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  Flexan Announces FDA Registration of Manufacturing Facility in China

  The Suzhou location is the company’s fourth FDA registered location.

  Flexan LLC 12.10.20
  

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  Real-World Data for Medtech Approval Reduces Time to Market in China

  The Chinese market is forecast to grow 5.6 percent over the next five years.

  GlobalData 08.05.20
  

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  How Are MPO’s Top 30 Addressing COVID-19?

  J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

  Online Exclusives Sam Brusco, Associate Editor 06.09.20
  

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• Diagnostics
  

  BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test

  Adds automated extraction methods and additional PCR systems.

  PR Newswire 04.27.20
  

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  Study Finds UVC Technology Deactivates Human Coronavirus on Footwear

  Shoes and floors identified as major source of coronavirus spread well beyond patient rooms in hospital settings.

  Business Wire 04.27.20
  

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  GlobalData: Medtronic’s MI Business to Exhibit Slow Growth

  Aliyah Farouk, Medical Device Analyst at GlobalData offers her view.

  GlobalData 04.24.20
  

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• Electronics | Patient Monitoring
  

  Sensors Woven into a Shirt Can Monitor Vital Signs

  Comfortable, form-fitting garments could be used to remotely track patients' health.

  Massachusetts Institute of Technology 04.24.20
  

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  FDA OKs Baxter's Oxiris Blood Purification Filter for COVID-19 Treatment

  Only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood.

  Baxter 04.24.20
  

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  Health Canada Expands Emergency Use of CeraShield Endotracheal Tube

  May help prevent deadly ventilator-associated bacterial infections and complications in COVID-19 patients.

  PR Newswire 04.24.20
  

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  The Medtech Supply Chain and COVID-19

  How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?

  Online Exclusives Sean Fenske, Editor-in-Chief 04.22.20
  

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  Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

  The company says it is well positioned for recovery.

  Globe Newswire 04.22.20
  

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• Diagnostics
  

  FDA OKs Seegene's Allplex 2019-nCoV Assay

  Seegene's technology has played a pivotal role in South Korea's rapid response to the COVID 19 outbreak.

  PR Newswire 04.22.20
  

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• Diagnostics
  

  GenoSensor's High-Throughput COVID-19 RT-PCR Diagnostic Granted FDA EUA

  Provides test results in less than 90 minutes.

  Business Wire 04.21.20
  

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• Diagnostics
  

  FDA OKs Fosun Pharma's COVID-19 RT-PCR Detection Kit

  Can complete detection of 96 samples within two hours.

  PR Newswire 04.20.20
  

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• Contract Manufacturing
  

  Philips Partners with Flex, Jabil to Speed Hospital Ventilator Production

  Philips hopes to manufacture 4,000 units per week by the third quarter.

  Philips 04.14.20
  

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  FDA Clears EndoClot Plus's GI Submucosal Lifting Product

  Product targets the rapidly growing U.S. endoscopic submucosal dissection market.

  Business Wire 04.14.20
  

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  Domestic Manufacturing of Medical Devices Trending Due to COVID-19

  Ramping up domestic production capacity of medical supplies is the major focus for many countries as the pandemic spreads, according to GlobalData.

  GlobalData 04.14.20
  

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  COVID-19 is Exposing the Fragility of Global Supply Chains

  Pandemic likely will prompt healthcare companies to reshape supply chains to strengthen the risk management process and resilience.

  GlobalData 04.13.20
  

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  Non-Invasive Ventilators Offer Life-Saving Treatment for Less Severe COVID-19 Patients

  Manufacturers could produce more than 60,000 per week, easing pressure on the system.

  AdvaMed 04.09.20
  

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  West Pharmaceutical Hires Stewart Campbell

  As Vice President and General Manger for Asia Pacific region.

  West Pharmaceutical 04.09.20
  

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  3M, Trump Administration to Import 166.5M Respirators into U.S.

  Imports to supplement the 35 million N95 respirators 3M currently produces in U.S. per month.

  Business Wire 04.07.20
  

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  3M Responds to Trump's Defense Production Act Order

  There are significant humanitarian implications of ceasing respirator supplies to healthcare workers in Canada and Latin America.

  Business Wire 04.06.20
  

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  Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic

  A reminder of what manufacturers should keep in mind during this turbulent time.

  Online Exclusives Veleka Peeples-Dyer and Khelin Aiken, Baker McKenzie 04.02.20
  

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• Digital Health
  

  Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

  Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.

  Michael Barbella, Managing Editor 04.01.20
  

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  COVID-19’s Lasting Impact on Healthcare’s Supply Chain

  While some have speculated about what will happen after this passes, the one area that most interests me is the medical device and healthcare supply chains.

  Sean Fenske, Editor-in-Chief 04.01.20
  

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• Diagnostics
  

  BD, BioMedomics Launch Test to Detect Exposure to COVID-19

  Point-of-care blood test detects evidence of present or past exposure in 15 minutes.

  BD 03.31.20
  

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• Diagnostics
  

  FDA OKs BGI's Real-Time SARS-CoV-2 Test

  Kits are currently being distributed to more than 70 countries and regions worldwide.

