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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]
  • Number To Know…1,500
    • Abstract: Anova Cancer Care Center in Colorado this month treated its 1,500th prostate cancer patient with the robotic radiation therapy device...      Related Stories
      China Proposes Local Trial Exemptions For Another 130 IVDs, 27 Devices
      Q&A: FDA Dx Reviewer?s Tips For Next-Gen Sequencing Sponsors
      Philips Completes M&A Hat Trick With Neurodiagnostic Buy 
      PubDate: Fri, 23 Jun 2017 11:17:04 GMT
       
  • China Proposes Local Trial Exemptions For Another 130 IVDs, 27 Devices
    • Abstract: China has proposed expanding its list of IVDs and medical devices that are exempted from the requirement to undergo local...      Related Stories
      Number To Know…1,500
      Q&A: FDA Dx Reviewer?s Tips For Next-Gen Sequencing Sponsors
      Philips Completes M&A Hat Trick With Neurodiagnostic Buy 
      PubDate: Fri, 23 Jun 2017 10:53:01 GMT
       
  • Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing
           Sponsors
    • Abstract: A top reviewer in US FDA?s in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common...      Related Stories
      Number To Know…1,500
      China Proposes Local Trial Exemptions For Another 130 IVDs, 27 Devices
      Q&A: FDA Dx Reviewer?s Tips For Next-Gen Sequencing Sponsors 
      PubDate: Thu, 22 Jun 2017 15:40:35 GMT
       
  • Virtual Reality: The New Game In Mental Health Care To Improve Outcomes
    • Abstract: Virtual reality is seeing an upsurge in use by mental health practitioners for treating conditions such as post-traumatic stress disorder...      Related Stories
      Compliance Corner: Keep ?ALCOA? In Mind To Ensure Quality Data Integrity, Says US FDA Expert
      South African Medtech Reg: Pieces Coming Together, As August Deadline Approaches 
      PubDate: Thu, 22 Jun 2017 12:56:12 GMT
       
  • Philips Completes M&A Hat Trick With Neurodiagnostic Buy
    • Abstract: In its third acquisition this year so far, Philips is buying neurodiagnostic firm Electrical Geodesics.      Related Stories
      Number To Know…1,500
      China Proposes Local Trial Exemptions For Another 130 IVDs, 27 Devices
      Q&A: FDA Dx Reviewer?s Tips For Next-Gen Sequencing Sponsors 
      PubDate: Thu, 22 Jun 2017 12:00:54 GMT
       
  • Number To Know…29
    • Abstract: SEK29 was the final price at which Bonesupport?s shares were set in the Swedish company?s initial public offering on the...      Related Stories
      Bonesupport Cements Funding With SEK 500m IPO
      US Trade Rep May Take Enforcement Actions Against India Over Device Price Controls
      Warning Letter Roundup & Recap – June 20, 2017 
      PubDate: Thu, 22 Jun 2017 10:11:39 GMT
       
  • Bonesupport Cements Funding With SEK 500m IPO
    • Abstract: Swedish orthobiologics company Bonesupport has closed its initial public offering on the Nasdaq Stockholm exchange, raising SEK500m ($57m) from retail...      Related Stories
      US Trade Rep May Take Enforcement Actions Against India Over Device Price Controls
      Warning Letter Roundup & Recap – June 20, 2017
      Number To Know…11.75 
      PubDate: Thu, 22 Jun 2017 09:08:58 GMT
       
  • Compliance Corner: Keep 'ALCOA' In Mind To Ensure Quality Data
           Integrity, Says US FDA Expert
    • Abstract: When inspecting a device manufacturing facility, FDA investigators will check a company?s quality data to make sure it?s Attributable, Legible...      Related Stories
      Virtual Reality: The New Game In Mental Health Care To Improve Outcomes
      Compliance Corner: Keep ?ALCOA? In Mind To Ensure Quality Data Integrity, Says US FDA Expert
      South African Medtech Reg: Pieces Coming Together, As August Deadline Approaches 
      PubDate: Thu, 22 Jun 2017 09:01:00 GMT
       
  • US Trade Rep May Take Enforcement Actions Against India Over Device Price
           Controls
    • Abstract: US Trade Representative Robert Lighthizer told Senate Finance Committee Chairman Orrin Hatch, R-Utah, that if India?s ongoing practices to impose...      Related Stories
      Number To Know…1,500
      China Proposes Local Trial Exemptions For Another 130 IVDs, 27 Devices
      Q&A: FDA Dx Reviewer?s Tips For Next-Gen Sequencing Sponsors 
      PubDate: Wed, 21 Jun 2017 18:15:01 GMT
       
