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Contract Manufacturing
Quality in Component Fabrication—A Medtech Makers Q&A
Hobson & Motzer’s Bruce Dworak speaks to the company’s constant view of quality when serving the needs of medical device manufacturers.
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Halo Labs Launches Aura CL for Cell Therapy Product Quality
Aura CL is the first system specifically designed to quantify cell aggregates and ID cell vs non-cell contaminants.PR Newswire 06.14.21
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Contract Manufacturing
Maintaining Quality in the Fast-Paced Contract Manufacturing Industry
A cautionary tale from pharma offers lessons to device manufacturers about the dangers of a quality system that isn’t digital.Online Exclusives Dale Thompson, Staff Writer, MasterControl 05.27.21
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Hologic Launches Project Health Equality
Aims to address the barriers that prevent Black and Hispanic women in the U.S. from receiving the same quality health care as white women.Charles Sternberg, Assistant Editor 05.17.21
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Software & IT
Digitization Streamlined Quality and Production: A Case Study
Recognizing that managing a paper-based quality system was no longer practical, the company took steps to modernize with digital solutions.Online Exclusives David Butcher, Staff Writer, MasterControl 05.05.21
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Embedding Risk-Based Thinking into Quality Efforts
Controlling risk is an important requirement for companies developing regulated products.Online Exclusives David Jensen, Staff Writer, Master Control 05.04.21
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Surgical
High-Quality Materials and Precision Engineering in Robotic Medical Technology
The XACT ACE Robotic System is designed to be able to deliver an instrument to a target within 1.7-mm average accuracy on the first insertion.Chen Levin, CEO, XACT Robotics 05.03.21
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Software & IT
How AI-Empowered Quality Systems Shorten the Journey to Proactive Quality
A look into Quality 4.0’s impact on achieving proactive quality, the applications of AI in the life sciences, and use cases for the AI-empowered quality system.Steve McCarthy, Vice President of Digital Innovation, Sparta Systems 05.03.21
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Software & IT
Three Future Trends and Opportunities in Quality Assurance
As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.Online Exclusives David Jensen, Staff Writer, MasterControl 04.09.21
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Software & IT
Adopting a Data-Driven Quality Model
Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.Online Exclusives David Jensen, Staff Writer, MasterControl 04.09.21
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Software & IT
Digital Transformation for Quality and Manufacturing
The pandemic has illustrated the importance of a transition to digital solutions for medical device and other life sciences manufacturers.Online Exclusives Jon Beckstrand, CEO, MasterControl 04.08.21
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Philips Survey Reveals COVID-19’s Negative Impact on Sleep Quality, CPAP Use
Seventy percent of people surveyed have experienced one or more new sleep challenges since the start of the pandemic, data show.Michael Barbella, Managing Editor 04.05.21
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Contract Manufacturing | Software & IT | Testing
Quality & Regulatory Solutions for the FDA Regulated Industries
EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.
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Software & IT
Using Quality as an Advantage in 2021
Report finds despite pandemic, 79 percent of medical device professionals expect modest or strong revenue growth in 2021.Online Exclusives Jon Speer, Founder, Greenlight Guru 03.25.21
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Software & IT
2021: The Year for Insights Into Quality Data
For users of paper-based quality systems, data can seem overwhelming and disorganized.Online Exclusives Sarah Beale, Staff Writer, MasterControl 03.11.21
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Chronic Disease | Digital Health | Software & IT
Brainlab Buys Mint Medical to Boost Quality of Clinical Routine, Research Data
Will improve radiological report automation through AI and anatomical mapping, create unparalleled longitudinal data.Sam Brusco, Associate Editor 03.10.21
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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
