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Diagnostics
Rapid Antigen Tests Manufacturer Acquires BIOLAB
Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.Innova Medical Group Inc. 01.14.21
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Diagnostics
Manufacturer of Rapid Antigen Tests Acquires BIOLAB
BIOLAB acquisition will create jobs and increase Innova's U.S. COVID-19 testing capability.PR Newswire 12.18.20
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Manufacturer Develops New Ventilator Sensor
The sensor took only 14 weeks from concept, through validation, to manufacture and delivery.Hummingbird Sensing Technology 12.07.20
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Survey: Medical Device Repair Professionals Fix Equipment Manufacturers Cannot Remedy
Finding underscores FDA's conclusion that manufacturer technicians provide 'high quality, safe, effective servicing' of medical devices.U.S. PIRG 11.18.20
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Contract Manufacturing | Electronics
Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers
But many companies are hesitant to start new development projects while the coronavirus is still rampant.Online Exclusives Michael Barbella, Managing Editor 10.05.20
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Six Reimbursement Tips For Medtech Manufacturers
Product development and regulatory pathway are important, but if no one is paying for your product, how will it succeed?Online Exclusives Katherine Rundell, Technical Writer, Academic Writing Services 09.29.20
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Manufacturer’s Version of Rice Ventilator Gains EUA
Stewart & Stevenson Apollo ABVM receives EUA during COVID-19 pandemic as bridge for patients in needMike Williams, Rice University 08.05.20
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Diagnostics
5 Trends Shaping Medical Imaging Manufacturers Need to Know
New life-supporting imaging equipment designs must incorporate modern patient, physician, and technician demands.Online Exclusives Megan Ray Nichols, Science Writer; Editor, Schooled By Science 06.17.20
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Contract Manufacturing
Shopping Smart: What to Look for in a Contract Manufacturer
A contract manufacturing organization can help shoulder the workload of bringing a new device to market.Claudio Hanna and Jennifer Ponti, Web Industries Inc. 06.04.20
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Contract Manufacturing
Reshoring Checklist for Manufacturers—the Math Works!
Reshoring manufacturing back to the USA isn't just a trend due to COVID. Look at the math to see why reshoring adds up.
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Medtech’s Battle on Multiple Fronts Against COVID-19
From PPE to testing to ventilator solutions, medtech firms are trying to find answers for healthcare’s needs against the novel coronavirus.Online Exclusives Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20
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Surgical
FDA Update on Essure Postmarket Activities
All unused Essure devices of which Bayer is aware have been returned to the company.U.S. Food and Drug Administration 04.27.20
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Sporting Goods Brand Now Making Millions Of Face Masks
Company will donate face masks to those in need including hospice workers, nursing homes, assisted living facilities, and first responders.StringKing 04.27.20
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Hasbro, Cartamundi Partner to Produce Personal Protective Equipment
Companies to donate 50,000 face shields per week to local hospitals in Massachusetts and Rhode Island.Business Wire 04.27.20
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Ortho's Second COVID-19 Antibody Test With 100 Percent Specificity Debuts
Tests will aid in responsible back-to-work assessment, according to manufacturer.Ortho Clinical Diagnostics 04.27.20
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Materials
Plastics and Medtech: Annual Industry Survey Results
Medical device manufacturers prefer domestic plastics manufacturing and many use thermoforming on a project.Online Exclusives Jason Middleton, Vice President of Sales & Development, Ray Products 04.24.20
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Kurin Receives FDA 510k Clearance for Its Push-Button Needle
Company's technology automatically and passively sidelines potential contaminants during blood culture collection.Business Wire 04.24.20
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Endonovo Therapeutics Introduces Support of SofPulse With New Patient Brace
The brace allows site-specific application and promotes ease of use for patients and medical professionals when using the SofPulse device.Globe Newswire 04.23.20
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Diversified Plastics Increases Capacity of Acceleration Station to Meet Manufacturing Demand
The Station’s engineering and production teams work closely with customers to save time and money by optimizing parts for digital manufacturing.Diversified Plastics Inc. 04.23.20
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Molding
Mack Molding, Health System Partner to Develop Face Mask Alternative
Within two weeks, the team fabricated an attachment to a snorkeling scuba mask.Mack Molding 04.22.20
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FDA Further Eases Burden on N95 Manufacturers
Nevertheless, demand for face masks continues to outstrip supply.GlobalData 04.21.20
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MPE Launches an Emergency Medical Cart to Meet Critical Ventilator Need
Company went from napkin sketch to market-ready product in only 10 days.PR Newswire 04.20.20
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Contract Manufacturing | Diagnostics
Medtech Matters: AdvaMed's Scott Whitaker on Medtech's COVID-19 Response
MPO Editor-in-Chief Sean Fenske speaks with Scott Whitaker, AdvaMed President and CEO, about how the medtech industry is assisting in the COVID-19 effort.Sean Fenske, Editor-in-Chief 04.17.20
