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Journal Cover Medtech Insight
  [2 followers]  Follow
    
   Full-text available via subscription Subscription journal  (Not entitled to full-text)
   ISSN (Print) 1876-8008
   Published by Informa plc Homepage  [9 journals]
  • Legislation Would Streamline Risk-Classification For Device Accessories
    • Abstract: A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would...      Related Stories
      US FDA Still Waiting For Cures Money, Woodcock Says
      Unapproved Indications Guidance Proves Controversial
      Number To Know…11.2 Billion 
      PubDate: Thu, 27 Apr 2017 10:51:47 GMT
       
  • US FDA Still Waiting For Cures Money, Woodcock Says
    • Abstract: When asked about Cures-related hiring, the FDA drug-center director says to her knowledge, no funding has been received yet.      Related Stories
      Unapproved Indications Guidance Proves Controversial
      Number To Know…11.2 Billion
      HHS Pressured By Lawmakers To Release Pandemic-Flu Plan 
      PubDate: Wed, 26 Apr 2017 17:37:11 GMT
       
  • Unapproved Indications Guidance Proves Controversial
    • Abstract: FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved...      Related Stories
      US FDA Still Waiting For Cures Money, Woodcock Says
      Number To Know…11.2 Billion
      HHS Pressured By Lawmakers To Release Pandemic-Flu Plan 
      PubDate: Wed, 26 Apr 2017 17:25:13 GMT
       
  • VIDEO: Webinar: What's Ahead For IVD Regulations In The EU And US
    • Abstract: In this hour-long webinar, Medtech Insight?s Amanda Maxwell and David Filmore, and In Vivo?s Ashley Yeo discuss regulatory reforms in the works for...      Related Stories
      Advent Of Artificial Pancreas Tech To Galvanize Fast-Growing Diabetes Market
      Stent Leaders Pull Out Of India Amidst Price Cap Storm; Opportunity For The Dragon?
      What?s In the Official Journal Of The EU? Fake News? 
      PubDate: Wed, 26 Apr 2017 14:21:57 GMT
       
  • Number To Know…11.2 Billion
    • Abstract: The estimated size of the global diabetes management will be $11.2bn by 2020.      Related Stories
      HHS Pressured By Lawmakers To Release Pandemic-Flu Plan
      The Patient Perspective: Upcoming US FDA Device Center Studies Put Device-Users In Front Seat
      FDA Warning Letter Roundup & Recap – April 25, 2017 
      PubDate: Wed, 26 Apr 2017 11:00:36 GMT
       
  • Advent Of Artificial Pancreas Tech To Galvanize Fast-Growing Diabetes
           Market
    • Abstract: The global diabetes management devices market is expected to exceed $11.2bn by 2020, driven largely by the rising diabetes epidemic...      Related Stories
      Advent Of Artificial Pancreas Tech To Galvanize Fast-Growing Diabetes Market
      VIDEO: Webinar: What?s Ahead For IVD Regulations In The EU And US 
      PubDate: Wed, 26 Apr 2017 09:00:12 GMT
       
  • HHS Pressured By Lawmakers To Release Pandemic-Flu Plan
    • Abstract: Two House Committee leaders are asking HHS Secretary Tom Price about the current status of an overdue pandemic influenza preparedness...      Related Stories
      Legislation Would Streamline Risk-Classification For Device Accessories
      US FDA Still Waiting For Cures Money, Woodcock Says
      Unapproved Indications Guidance Proves Controversial 
      PubDate: Tue, 25 Apr 2017 16:39:44 GMT
       
  • The Patient Perspective: Upcoming US FDA Device Center Studies Put
           Device-Users In Front Seat
    • Abstract: A patient?s point of view is paramount as the Center for Devices and Radiological Health embarks on a plan to...      Related Stories
      FDA Warning Letter Roundup & Recap – April 25, 2017
      Number To Know…317
      Emerging Markets Welcome Rise Of Robots, But UK Skeptical 
      PubDate: Tue, 25 Apr 2017 16:15:01 GMT
       
  • FDA Warning Letter Roundup & Recap – April 25, 2017
    • Abstract: US FDA did not release any device-related warning letters the week of April 25.      Related Stories
      Number To Know…317
      Emerging Markets Welcome Rise Of Robots, But UK Skeptical
      BD, CR Bard Merger To Create Vascular Access Device Giant 
      PubDate: Tue, 25 Apr 2017 14:20:40 GMT
       
  • Stent Leaders Pull Out Of India Amidst Price Cap Storm; Opportunity For
           The Dragon'
    • Abstract: The storm in India over price caps on stents has not shown any signs of abating, with foreign firms seeking...      Related Stories
      What?s In the Official Journal Of The EU? Fake News?
      Snapshot: Device Recalls Tick Up Only 1% In 2016 Despite Midyear Surge
      AUDIO: Device Week – April 21, 2017 
      PubDate: Tue, 25 Apr 2017 11:20:20 GMT
       
