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Journal Cover Medtech Insight
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   Full-text available via subscription Subscription journal
   ISSN (Print) 1876-8008
   Published by Informa plc Homepage  [9 journals]
  • QUOTED. Dec 13, 2017. Kyparissia Sirinakis.
    • Abstract: Check out what Kyparissia Sirinakis, managing partner of Epidarex Capital, had to say about misperceptions related to early-stage medtech...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      Elanix Teams With Dermacon To Develop New Wound-Care Devices 
      PubDate: Wed, 13 Dec 2017 00:35:40 GMT
       
  • In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
    • Abstract: As the 2017 window to fully repeal the medical device tax has all but closed, lawmakers and industry are now...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis.
      Elanix Teams With Dermacon To Develop New Wound-Care Devices 
      PubDate: Tue, 12 Dec 2017 22:08:15 GMT
       
  • US FDA Panel Votes 'No' On Barricade Implant To Stop
           Reherniation
    • Abstract: A US FDA Orthopedics Advisory Panel voted 8-5 that the benefits do not outweigh the risks of implanting Intrinsic Therapeutics...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Tue, 12 Dec 2017 18:19:48 GMT
       
  • Most IDEs Now Include Patient Survey Data, US FDA Says
    • Abstract: The agency?s ongoing focus on patient input is leading more sponsors to include patient-reported outcomes in pre-market studies, but FDA...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Tue, 12 Dec 2017 17:51:12 GMT
       
  • UK Device Manufacturers Must Contingency Plan For A Hard Brexit
    • Abstract: The compromise tone adopted last week by the UK government on key "phase 1" issues of an EU-UK Brexit deal...      Related Stories
      New Path For 510(k)s On US FDA?s FY 2018 Guidance-Priority Plan
      VC Deals Analysis: Could 2017 Smash $6bn Barrier?
      US FDA?s Gottlieb Takes Digital Device Questions From Senators At Cures Hearing 
      PubDate: Tue, 12 Dec 2017 16:50:19 GMT
       
  • Warning Letter Roundup & Recap
    • Abstract: US FDA did not release any device-related warning letters the week of Dec. 12      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Tue, 12 Dec 2017 16:27:29 GMT
       
  • LSP Scoops $330m For New Medtech Investment Fund
    • Abstract: Around 15 medtech companies will benefit from a new $330m fund that has just been raised by investment group LSP...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Tue, 12 Dec 2017 11:27:26 GMT
       
  • Edwards Adds To Wide Range Of Approaches To Mitral Repair
    • Abstract: Harpoon is a minimally invasive surgery device that complements Edwards pipeline of transcatheter mitral and septal valve repair and replacement...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Tue, 12 Dec 2017 08:30:18 GMT
       
  • Harpoon Finds Its Whale: Edwards Spends Up To $250m For Beating-Heart
           Mitral Repair Option
    • Abstract: Edwards Lifesciences exercised a 2015 option to buy Harpoon, a spin-off from the University of Maryland?s School of Medicine, for...      Related Stories
      UK Device Manufacturers Must Contingency Plan For A Hard Brexit
      New Path For 510(k)s On US FDA?s FY 2018 Guidance-Priority Plan
      VC Deals Analysis: Could 2017 Smash $6bn Barrier? 
      PubDate: Tue, 12 Dec 2017 08:23:32 GMT
       
  • QUOTED. Dec 12, 2017. Nathalie Moll.
    • Abstract: Check out what the European Federation of Pharmaceutical Industries and Associations? Nathalie Moll had to say about life-science industry alignment...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Tue, 12 Dec 2017 00:35:35 GMT
       
  • New Path For 510(k)s On US FDA's FY 2018 Guidance-Priority Plan
    • Abstract: FDA intends to draft a guidance by March outlining a voluntary, alternative 510(k) pathway for sponsors to demonstrate the substantial...      Related Stories
      UK Device Manufacturers Must Contingency Plan For A Hard Brexit
      VC Deals Analysis: Could 2017 Smash $6bn Barrier?
      US FDA?s Gottlieb Takes Digital Device Questions From Senators At Cures Hearing 
      PubDate: Mon, 11 Dec 2017 17:57:33 GMT
       