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Surgical | Testing
Medical Robots: Assessing Safety and Performance in a Growing Field
Be aware of potential hazards robots may present and testing options to address them.Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20
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Diagnostics
Sense Biodetection Accelerates Instrument-Free COVID-19 Diagnostic Test
Scale-up with Phillips-Medisize is underway to ensure timely delivery and distribution.Sense Biodetection Limited 04.17.20
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Molding
Vaupell Midwest Earns MedAccred Accreditation for Plastic Injection Molding
MedAccred is an oversight program designed to provide manufacturing supply-chain oversight for OEMs looking to partner with Contract Manufacturers.Vaupell Midwest 04.16.20
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Tolomatic Develops Open-Source, Ventilator Actuation Prototypes
The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.Tolomatic 04.13.20
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Mike on Medtech: COVID-19, Part 2
Mike Drues and Sean Fenske discuss issues involved with misinformation around products to help treat COVID-19 and relaxed regulatory rules.Sean Fenske, Editor-in-Chief 04.08.20
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ZVerse Working to Produce 20 Million Face Shields
Small digital manufacturing company pivots to support COVID-19 response.Globe Newswire 04.08.20
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Pentax Medical to Pay $43 Million Over Misbranded Endoscopes
Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.U.S. Department of Justice 04.08.20
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Software & IT
Seeking Software Partners During a Crisis
The COVID-19 pandemic has caught many unprepared to handle increased challenges, leaving them to find assistance.Online Exclusives Svetlana Anishchenko, Director of Marketing, Auriga Inc. 04.07.20
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Surgical
Olympus' Non-Surgical BPH Device Wins FDA De Novo
The iTind flexible three-strut nitinol device can be placed during an in-office procedure.Olympus 04.06.20
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MIT Begins Mass Manufacture of Disposable Face Shields
A team from MIT has designed disposable face shields that can be mass-produced.Videos Mary Beth Gallagher, Department of Mechanical Engineering, Massachusetts Institute of Technology
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Tru-Form Plastics Develops Face Shield for COVID-19 Fight
Southern California manufacturer producing over 100,000 protective face shields per week with investment plans for greater production capacity.Tru-Form Plastics 04.06.20
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Polyzen Helps to Address Shortage of PPE
Commits to assist manufacturers, hospitals, and other healthcare facilities in getting the supplies they need.Polyzen 04.03.20
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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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Diagnostics
Sense Accelerates Instrument-Free Molecular Diagnostic Test for COVID-19
Pioneering new class of diagnostic product will transform fight against pandemic.Phillips-Medisize 04.02.20
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Diagnostics
Haemonetics Acquires enicor to Expand Advanced Viscoelastic Testing
Haemonetics gains ClotPro, a new generation whole blood coagulation testing system.PR Newswire 04.02.20
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Diagnostics
PCR Biosystems Works to Ensure Availability of COVID-19 Test Reagents
Company has the capacity to manufacture enough reagent daily for 4 million reactions, which is sufficient for millions of diagnostic tests.PCR Biosystems 04.02.20
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Mike on Medtech: COVID-19, Part 1
Mike Drues and Sean Fenske discuss Emergency Use Authorization and the potential problems with non-medical device manufacturers producing ventilators.Sean Fenske, Editor-in-Chief 04.01.20
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The Challenge and Opportunity in Corporate Environmental Sustainability Efforts
One company shares its experiences and outcomes with ongoing efforts toward a focus on environmental stewardship.Neil Peterson, Alisha Jerauld, CPA and Matt Wold, Merit Medical Systems Inc. 04.01.20
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A Manufacturer’s Secret Weapon: R&D Tax Credits
For small and medium-sized medical device manufacturers, qualifying for the tax credits could result in an unexpected windfall.Chris Lake, President, R&D Tax Credit Consultant 04.01.20
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Software & IT
Validating Your QMS the ‘EZ Way’
Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.James Shore and Roxana Rosales 04.01.20
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Tubing & Extrusion
Pathways to Care: Tubing Technologies
Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.Mark Crawford, Contributing Writer 04.01.20
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R&D & Design
Top 10 Considerations for Medtech Inventors
If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.Ryan Connell and Doug Portnow, Schwegman Lundberg & Woessner 04.01.20
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The Economics of a Sound Regulatory Strategy
While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20
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Second Sight Announces Employee Layoffs
An intent to wind down operations and appointment of Matthew Pfeffer as Acting CEO.Second Sight 03.31.20
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CORRECTION: Bodysphere's Two-Minute Serological Test Kit To Detect Novel Coronavirus
Company incorrectly indicated the test had acquired an Emergency Use Authorization from the FDA.Sean Fenske, Editor-in-Chief 03.31.20