  • Warning Letter Roundup & Recap – June 20, 2017
    • Abstract: US FDA did not release any device-related warning letters the week of June 20.      Related Stories
      Number To Know…11.75
      US FDA Updates Clinical Trial E-Reporting, E-Signature Guidance To Keep Up With Tech
      Stryker Doubles Down On Novadaq To Boost Medsurg 
      PubDate: Wed, 21 Jun 2017 17:02:38 GMT
       
  • South African Medtech Reg: Pieces Coming Together, As August Deadline
           Approaches
    • Abstract: South African medtech firms have been given until August 24 to license their business establishments and list (but not actually...      Related Stories
      Virtual Reality: The New Game In Mental Health Care To Improve Outcomes
      Compliance Corner: Keep ?ALCOA? In Mind To Ensure Quality Data Integrity, Says US FDA Expert
      South African Medtech Reg: Pieces Coming Together, As August Deadline Approaches 
      PubDate: Wed, 21 Jun 2017 14:24:23 GMT
       
  • AUDIO: UK Medtech Upscales International Plans Ahead of Brexit
    • Abstract: As the UK prepared to leave the EU, the local medtech industry, represented by the Association of British Healthcare Industries...       
      PubDate: Wed, 21 Jun 2017 13:02:04 GMT
       
  • Number To Know…11.75
    • Abstract: Stryker has agreed to pay $11.75 per share in cash to acquire Canadian imaging technology firm Novadaq. The purchase price...      Related Stories
      US FDA Updates Clinical Trial E-Reporting, E-Signature Guidance To Keep Up With Tech
      Stryker Doubles Down On Novadaq To Boost Medsurg
      Former ArthroCare CFO Pleads Guilty to Fraud 
      PubDate: Wed, 21 Jun 2017 09:49:28 GMT
       
  • US FDA Updates Clinical Trial E-Reporting, E-Signature Guidance To Keep Up
           With Tech
    • Abstract: In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product...      Related Stories
      Number To Know…11.75
      Stryker Doubles Down On Novadaq To Boost Medsurg
      Former ArthroCare CFO Pleads Guilty to Fraud 
      PubDate: Wed, 21 Jun 2017 09:42:26 GMT
       
  • Device Lobbyists Support Device Tax Repeal in Senate Health Bill, As
           Providers Remain Opposed
    • Abstract: AdvaMed members ratcheted up pressure on members of Congress last week to permanently abolish the device tax, be it in...      Related Stories
      Starts & Stops: Corlife?s Decellularized Human Pulmonary Valve Shows Early Promise
      Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says
      Medtech Summit: The Three Biggest Challenges Of The EU MDR 
      PubDate: Tue, 20 Jun 2017 18:02:00 GMT
       
  • Medtech Summit: The Three Biggest Challenges Of The EU MDR
    • Abstract: The EU?s Medical Devices Regulation has entered into force, but there is still three years until it is fully applicable...      Related Stories
      Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says
      South Africa Medtech Reg: As New System Nears Finish Line, Device-Drug Distinctions Still Need Highlighting
      OUS Approvals Analysis: IVDs Lead A Slow Month 
      PubDate: Tue, 20 Jun 2017 17:56:24 GMT
       
  • Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To
           Consumers, Agency Expert Says
    • Abstract: Manufacturers that don?t consider all possible dangers their products can pose to consumers is a growing problem, FDA?s national expert...      Related Stories
      Starts & Stops: Corlife?s Decellularized Human Pulmonary Valve Shows Early Promise
      Device Lobbyists Support Device Tax Repeal in Senate Health Bill, As Providers Remain Opposed
      Medtech Summit: The Three Biggest Challenges Of The EU MDR 
      PubDate: Tue, 20 Jun 2017 17:24:24 GMT
       
  • South Africa Medtech Reg: As New System Nears Finish Line, Device-Drug
           Distinctions Still Need Highlighting
    • Abstract: Stakeholders pushing for a dedicated medtech regulatory system in South Africa have been in sight of the finish line on...      Related Stories
      Starts & Stops: Corlife?s Decellularized Human Pulmonary Valve Shows Early Promise
      Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says
      Device Lobbyists Support Device Tax Repeal in Senate Health Bill, As Providers Remain Opposed 
      PubDate: Tue, 20 Jun 2017 16:01:35 GMT
       
  • 21st Century Cures Implementation: Device Provision Updates
    • Abstract: Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act...      Related Stories
      21st Century Cures Implementation: Device Provision Updates 
      PubDate: Tue, 20 Jun 2017 13:42:47 GMT
       
  • Number To Know…40
    • Abstract: 40% is the approximately how much IVD-related sales will contribute to PerkinElmer?s total revenue once the company completes its $1.3bn...      Related Stories
      Stryker Doubles Down On Novadaq To Boost Medsurg
      Positive Data Give DePuy Synthes? Attune Further Knee-Up
      Australia’s TGA Overrides Industry Concerns Over Publishing Priority-Review Pathway Decisions 
      PubDate: Tue, 20 Jun 2017 12:18:04 GMT
       
 
 
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