Search Results for 'safety'

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  Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon

  No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.

  Royal Philips 12.03.20
  

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• Cardiovascular
  

  Study: Exceptional Safety, Procedural Success With Coronary Orbital Atherectomy

  Data show OAS to be safe and successful in streamlining treatment for patients with the most significant coronary disease.

  Business Wire 11.24.20
  

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  Dental Markets Need Safety Innovations to Accelerate Recovery

  Dental devices don’t have the saving grace of being used in any part of the COVID-19 treatment pathway, making recovery from the pandemic a challenge.

  GlobalData 10.01.20
  

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  AdvaMed Launches Responsible Advertising for Patient Safety Website

  Aims to drive and enhance awareness of the dangers of misleading ads for medtech litigation.

  AdvaMed 09.23.20
  

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• Patient Monitoring
  

  Masimo Expands the Masimo SafetyNet Remote Patient Management Solution

  The Radius Tº Wearable Temperature Sensor automates remote monitoring of patient temperature status.

  Business Wire 09.21.20
  

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• Electronics
  

  Designing for Safety with Specialist Resistors

  How resistors for high voltage and surge medical applications reduce risk in the new ‘healthcare anywhere’ scenario.

  Online Exclusives Stephen Oxley, Business Development Engineer, TT Electronics 09.14.20
  

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• Cardiovascular
  

  Data Reconfirms Long-Term Safety of Philips Stellarex Low-Dose Drug-Coated Balloon

  The mortality rate at four years shows no statistical difference between two patient groups.

  Royal Philips 08.27.20
  

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• 

  Study Confirms Safety, Durability of PROCEPT BioRobotics’ Aquablation Therapy

  Two-year follow-up data confirmed that Aquablation is a safe procedure with durable efficacy.

  Business Wire 07.27.20
  

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• Cardiovascular
  

  Study Affirms Safety of Two-Lead Optimizer System

  The two-lead device represents a significant advancement in the development of cardiac contractility modulation therapy for heart failure patients.

  Business Wire 06.10.20
  

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• 

  Patent for AI-powered Medical Device Safety Monitoring Granted in Indonesia

  The patent ensures rights to a system that enables AI-powered supervision of the functionality of mobile medical equipment with injection apparatus.

  news.cision.com 05.28.20
  

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• 

  Advancing Infection Prevention Tools

  The applications and benefits of porous polymer materials and components.

  Jack Chan, Global Marketing Director, Porex

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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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• 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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• 

  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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• 

  FDA Clears Bimini Health Tech's Dermapose Refresh Fat Transfer

  Dermapose Refresh is an all-in-one microfat transfer system.

  PR 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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• 

  Integrity Applications Closes $15 Million Private Placement

  Shares were sold for 40 cents each.

  Globe Newswire 04.22.20
  

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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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• Diagnostics
  

  FDA OKs LabCorp's At-Home COVID-19 Test Kit

  Permits testing of a sample collected from the patient’s nose using a designated self-collection kit.

  U.S. Food and Drug Administration 04.21.20
  

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• 

  Terumo's Mirasol Shows Efficacy Against Virus Causing COVID-19 in Plasma, Platelets

  The pathogen reduction system is designed to add an extra layer of safety to the blood supply.

  Terumo BCT 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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• Cardiovascular
  

  Transcatheter Tricuspid Valve Replacement System Gains Breakthrough Status

  Cardiovalve is first company to receive FDA early feasibility study approval for both tricuspid regurgitation and mitral regurgitation indications.

  Business Wire 04.17.20
  

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• 

  AptarGroup Seeking Emergency Authorization for Easy Mask Disinfection Process

  Process takes three hours and can be performed on-site at hospitals.

  AptarGroup Inc. 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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• 

  3M, Cummins Partner to Boost Powered Air Purifying Respirator Filter Production

  The 3M designed filters will be made in Cummins’ Neillsville, Wis. plant.

  Business Wire 04.15.20
  

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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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• 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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• Surgical
  

  Sharp Fluidics Acquires neoClose Laparoscopic, Robotic Port Closure Technology

  neoClose utilizes bio-absorbable anchors with a pre-attached suture.

  PR Newswire 04.08.20
  

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• Surgical
  

  FDA OKs Nitiloop's Microcatheter to Treat Chronic Total Occlusion

  Designed solely for antegrade approach, NovaCross is positioned to tap into the $500M CTO market.

  PR Newswire 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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• 

  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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• 

  Zimmer Biomet CEO Foregoing Salary During COVID-19 Crisis

  Bryan Hanson's salary forfeit is among many steps the company is taking to contain costs amid the pandemic.

  Zimmer Biomet 04.07.20
  

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• 

  SynDaver Manufactures Respirators to Help with Shortage

  The manufacturing process begins April 7.

  SynDaver 04.07.20
  

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• 

  Qosina Is the Trusted Provider of Single-Use Bioprocessing Components

  ...

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• 

  PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables

  Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.

  PhysIQ 04.07.20
  

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• 3D/Additive Manufacturing
  

  Materialise's 3D Printed Oxygen Mask Helps Ventilator Shortage

  COVID-19 solution brought to hospitals quickly and in full compliance with safety regulations.

  Videos Materialise

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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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• Diagnostics
  

  COVID-19 Patients Being Triaged, Assessed Using Two-Minute Breath-Based Gas Test

  The MediPines AGM100's breathing gas-based measurement can provide immediate respiratory data after the patient breathes into a breathing tube.

  PR Newswire 04.06.20
  

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• 

  Adopted Proposal Would Delay MDR One Year

  The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.

  European Commission 04.03.20
  

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• Diagnostics
  

  COVID-19 At-Home Test Ready for Validation Study

  Care Access Research will lead clinical trials of the coronavirus test.

  Care Access Research 04.03.20
  

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• Cardiovascular
  

  VADovations Secures Investment, Development Agreement for Percutaneous Endovascular Delivery System

  Product is designed to avoid open surgical implantation while addressing the limitations of current blood pumps.

  Business Wire 04.03.20
  

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• 

  Johnson & Johnson Pauses 2020 Medical Devices Business Review

  Coronavirus outbreak postpones review planned to take place March 13.

  PR Newswire 04.02.20
  

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• 

  FDA OKs Outset's Table System for Home Dialysis

  First new device cleared for home hemodialysis in 15 years.

  PR Newswire 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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• R&D & Design
  

  Examining the Usability of Medical Software

  Developers need to consider the ‘human factor’ when it comes to testing medical device software.

  Bruce Johnston, Senior Software Engineering Specialist, MedAcuity Software 04.01.20
  

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• 

  Medtech Innovation and Adaptation in a Changing Pharmaceutical Landscape

  The two primary industries driving healthcare innovation—pharmaceutical and medtech—are intrinsically intertwined.

  Tom McLean, VP, Development Engineering, R&D Innovation & Technology, West Pharmaceutical Services 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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