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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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• 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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• 

  Axonics Forges Manufacturing Partnership With Micro Systems Technologies

  Companies will produce the newly-developed Axonics non-rechargeable implantable neurostimulator.

  Michael Barbella, Managing Editor 03.24.21
  

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• Diagnostics
  

  FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device

  Identifies biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions.

  Sam Brusco, Associate Editor 03.23.21
  

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• Chronic Disease
  

  FDA Approves Boston Scientific's TheraSphere Y-90 Glass Microspheres

  The only radioembolization treatment approved for U.S. patients with hepatocellular carcinoma.

  Sam Brusco, Associate Editor 03.18.21
  

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• 

  Detecting COVID-19 With a Skin Sticker

  University of Missouri engineer receives grant to plan for large-scale manufacturing of an on-skin, wearable bioelectronic device.

  Michael Barbella, Managing Editor 03.17.21
  

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• Diagnostics
  

  Roche to Acquire GenMark Diagnostics for $1.8B

  GenMark’s syndromic panel testing portfolio complements Roche’s current molecular diagnostics portfolio.

  Sam Brusco, Associate Editor 03.15.21
  

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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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• Diagnostics
  

  EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

  One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B.

  Michael Barbella, Managing Editor 03.05.21
  

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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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• 

  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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• 

  Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.

  Provides respiratory support for patients with COVID-19 and other respiratory conditions.

  Sam Brusco, Associate Editor 02.23.21
  

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• Diagnostics
  

  Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

  Real-time electronic system will be able to detect minute amounts of SARS-CoV-2.

  Charles Sternberg, Assistant Editor 02.22.21
  

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• Diagnostics
  

  BD Collaborates with Scanwell Health

  Aims to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.

  Charles Sternberg, Assistant Editor 02.22.21
  

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• 

  Jabil Protective Face Masks Cleared by FDA

  Memphis facility is fulfilling high-volume orders for single-use masks that meet federal requirements.

  Charles Sternberg, Assistant Editor 02.19.21
  

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• Diagnostics
  

  Study Validates Vocalis Health’s COVID-19 Screening Tool

  VocalisCheck obtains CE mark approval for medical use.

  Charles Sternberg, Assistant Editor 02.18.21
  

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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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• Digital Health | Patient Monitoring
  

  Masimo Launches Tool to Support Reopening Schools, Businesses

  Masimo SafetyNet-OPEN helps screen, trace, and manage users as they face COVID-19 and other infectious illnesses.

  Sam Brusco, Associate 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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