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Journal Cover Medtech Insight
  [2 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 1876-8008
   Published by Informa plc Homepage  [9 journals]
  • Patients Want Industry To Minimize Burdens, Augment Comforts Of Device
           Trial Participation
    • Abstract: Patients and patient advocacy groups at the US FDA?s inaugural Patient Engagement Advisory Committee meeting said they need sponsors to...      Related Stories
      New Connected-Health Standards Signal US FDA?s Future Thinking
      Hannon Officially Takes The Helm At Mainstay Medical
      Canada Prepares To Publish Draft Rules On Release Of Clinical Data 
      PubDate: Fri, 13 Oct 2017 17:35:03 GMT
       
  • Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation
    • Abstract: Regardless of the path that the UK-EU Brexit negotiations take, the UK MHRA and the bulk of the local medtech...      Related Stories
      Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer
      OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India
      UK IVD Industry Finds New Voice And Appetite For Challenges Ahead 
      PubDate: Fri, 13 Oct 2017 17:27:30 GMT
       
  • New Connected-Health Standards Signal US FDA's Future Thinking
    • Abstract: Standards organizations say software and informatics standards recently recognized by US FDA are a sign of the technologies the agency...      Related Stories
      Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation
      New Connected-Health Standards Signal US FDA?s Future Thinking
      Hannon Officially Takes The Helm At Mainstay Medical 
      PubDate: Fri, 13 Oct 2017 14:58:09 GMT
       
  • Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer
    • Abstract: Having secured Medicare reimbursement, Seattle, Washington-based Indi Diagnostics, Inc. is getting ready to bring its liquid biopsy molecular test to...      Related Stories
      Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation
      OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India
      UK IVD Industry Finds New Voice And Appetite For Challenges Ahead 
      PubDate: Fri, 13 Oct 2017 13:10:56 GMT
       
  • Hannon Officially Takes The Helm At Mainstay Medical
    • Abstract: Jason Hannon, former president and COO of spinal device manufacturer NuVasive Inc., has officially assumed the role of CEO and...      Related Stories
      Canada Prepares To Publish Draft Rules On Release Of Clinical Data
      Medtech Fees To Soar in Canada Under Government Proposals
      Will AAA?s Nuclear Med Offerings Turn M&A Buzz Into A Deal? 
      PubDate: Fri, 13 Oct 2017 11:33:07 GMT
       
  • Medtech Fees To Soar In Canada Under Government Proposals
    • Abstract: The licence evaluation fee Health Canada charges for Class IV medical devices could jump from CAN$12,347-$22,560 to $30,063 under proposals...      Related Stories
      Will AAA?s Nuclear Med Offerings Turn M&A Buzz Into A Deal?
      OBD?s Epigenetic Biomarker Tech Shows Ethnicity Issue-Free Dx Potential
      Philips? Profit To Be Dented By FDA-Decreed AED Sales Halt 
      PubDate: Fri, 13 Oct 2017 11:20:35 GMT
       
  • Canada Prepares To Publish Draft Rules On Release Of Clinical Data
    • Abstract: Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the...      Related Stories
      New Connected-Health Standards Signal US FDA?s Future Thinking
      Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation
      Hannon Officially Takes The Helm At Mainstay Medical 
      PubDate: Fri, 13 Oct 2017 11:20:32 GMT
       
  • OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks;
           iVascular Earns Five Approvals In India
    • Abstract: Cardiovascular and diabetes device dominated September?s list of medical device approvals from outside the US on Medtech Insight?s Approvals Tracker...      Related Stories
      Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation
      Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer
      UK IVD Industry Finds New Voice And Appetite For Challenges Ahead 
      PubDate: Fri, 13 Oct 2017 09:25:37 GMT
       
  • UK IVD Industry Finds New Voice And Appetite For Challenges Ahead
    • Abstract: The association of the IVD industry in the UK, BIVDA, is undergoing a rebrand and proactively positioning itself to reinforce...      Related Stories
      Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation
      Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer
      OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India 
      PubDate: Thu, 12 Oct 2017 17:58:28 GMT
       
  • US Approvals Analysis: Cook Churns Out 510(k)s In Q3
    • Abstract: The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the...      Related Stories
      Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation
      Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer
      OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India 
      PubDate: Thu, 12 Oct 2017 17:21:00 GMT
       
  • Three-Year EU MDR Transition Period' More Like 12-18 Months
    • Abstract: So, you think you have nearly three years to comply with the EU?s Medical Device Regulation and five years with...      Related Stories
      AUDIO: Device Week, Oct. 12, 2017 – Tomorrow?s Technologies At The Medtech Conference; M&A Keeps A-Pace
      Start-Up Spotlight: Arkis BioSciences Launched Innovative External Ventricular Drainage Catheter, Reduces Catheter Obstructions
      UK NICE’s MedTech Scan Will Give NHS Early View Of Innovation 
      PubDate: Thu, 12 Oct 2017 17:10:16 GMT
       
