have emerged as the key enabler of a much more holistic and complete disease-state management toolbox.

  Brad Womble, Senior Director of Strategy, Marketing, and Mergers & Acquisitions, Jabil Healthcare 11.04.20
  

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  Company Developing a COVID-19 Severity Risk Test for U.S. Government

  The technology, known as host-response diagnostics, rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm.

  Inflammatix 11.04.20
  

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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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