Featured
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'EpiWear' Wearable Could Halt Allergic Reactions
Engineering team prototypes EpiWear to keep emergency medication at hand at all times.Videos Mike Williams, Rice University
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Surgical
FDA Halts Sale of Pelvic Mesh in U.S.
FDA has determined the manufacturers, Boston Scientific and Coloplast, haven't demonstrated reasonable assurance of safety and effectiveness for these devices.U.S. Food and Drug Administration 04.16.19
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Electronics | Packaging & Sterilization | Testing
Transporting Lithium Batteries Used in Medical Devices
What you need to know about the UN 38.3 standard.Online Exclusives Rick Byczek, Global Director of Transportation Technologies, Intertek 04.16.19
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3D/Additive Manufacturing | Contract Manufacturing | Machining & Laser Processing | Surgical
MW Industries Acquires Marox and Sussex Wire
Both companies are suppliers of tight-tolerance, mission-critical components used in medical device, aerospace, and industrial applications.MW Industries Inc. 04.15.19
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24 Charged in $1.2B Medicare Telemedicine Fraud Scheme
Hundreds of thousands of elderly and/or disabled patients nationwide and abroad were lured into the criminal scheme.U.S. Department of Justice 04.10.19
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Surgical
Alcon Debuts as an Independent Company
Company completes separation from Novartis; began trading April 9 on SIX Swiss Exchange and NYSE.Business Wire 04.10.19
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B. Braun Medical Acquires NxStage Medical Inc.’s Streamline Bloodlines
The Streamline Bloodlines adds to the integrated line of dialysis products B. Braun’s Avitum division currently offers.Globe Newswire 04.08.19
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Digital Health | Neurological | Patient Monitoring
An AI Smartwatch that Detects Seizures
Every year worldwide, more than 50,000 otherwise healthy people with epilepsy suddenly die—a condition known as SUDEP.Videos TEDxBeaconStreet
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Contract Manufacturing | Surgical
Seisa Medical Acquires Burpee MedSystems
New Jersey-based Burpee MedSystems is a manufacturer of stents and delivery devices.Business Wire 04.05.19
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Digital Health | Software & IT
Telemedicine Stands to Offer New Horizons to the Healthcare Solutions Landscape
High-speed internet, affordable smartphones, and standardized phone operating systems have added an unexpected dimension to the idea of telemedicine.Online Exclusives Saipriya Iyer, Global Market Insights 04.04.19
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Diagnostics
Diagnosing the Cancer in Medical Imagery Security
Ben-Gurion University researchers first to show how hackers can dupe radiologists and AI software by manipulating lung cancer scans.Videos American Associates, Ben-Gurion University of the Negev
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Cardiovascular
Meeting Cardiac Stent Market Needs
Biotronik's PK Papyrus device was developed to provide physicians with a reliable covered stent that can be quickly deployed.Online Exclusives Michael Barbella, Managing Editor 04.04.19
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The Quest for Cake: Leveraging Quality as a Business Partner
The quality function is not only about maintaining compliance; rather, real-world savings can be realized through its adherence.Paul Robinson, Vice President of Operations, Quality Systems Consulting Services (QSCS) 04.03.19
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Cardiovascular | Contract Manufacturing | Diagnostics | Molding | Surgical
Once or Again? Single-Use Products Are Gaining Attention
Bolstered by recent study findings and their infection control prowess, the single-use device market is primed for growth.Michael Barbella, Managing Editor 04.03.19
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Cardiovascular | Surgical | Tubing & Extrusion
Challenging Channels: Tubing Innovations Enable Greater Device Capabilities
Technical innovations provided by tubing suppliers fulfill the various needs of medical device manufacturers.Mark Crawford, Contributing Writer 04.03.19
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Cardiovascular | Diagnostics | Digital Health | Patient Monitoring
Cardiac Care on the Can
Transitioning from reactive to proactive/preventive care could work wonders for the healthcare system. A proactive strategy is important for cardiovascular disease, the leading cause of death across the globe. According to a 2017 American Heart Asso…Sam Brusco, Associate Editor 04.03.19
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Cardiovascular
What’s New with TAVR?
Transcatheter aortic valve replacement (TAVR), once the last resort for patients so sick or elderly they were deemed unable to outlive surgical aortic valve replacement performed via open-heart surgery, has now been proven to offer benefits for young…Maria Shepherd, President and Founder, Medi-Vantage 04.03.19
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Software & IT
Quality Systems: It’s All Greek to Us
I admire people who love what they do. There’s a lot of truth to the oft-quoted Mark Twain observation: “Find a job you enjoy doing, and you will never have to work a day in your life.” For the most part, that applies to me. But…Dawn A. Lissy, President & Founder, Empirical 04.03.19
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Software & IT
Five Questions to Improve Your Requirements Management
Medical device developers spend years designing devices that help improve patient outcomes, which leads to millions of dollars invested in product development. If risk and requirements are not managed properly during development, it could result in a…Kevin Steigerwald, VP of Product & UX, Jama Software 04.03.19
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CAPA’s Impact on Compliance
You might be wondering why I’m writing about Corrective and Preventive Action (CAPA) in a regulatory column. What else, after all, can be said about CAPA that hasn’t already been articulated? Not much, but there is one thing: how importan…James A. Dunning, Principal, QPC Services LLC 04.03.19
- Premier Research Names New Medical Device Research and Regulatory Process Experts
- Global Patient Monitoring Market to Reach $10.4 Billion by 2023
- New ASTM International Standards Help Evaluate Medical Device Cleaning Brushes
- Fitbit and Solera Health Expand Partnership to Reduce Risk of Type 2 Diabetes
- Senseonics Appoints Chief Medical Officer
- FDA OKs Beckman Coulter's Early Sepsis Indicator
- BioSig Appoints Vice President of Engineering
- Medical Electronics Market to Surpass $169 Billion by 2025
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