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• Diagnostics
  

  FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

  May be related to current mixing parameters of the PCR reaction mixture.

  U.S. Food and Drug Administration 09.20.21
  

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  Glaukos and Ivantis Settle Glaucoma Microstent Patent Suit

  Ivantis to pay $60 million and ongoing double-digit royalty to Glaukos.

  Business Wire 09.15.21
  

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  Thermo Fisher Scientific Launches Updated COVID-19 Test

  Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations.

  PR Newswire 09.10.21
  

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  Roche's COVID-19 Molecular Test Granted EUA

  First test authorized for use in screening, testing asymptomatic and symptomatic individuals with results within 20 minutes.

  PR Newswire 09.02.21
  

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  COVID-19 Accelerated Demand for Handheld Ultrasound Devices in China

  Market for these products is expected to grow 5 percent through 2025.

  GlobalData 09.01.21
  

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• Cardiovascular
  

  Stereotaxis and Microport EP Announce Broad Collaboration

  Aim to advance technology innovation and commercial adoption of robotics in electrophysiology in China.

  Stereotaxis Inc. 09.01.21
  

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  Safeguard DNA Diagnostics Launches Dry Collection Swabs for COVID-19 Testing

  The dry swabs are being rolled out in Philippine laboratories.

  Business Wire 08.24.21
  

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  Glaukos' PRESERFLO MicroShunt Approved in Australia

  Product is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma.

  Business Wire 08.19.21
  

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  FDA Grants Three Emergency Use Authorizations for COVID-19 Rapid Antigen Tests

  OraSure Technologies' tests are authorized for over-the-counter use without a prescription, as well as for prescription and professional use in POC settings.

  Globe Newswire 08.18.21
  

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  Health Canada Approves Quidel’s Sofia SARS Antigen FIA Test

  Assay is used for serial testing to detect active coronavirus infection in both symptomatic and asymptomatic populations.

  Business Wire 07.30.21
  

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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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  Avanos Medical Fined $22M for MicroCool Surgical Gown Misbranding

  Gowns were falsely labeled as providing the highest level of protection against fluid and virus penetration.

  U.S. Department of Justice 07.12.21
  

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• 

  Santen Granted Health Canada Approval of PRESERFLO MicroShunt

  The product is currently available in Europe.

  Business Wire 07.07.21
  

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• Contract Manufacturing
  

  Receiving FDA Approval in Under One Month

  How the team working on an “Open-Source” COVID Ambu-bot Ventilator optimized its short timeline.

  Online Exclusives Aaron Burlew, Senior Applications Engineer, Teknic Inc. 07.06.21
  

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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
  

  Face Mask Prototype Can Spot COVID-19 Infection

  Sensor tech could also create clothing that detects a variety of pathogens and other threats.

  Anne Trafton, MIT News Office 06.30.21
  

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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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• 

  COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028

  Most lucrative growth to occur in Asia Pacific region.

  Polaris Market Research 06.28.21
  

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  Improved COVID-19 Survival Rates Shown With Seraph 100 Blood Filter

  Agnostic treatment for septic shock targets SARS-CoV-2 pathogen directly.

  Business Wire 06.24.21
  

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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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  enlightenVue Expands Patent Claims for its Single-Use Micro-Endoscope Platform

  The technology enables for the first time direct visualization of blood vessels along with simultaneous endovascular therapeutic intervention.

  Business Wire 06.18.21
  

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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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• Molding
  

  MTD Micro Molding Marks Facility Expansion Opening

  Ceremony included unveiling of plaque to honor late president.

  Sean Fenske, Editor-in-Chief 06.07.21
  

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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 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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  FDA Policy Supports the Use of Dry Heat Systems in the Processing of N95 Masks

  Allows Tenney Environmental to supply equipment in the fight against COVID-19.

  Charles Sternberg, Assistant Editor 05.06.21
  

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• Diagnostics
  

  COVID Diagnostics from Beckman Coulter—A Medtech Matters Podcast

  MPO's Sean Fenske speaks with Chris Hagen of Beckman Coulter about the company’s response to the need for COVID diagnostics and the rapid ramp-up of production.

  Sean Fenske, Editor-in-Chief 05.04.21
  

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• Surgical
  

  FDA Clears XPERIENCE No Rinse Antimicrobial Solution

  The solution defends against germs for hours and can used in virtually every open surgery case.

  Michael Barbella, Managing Editor 05.04.21
  

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  Respiratory Equipment's Pandemic Spotlight

  Ventilator and critical component manufacturers supercharge production to meet COVID-19’s demand for respiratory aids.

  Sam Brusco, Associate Editor 05.03.21
  

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• Contract Manufacturing
  

  Medtech's 2021 Full Service Outsourcing Roundtable

  Outsourcing service providers share lessons learned and how they were able to tackle the COVID-19 challenges to fulfill the needs of their OEM customers.

  Sean Fenske, Editor-in-Chief 05.03.21
  

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  Ava Begins Evaluation of its Fertility Tracking Sensor Bracelet in COVID-19 Detection

  Pilot study data shows Ava's algorithm accurately detected 71 percent of COVID-19 positive infections two days before symptom onset.

  Michael Barbella, Managing Editor 04.27.21
  

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• 

  Piezo Motion Debuts Piezoelectric Micro-Dosing Pump

  Applications that traditionally require two or three separate laboratory devices can now be replaced with a single micro-dosing pump.

  Michael Barbella, Managing Editor 04.20.21
  

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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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  MICRO Expands with New Facility in Costa Rica

  Increases its cleanroom assembly capacity to better serve its medical device customers.

  Charles Sternberg, Assistant Editor 04.13.21
  

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  BreathDirect’s BDR-19 Critical Care Ventilator Receives EUA From FDA

  The machine is built primarily for intensive care units and capable of a full continuum of respiratory support.

  Michael Barbella, Managing Editor 04.06.21
  

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  Thermo Fisher Scientific Launches Customizable TaqMan COVID-19 Mutation Panel

  Panel designed to provide surveillance of ongoing coronavirus mutations.

  Michael Barbella, Managing Editor 04.06.21
  

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• Diagnostics
  

  PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

  With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.

  Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21
  

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• 

  Global Supply Chain Wisdom from Coronavirus-Colored Lenses

  There are precious pearls of wisdom from this past year that will come in handy during the next “crisis.”

  Chris Oleksy, Founder and CEO, Oleksy Enterprises and Co-Founder Next Life Medical; CEO, Emergent Respiratory 04.01.21
  

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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
  

  Diagnosing the IVD Market: An Interview with TEAM Technologies

  Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.

  Online Exclusives Sam Brusco, Associate Editor 03.30.21
  

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• Cardiovascular
  

  Heart Failure Treatment Using Electrical Microcurrent Shows Promise

  Berlin Heals' C-MIC device restores endogenous electric potential gradients using microcurrents, leading to improved myocardial function.

  Michael Barbella, Managing Editor 03.30.21
  

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