  • Will AAA's Nuclear Med Offerings Turn M&A Buzz Into A
           Deal'
    • Abstract: Advanced Accelerator Applications (AAA) has hit the headlines with recent rumors of a potential acquisition deal from Novartis. Now that...      Related Stories
      New Connected-Health Standards Signal US FDA?s Future Thinking
      Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation
      Hannon Officially Takes The Helm At Mainstay Medical 
      PubDate: Thu, 12 Oct 2017 14:46:05 GMT
       
  • OBD's Epigenetic Biomarker Tech Shows Ethnicity Issue-Free Dx
           Potential
    • Abstract: Recent studies completed by epigenetic biomarker company Oxford BioDynamics have shown the company?s platform technology EpiSwitch can diagnose and stage...      Related Stories
      New Connected-Health Standards Signal US FDA?s Future Thinking
      Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation
      Hannon Officially Takes The Helm At Mainstay Medical 
      PubDate: Thu, 12 Oct 2017 12:55:46 GMT
       
  • AUDIO: Device Week, Oct. 12, 2017 – Tomorrow's Technologies At The
           Medtech Conference; M&A Keeps A-Pace
    • Abstract: In this edition of Device Week, find out which were the most interesting startups showcased at AdvaMed’s annual Medtech Conference...      Related Stories
      Start-Up Spotlight: Arkis BioSciences Launched Innovative External Ventricular Drainage Catheter, Reduces Catheter Obstructions
      UK NICE’s MedTech Scan Will Give NHS Early View Of Innovation
      Trump Rollback Of ACA Birth-Control Coverage Mandate To Push Down Gains In IUD Sales 
      PubDate: Thu, 12 Oct 2017 07:05:18 GMT
       
  • Start-Up Spotlight: Arkis BioSciences, Endexo-Boosted Ventricular Drainage
           Catheter Reduces Obstructions
    • Abstract: Arkis BioSciences Inc.?s newly launched CerebroFlo EVD catheter for treating intracranial hypertension offers an added benefit of being impregnated with...      Related Stories
      UK NICE’s MedTech Scan Will Give NHS Early View Of Innovation
      Trump Rollback Of ACA Birth-Control Coverage Mandate To Push Down Gains In IUD Sales
      Contradictory Messages Over Medtech and Brexit: MDR? No MDR? 
      PubDate: Wed, 11 Oct 2017 19:00:08 GMT
       
  • Trump Rollback Of ACA Birth-Control Coverage Mandate To Push Down Gains In
           IUD Sales
    • Abstract: More religious-based college employers, and for-profit businesses with moral objections to contraceptive coverage, will be able to issue health plans...      Related Stories
      AUDIO: Device Week, Oct. 12, 2017 – Tomorrow?s Technologies At The Medtech Conference; M&A Keeps A-Pace
      Start-Up Spotlight: Arkis BioSciences Launched Innovative External Ventricular Drainage Catheter, Reduces Catheter Obstructions
      UK NICE’s MedTech Scan Will Give NHS Early View Of Innovation 
      PubDate: Wed, 11 Oct 2017 16:49:22 GMT
       
  • Global Medtech Guidance Tracker: September 2017
    • Abstract: Stay current on regulatory guidelines from around the world with Medtech Insight?s Guidance Tracker. Twenty-eight new guidance documents were posted...      Related Stories
      MDUFA IV Makeover For US FDA Guidances
      Global Medtech Guidance Tracker: August 2017
      US Regulatory Reads, August 2017: MDUFA IV; Risk-Benefit; Gastric-Balloon Warning 
      PubDate: Wed, 11 Oct 2017 16:43:51 GMT
       
  • UK NICE’s MedTech Scan Will Give NHS Early View Of Innovation
    • Abstract: The UK National Institute for Health and Care Excellence is working on a new database of pre-launch-phase medtech products. The...      Related Stories
      AUDIO: Device Week, Oct. 12, 2017 – Tomorrow?s Technologies At The Medtech Conference; M&A Keeps A-Pace
      Start-Up Spotlight: Arkis BioSciences Launched Innovative External Ventricular Drainage Catheter, Reduces Catheter Obstructions
      Trump Rollback Of ACA Birth-Control Coverage Mandate To Push Down Gains In IUD Sales 
      PubDate: Wed, 11 Oct 2017 16:09:25 GMT
       
  • Philips' Profit To Be Dented By FDA-Decreed AED Sales Halt
    • Abstract: On signing a consent decree with the US FDA, Philips is halting manufacture and sales of external defibrillators produced at...      Related Stories
      MDxHealth Gears Up For Major EU Growth
      Augmenix Looks To Apply Hydrogel Technology Beyond Prostate Cancer
      Warning Letter Roundup & Recap – Oct. 10, 2017 
      PubDate: Wed, 11 Oct 2017 11:45:29 GMT
       
  • MDxHealth Gears Up For Major EU Growth
    • Abstract: Cancer diagnostics company MDxHealth is poised for more commercial growth in 2018 following a move to larger lab facilities in...      Related Stories
      Philips? Profit To Be Dented By FDA-Decreed AED Sales Halt
      Augmenix Looks To Apply Hydrogel Technology Beyond Prostate Cancer
      Warning Letter Roundup & Recap – Oct. 10, 2017 
      PubDate: Wed, 11 Oct 2017 10:40:47 GMT
       
 
 
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