  • Start Up Spotlight: Thyncing Twice About Psoriasis
    • Abstract: Bioelectronics company Thync is gearing up for more clinical trials in 2018 to demonstrate the benefits of its neuromodulation platform...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Mon, 11 Dec 2017 13:24:31 GMT
       
  • VC Deals Analysis: Could 2017 Smash $6bn Barrier'
    • Abstract: November may have had the lowest deal volume of the year to date but five hefty fundraisings has pushed the...      Related Stories
      US FDA?s Gottlieb Takes Digital Device Questions From Senators At Cures Hearing
      MTI 100: Medtronic Still Leads, While M&A, Strategic Moves Elevate Others
      QUOTED. Dec. 8, 2017 
      PubDate: Mon, 11 Dec 2017 10:45:31 GMT
       
  • US Congress Passes Short-Term Funding, While Debt Ceiling Lingers
    • Abstract: Congress managed to temporarily stave off a government shutdown, but a continuing resolution bill passed Dec. 7 gives lawmakers only...      Related Stories
      First Expedited NGS Test Breaks Through FDA Review
      In Last Ditch Effort, Lawmakers Propose Five-Year Device Tax Moratorium
      QUOTED. Dec 13, 2017. Kyparissia Sirinakis. 
      PubDate: Mon, 11 Dec 2017 09:03:23 GMT
       
  • QUOTED. Dec. 11, 2017
    • Abstract: Check out what MedTech Innovator CEO Paul Grand had to say about why it?s important for his nonprofit group to...      Related Stories
      Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work
      Will Brexit Negotiations Move To Devices Soon?
      Planned US Device-Center Reorg Will Be Organized Around Device Types 
      PubDate: Mon, 11 Dec 2017 00:35:39 GMT
       
  • Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need
           Some Work
    • Abstract: US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline...      Related Stories
      Will Brexit Negotiations Move To Devices Soon?
      Planned US Device-Center Reorg Will Be Organized Around Device Types
      Stryker Expands ENT Breadth With $600m-Plus Deal 
      PubDate: Fri, 08 Dec 2017 17:10:00 GMT
       
  • US FDA's Gottlieb Takes Digital Device Questions From Senators At
           Cures Hearing
    • Abstract: The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development...      Related Stories
      MTI 100: Medtronic Still Leads, While M&A, Strategic Moves Elevate Others
      QUOTED. Dec. 8, 2017
      Starts & Stops: Mercator Finishes Enrollment In Critical Limb Ischemia Trial; Looks Forward To New Indications For Micro-Infusion Drug-Delivery 
      PubDate: Fri, 08 Dec 2017 15:59:43 GMT
       
  • MTI 100: Medtronic Still Leads, While M&A, Strategic Moves Elevate
           Others
    • Abstract: After knocking Johnson & Johnson off its long-held top position last year, Medtronic has successfully retained the lead in the...      Related Stories
      US FDA?s Gottlieb Takes Digital Device Questions From Senators At Cures Hearing
      MTI 100: Medtronic Still Leads, While M&A, Strategic Moves Elevate Others
      QUOTED. Dec. 8, 2017 
      PubDate: Fri, 08 Dec 2017 15:00:31 GMT
       
  • Will Brexit Negotiations Move To Devices Soon'
    • Abstract: It?s been a long and painful journey, but some progress has finally been made in Brexit talks. It is looking...      Related Stories
      Will Brexit Negotiations Move To Devices Soon?
      Planned US Device-Center Reorg Will Be Organized Around Device Types
      Stryker Expands ENT Breadth With $600m-Plus Deal 
      PubDate: Fri, 08 Dec 2017 14:44:22 GMT
       
  • Planned US Device-Center Reorg Will Be Organized Around Device Types
    • Abstract: CDRH compliance official Sean Boyd described agency plans to group staff in device-specific offices that would handle products from pre-market...      Related Stories
      Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work
      Will Brexit Negotiations Move To Devices Soon?
      Stryker Expands ENT Breadth With $600m-Plus Deal 
      PubDate: Fri, 08 Dec 2017 11:40:40 GMT
       
 
 
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