  • Number To Know…317
    • Abstract: Becton Dickinson has agreed to pay $317 per share for CR Bard, valuing the total transaction at $24bn.      Related Stories
      Emerging Markets Welcome Rise Of Robots, But UK Skeptical
      BD, CR Bard Merger To Create Vascular Access Device Giant
      Feds Holding Workshop on Medical Device Cybersecurity Gaps 
      PubDate: Tue, 25 Apr 2017 10:36:22 GMT
       
  • Emerging Markets Welcome Rise Of Robots, But UK Skeptical
    • Abstract: New research from Pricewaterhouse Coopers, PwC, has found that emerging economies are more willing to embrace the use of AI...      Related Stories
      Number To Know…317
      BD, CR Bard Merger To Create Vascular Access Device Giant
      Feds Holding Workshop on Medical Device Cybersecurity Gaps 
      PubDate: Tue, 25 Apr 2017 06:52:04 GMT
       
  • BD, CR Bard Merger To Create Vascular Access Device Giant
    • Abstract: Becton Dickinson has reached a definitive agreement to acquire CR Bard for $24bn. BD says Bard?s product portfolio gives it...      Related Stories
      Feds Holding Workshop on Medical Device Cybersecurity Gaps
      New Combination Product Registration Rules Coming To Malaysia
      MedTech Europe?s John Brennan Moves On At Critical Time For Industry 
      PubDate: Mon, 24 Apr 2017 20:48:09 GMT
       
  • Feds Holding Workshop on Medical Device Cybersecurity Gaps
    • Abstract: Following several cases highlighting medical device cybersecurity vulnerabilities and concerns from experts and lawmakers about the federal government?s response, FDA...      Related Stories
      Number To Know…317
      Emerging Markets Welcome Rise Of Robots, But UK Skeptical
      BD, CR Bard Merger To Create Vascular Access Device Giant 
      PubDate: Mon, 24 Apr 2017 17:47:52 GMT
       
  • Snapshot: Device Recalls Tick Up Only 1% In 2016 Despite Midyear Surge
    • Abstract: A count of fiscal year 2016 recalls provided by the agency shows that there were 43 high-risk class I (4%)...      Related Stories
      AUDIO: Device Week – April 21, 2017
      Starts & Stops: ICS? Emblok Medtronic?s Arctic Front, Abbott?s Absorb, Boston Scientific?s S-ICD
      New Bodies To Emerge Under Revised EU Governance Structure 
      PubDate: Mon, 24 Apr 2017 15:00:24 GMT
       
  • What's In the Official Journal Of The EU' Fake News'
    • Abstract: A text has appeared in the Official Journal of the EU that is raising some questions over whether the new...      Related Stories
      Snapshot: Device Recalls Tick Up Only 1% In 2016 Despite Midyear Surge
      AUDIO: Device Week – April 21, 2017
      Starts & Stops: ICS? Emblok Medtronic?s Arctic Front, Abbott?s Absorb, Boston Scientific?s S-ICD 
      PubDate: Mon, 24 Apr 2017 14:19:51 GMT
       
  • New Combination Product Registration Rules Coming To Malaysia
    • Abstract: New guidance explains how Malaysia’s impending rules for registering combination products will work when they come into force in July...      Related Stories
      Number To Know…317
      Emerging Markets Welcome Rise Of Robots, But UK Skeptical
      BD, CR Bard Merger To Create Vascular Access Device Giant 
      PubDate: Mon, 24 Apr 2017 11:53:01 GMT
       
  • MedTech Europe's John Brennan Moves On At Critical Time For
           Industry
    • Abstract: After nearly nine years, MedTech Europe?s John Brennan is leaving the medical device and diagnostics trade association. This is a...      Related Stories
      Number To Know…317
      Emerging Markets Welcome Rise Of Robots, But UK Skeptical
      BD, CR Bard Merger To Create Vascular Access Device Giant 
      PubDate: Mon, 24 Apr 2017 11:12:21 GMT
       
  • Number To Know…60
    • Abstract: Diabeloop is expecting to enroll 60 pagients in a 12-center study of its artificial pancreas system. Results from the study...      Related Stories
      BD, CR Bard Merger To Create Vascular Access Device Giant
      Feds Holding Workshop on Medical Device Cybersecurity Gaps
      New Combination Product Registration Rules Coming To Malaysia 
      PubDate: Mon, 24 Apr 2017 10:29:22 GMT
       
  • Nanjing BioPoint Shoots For 2018 Double POC Launch; Seeks $10m
    • Abstract: A China-based IVD company, spun out of an Australian medical research institute, is seeking investors to support its plans for...      Related Stories
      Number To Know…317
      Emerging Markets Welcome Rise Of Robots, But UK Skeptical
      BD, CR Bard Merger To Create Vascular Access Device Giant 
      PubDate: Mon, 24 Apr 2017 09:15:55 GMT
       
 
 
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