  PR Newswire 03.27.20
  

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• Diagnostics
  

  Mologic, Partners Begin Validation for COVID-19 Point-of-Need Diagnostic Test

  Prototypes will be sent to labs in the United Kingdom, Senegal, Spain, China, Malaysia, and Brazil for priority validation.

  Mologic Ltd. 03.26.20
  

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• Diagnostics
  

  Hardy Diagnostics Releases Rapid Test for COVID-19

  Partnership with Autobio Diagnostics enables company to become a U.S. supplier of one-step lateral flow assay that detects both IgG and IgM antibodies.

  Newswire 03.25.20
  

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  Nu-Med Plus Monitoring Outcomes on COVID-19 Treatment Trials

  Inhaled nitric oxide has been used in the past as a supportive measure in treating coronavirus-infected patients.

  Globe Newswire 03.25.20
  

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  3M, GE Healthcare Partner with Ford to Speed Respirator, Ventilator Production

  Getting urgently needed equipment and supplies to healthcare workers and COVID-19 patients.

  Business Wire 03.24.20
  

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• Diagnostics
  

  COVID-19 Rapid Testing Technology Developed by Oxford Scientists

  The new test is based on a technique that provides results in just half an hour, over three times faster than the current method.

  University of Oxford 03.18.20
  

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  FDA Commissioner Addresses AdvaMed Board of Directors on Coronavirus

  Medtech's largest trade association is working with the agency to ensure healthcare workers have the necessary equipment to fight the virus.

  AdvaMed 03.18.20
  

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  Getinge Increases Ventilators Production Capacity

  To meet the global demand, the company will temporary increase its production of ventilators by 60 percent in 2020 compared to 2019.

  Getinge 03.17.20
  

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• Diagnostics
  

  New COVID-19 Diagnostic Test Could Confirm Virus in Under One Hour

  The test may be able to confirm the SARS-CoV-2 virus at the point of care (patient's bedside).

  PR Newswire 03.17.20
  

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• Diagnostics
  

  Survey: Lack of Access to Diagnostic Tests Has Driven Spread of Coronavirus

  CDC reports that more than 22,000 specimens or nose swabs have been taken in the U.S. since the outbreak began, far below other developed countries.

  GlobalData 03.17.20
  

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  Senators Introduce Bill to Address Medical Supply Vulnerabilities

  Bill would study and develop action plan to address U.S. dependence on foreign-made medical equipment and boost domestic production and supply.

  Lamar Alexander (R-TN) and Dick Durbin (D-IL) 03.12.20
  

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• Electronics
  

  TE Connectivity Acquires Majority Share of First Sensor AG

  The firm now holds 71.87 percent shares of First Sensor.

  TE Connectivity 03.12.20
  

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  FDA Suspends Foreign Inspections

  The agency has postponed most foreign inspections through April, effective immediately.

  Food and Drug Administration 03.10.20
  

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• Diagnostics
  

  Coronavirus Test Developed for Hologic's Panther Fusion System

  German laboratory-developed test uses Panther Open Access functionality.

  Business Wire 03.05.20
  

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• Contract Manufacturing
  

  A Valuable Supply Chain Lesson, Courtesy of Coronavirus

  The deadly respiratory disease spreading like wildfire around the world is exposing major weaknesses in the global medtech supply chain.

  Michael Barbella, Managing Editor 03.04.20
  

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  Class Ir Device Manufacturers Must Keep Their Feet on the Gas

  The recent deadline extension for Class I reusable devices to comply with MDR is a relief, but these next four years will go by fast.

  Dan Fowler, Principal Scientist, WuXi Medical Device Testing 03.04.20
  

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  Developing a Plan for Unplanned Crises

  It is often assumed C-suite executives are well-trained for every situation and have all the answers, but life seldom adheres to a plan.

  Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 03.04.20
  

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  Dawn of a New Decade: Looking Ahead to Medtech’s Future

  The start of the '20s offers the industry an opportunity to build value through new tech., collaborations, clinical validations, and value-based outcomes.

  Mark Bonifacio, President, BCS LLC 03.04.20
  

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  Use of Endosurgery Devices in Laparoscopic Surgeries to Grow

  Increase is attributable to growth in use of surgical staplers, advancements in endomechanical devices, and a rise in various types of endosurgery.

  Transparency Market Research 03.04.20
  

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• Contract Manufacturing
  

  Medical Device Contract Manufacturing Market Forecasted to Expand

  Reportlinker predicts a high single digit CAGR from 2019 to 2026.

  ReportLinker 03.02.20
  

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• Diagnostics
  

  Global In-Vitro Diagnostics Industry Forecasted to Grow

  New report estimates the industry will expand with a CAGR of 5.8% from 2020 to 2027.

  PR Newswire 03.02.20
  

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  Localization Strategy Key to Competing in Chinese Medtech Market

  China is working to increase the share of domestically produced medical devices in hospitals to 70 percent by 2025.

  GlobalData 02.28.20
  

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  FDA Offers Coronavirus Update Regarding Product Safety

  The agency outlines the steps it will take to ensure the quality of foreign products.

  U.S. Food and Drug Administration 02.25.20
  

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• Diagnostics
  

  Anitoa Introduces Rapid, On-Site Test for Coronavirus

  Patient samples like throat or nasal swaps can be applied directly to the portable instrument without the need to freeze, transport and thaw the samples.

  PR Newswire 02.25.20
  

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