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Quality Assurance When Supply Chain Disruptions Arise
From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20
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ERT and Science 37 Partner to Deliver High-Quality Data During Virtual Trials
Alliance enables trial sponsors to improve imaging, respiratory, and cardiac safety data quality while reducing patient burden and risk.ERT 10.08.20
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Software & IT
Adopting a Data-Driven Approach to Quality with an MDQMS
FlexLogical is making quality a competitive advantage through its software solution.Online Exclusives Jon Speer, Founder and VP of QA/RA, Greenlight Guru 09.24.20
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Beaufort CRO Names Senior VP of Regulatory and Quality
Industry thought leader and veteran strategist to lead the further expansion of global regulatory and quality services.Business Wire 09.11.20
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Software & IT
Avoiding the Ripple Effect of Bad Data: Quality and Manufacturing
Part 1: Why going paperless is essential.Online Exclusives Terrance Holbrook, Director of Product at MasterControl 06.17.20
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ISO 13485 Remote Audits: Views from Both Sides of the Table
Remote audits have been a standard practice for low-risk suppliers or in the cases where restrictions existed in entering certain parts of the world.Jim Shore, Quality Lean Solutions, and Neel Patel, Florida Anodize System & Technologies 06.04.20
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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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R&D & Design
Medtech R&D Must Address Outcomes in Value-Based Care
Clinical requirements are no longer the only cornerstone of medical device development.Online Exclusives Michael Barbella, Managing Editor 04.24.20
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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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Cardiovascular
FDA Lifts U.S. Injunction on Philips’ Defibrillators
This business has been operating under a consent decree with the FDA since November 2017.Philips 04.24.20
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Aria CV Announces $31 Million in Series B Funding
Money will support the Aria CV Pulmonary Hypertension System Feasibility Study.Business Wire 04.24.20
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Diagnostics
Siemens Healthineers to Expand SARS-CoV-2 Testing
With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.Siemens Healthineers 04.23.20
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Diagnostics
Enzo Biochem Launches COVID-19 Diagnostic Test
Proprietary molecular diagnostic kits offer improved scale, throughput, and sensitivity.Business Wire 04.23.20
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Cardiovascular
VisCardia's Heart Failure Therapy Gains Breakthrough Designation
Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.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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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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Diagnostics
FDA Clears Siemens Healthineers' Aidan AI
The latest technology enables new features and enhanced security.Siemens Healthineers 04.22.20
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Itamar Medical to Evaluate Impact of CPAP Therapy on Patients with COVID-19
The clinical trial will assess the efficacy of CPAP in COVID-19 confirmed or suspected patients.Globe Newswire 04.22.20
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EarlySense Names New Senior Vice President of Strategic Partnerships
Former Cerner and Allscripts executive joins company to deepen existing relationships and broaden new global opportunities.EarlySense 04.22.20
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Non-Traditional Thinking Can Help Drive Medtech R&D
Non-healthcare-related companies like Google, Amazon, and Apple can provide the medtech industry with unique solutions to age-old problems.Online Exclusives Michael Barbella, Managing Editor 04.21.20
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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 Update: COVID-19 Antibody Test Validation and Education
Results from these tests can help identify who has been infected and developed antibodies.U.S. Food and Drug Administration 04.20.20
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Study: UV Technology Raises Standard in Disinfecting ORs, Medical Equipment
Hospitals use established protocols for cleaning and disinfecting ORs and medical equipment with chemical wipes after each case.Business Wire 04.20.20
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Diagnostics
ELITechGroup MDx, OSANG Healthcare Receive Emergency Use Authorization for COVID-19 Test Kits
Test delivers qualitative results within hours.PR Newswire 04.20.20
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Diagnostics
Mologic Launches New Lab-Based COVID-19 Antibody Tests
With manufacturing support from Omega Diagnostics, the laboratory-based test aims to deliver up to 46,000 results per day.Mologic Ltd. 04.20.20
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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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FDA Continues User-Fee Related Reviews Through COVID-19
FDA is extending response due date for 510(k), PMA, HDE, and De Novo applications by 90 days.U.S. Food and Drug Administration 04.17.20
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Diagnostics
Gold Standard Diagnostics Releases Three COVID-19 Antibody Tests
The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories.Business Wire 04.17.20
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R&D & Design
Smaller Businesses Beget Better Innovation
Despite their global sales reach, large firms tend to focus on nurturing existing product lineups.Online Exclusives Michael Barbella, Managing Editor 04.16.20
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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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HeartVista Forms Medical and Scientific Advisory Board
Governing body comprised of leaders from Stanford University and the University of Wisconsin.Business Wire 04.16.20
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Digital Health
Viz.ai Adds Next-Generation Functionality to Artificial Intelligence Stroke Platform
New capabilities allow the stroke care team to synchronize care from stroke code notification to the post-acute care period.Business Wire 04.16.20
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Surgical
FDA OKs Disposable Fog-Free Articulating 5mm Laparoscope
Can be used for minimally invasive abdominal and thoracic surgery.Videos PR Newswire
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Agiliti Acquires Mobile Instrument Service & Repair
Deal expands and extends Agiliti’s clinical equipment service offering.Business Wire 04.15.20
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Philips Releases Respironics E30 Ventilator to Help Free up ICUs
Emergency use ventilator with visual and audible alarms allows for high-flow oxygen to support COVID-19 patients.Philips 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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Patient Monitoring
PulseCam Maps Blood Flow
New Rice U. tech could let doctors monitor blood perfusion in real time with a camera.Rice University 04.13.20
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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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Fitness Tracker Company Manufacturing N95 Equivalent Face Masks
The masks will be distributed to health care workers, law enforcement, food handlers, and the general public.PR Newswire 04.13.20
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Georgia Man Arrested in Multi-Million Dollar COVID-19 Scam
Suspect tried secure orders from the Department of Veterans Affairs for 125 million face masks and other PPE totaling more than $750 million.U.S. Department of Justice 04.13.20
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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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Cardiovascular
Abbott's TriClip Transcatheter Tricuspid Valve Repair Gains CE Mark
The device is delivered to the "forgotten heart valve" through the femoral vein in the leg.Abbott 04.09.20
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Machining & Laser Processing
New Methods 5-Axis Bridge-Type Machining Center Offers High Performance
Machine can perform full five-axis precision machining of challenging parts, significantly reducing the need for multiple setups.Methods Machine Tools 04.09.20
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3D/Additive Manufacturing
UCLA Bioengineers Create Reusable COVID-19 Face Shields
Device’s headband can be mass-produced using 3D injection molding; clear plastic shield is made by laser cutting.Brianna Aldrich and Christine Wei-li Lee, UCLA Newsroom 04.08.20
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Cardiovascular
BioVentrix Names Co-Principal Investigator for Transcatheter Device Trial
Newly-appointed leader has served as the national or international principal investigator for more than 100 national and international randomized trials.Business Wire 04.08.20
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MedLite ID Appoints New Board Chairman, COO/CFO
Company founder is associated with over 100 patents ranging from mechanical devices, dental products, medical devices, and medical software products.PR Newswire 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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Software & IT
Remote Check Solution for Cochlear Implants Wins FDA Nod
Amid COVID-19 pandemic, remote healthcare solutions are a priority now more than ever.PR Newswire 04.07.20
