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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]
  • Number To Know…275
    • Abstract: 275 is the number of recalls initiated by medical device manufacturers in the second quarter of 2017. That?s a 3%...      Related Stories
      Senator Introduces Medical Device Cybersecurity Act
      US FDA Warns of Deaths Tied To Gastric Balloons
      Number To Know…18 
      PubDate: Mon, 14 Aug 2017 03:00:53 GMT
       
  • Senator Introduces Medical Device Cybersecurity Act
    • Abstract: Sen. Richard Blumenthal, D-Conn., recently introduced legislation that would enhance medical device security by generating a "cyber report card" for...      Related Stories
      US FDA Warns of Deaths Tied To Gastric Balloons
      Number To Know…18
      Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR 
      PubDate: Fri, 11 Aug 2017 18:06:10 GMT
       
  • US FDA Warns of Deaths Tied To Gastric Balloons
    • Abstract: The agency doesn’t yet know the exact causes of the five deaths. This is the second safety alert on the...      Related Stories
      Number To Know…18
      Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR
      Abbott Launches Feasibility Trial Of Tricuspid Version Of MitraClip 
      PubDate: Fri, 11 Aug 2017 16:13:06 GMT
       
  • Quality Replay: Device History Record ‘Oversights’ A Clear Path To
           Quality Troubles, FDA Says
    • Abstract: From our digital archives: Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date...      Related Stories
      Pelvic Mesh Cases Continue As Endo Moves To Settle
      US House ?Problem Solvers,? AdvaMed, Aim To Repeal Device Tax
      Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly 
      PubDate: Fri, 11 Aug 2017 13:24:49 GMT
       
  • Over 170 Provisional Draft Codes Published For Notified Body Designation
           Under MDR & IVDR
    • Abstract: Three new draft documents relating to notified bodies list the codes being prepared to determine their scope of responsibility for...      Related Stories
      Senator Introduces Medical Device Cybersecurity Act
      US FDA Warns of Deaths Tied To Gastric Balloons
      Number To Know…18 
      PubDate: Fri, 11 Aug 2017 12:42:08 GMT
       
  • Pelvic Mesh Cases Continue As Endo Moves To Settle
    • Abstract: Endo International announced plans this week to pay $775m to settle 22,000 US claims. Meanwhile, J&J is launching its sixth...      Related Stories
      Pelvic Mesh Cases Continue As Endo Moves To Settle
      US House ?Problem Solvers,? AdvaMed, Aim To Repeal Device Tax
      Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly 
      PubDate: Fri, 11 Aug 2017 11:01:27 GMT
       
  • Number To Know…18
    • Abstract: There are 18 Austrian insurance funds that will reimburse Novocure?s Optune device for treating adult patients with newly diagnosed glioblastoma...      Related Stories
      Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR
      Abbott Launches Feasibility Trial Of Tricuspid Version Of MitraClip
      ?It?s Time?: AdvaMed Device Tax Ad Campaign Sets Sights On Key Lawmakers 
      PubDate: Fri, 11 Aug 2017 00:04:36 GMT
       
  • US House 'Problem Solvers,' AdvaMed, Aim To Repeal Device
           Tax
    • Abstract: Two recent efforts to repeal the medical device tax include proposed legislation by a bipartisan "Problem Solvers" group of House...      Related Stories
      Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly
      Medicare Proposal To Cover Outpatient Knee, Hip Procedures Raises Patient Selection, Bundling Questions
      US Approvals Analysis: Drug-Coated Balloon, Valve Tech Are July Highlights 
      PubDate: Thu, 10 Aug 2017 19:15:37 GMT
       
  • Abbott Launches Feasibility Trial Of Tricuspid Version Of MitraClip
    • Abstract: The TRILUMINATE trial will evaluate safety and effectiveness of its Tricuspid Valve Repair System for treating symptomatic moderate-to-severe tricuspid regurgitation...      Related Stories
      Senator Introduces Medical Device Cybersecurity Act
      US FDA Warns of Deaths Tied To Gastric Balloons
      Number To Know…18 
      PubDate: Thu, 10 Aug 2017 18:53:04 GMT
       
  • 'It's Time': AdvaMed Device Tax Ad Campaign Sets
           Sights On Key Lawmakers
    • Abstract: While lawmakers are back in their districts during Congress? recess, AdvaMed is running local ads aimed at major congressional leaders...      Related Stories
      Senator Introduces Medical Device Cybersecurity Act
      US FDA Warns of Deaths Tied To Gastric Balloons
      Number To Know…18 
      PubDate: Thu, 10 Aug 2017 18:28:39 GMT
       
  • US FDA Planning For Possible Doubling Of HQ-Based Staff In 15 Years
    • Abstract: A federal facilities agency will gauge impact of FDA staffing increase to about 18,000 at its White Oak campus.      Related Stories
      Senator Introduces Medical Device Cybersecurity Act
      US FDA Warns of Deaths Tied To Gastric Balloons
      Number To Know…18 
      PubDate: Thu, 10 Aug 2017 17:29:07 GMT
       
  • Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls
           Dip Slightly
    • Abstract: The number of high-risk class I recalls ballooned 88% in the second quarter of 2017. Overall, recalls fell 3%. Check...      Related Stories
      Medicare Proposal To Cover Outpatient Knee, Hip Procedures Raises Patient Selection, Bundling Questions
      US Approvals Analysis: Drug-Coated Balloon, Valve Tech Are July Highlights
      Earnings Winners & Losers, Medtech ?Pure-Plays? BSX, ISRG, BDX, VAR, RMD, 
      PubDate: Thu, 10 Aug 2017 11:59:19 GMT
       
  • Number To Know…9m
    • Abstract: $9m is the amount Israeli neurovavscular technology company Rapid Medical raised in series B financing in July. The firm is...      Related Stories
      Start Up Spotlight: Rapid Medical, A New Era Of Neurovascular Devices
      Number To Know…10.4m
      Consent Requirement Change Could Be Boon For Minimal-Risk Studies 
      PubDate: Thu, 10 Aug 2017 10:39:21 GMT
       
  • Start Up Spotlight: Rapid Medical, A New Era Of Neurovascular Devices
    • Abstract: Israeli company Rapid Medical has developed two controllable neurovascular interventional devices for stroke treatment, the Comaneci mesh device for aneurysm...      Related Stories
      Number To Know…10.4m
      Consent Requirement Change Could Be Boon For Minimal-Risk Studies
      Philips Awarded $10.4m in Electrode Patent Spat 
      PubDate: Thu, 10 Aug 2017 06:11:32 GMT
       
  • Medicare Proposal To Cover Outpatient Knee, Hip Procedures Raises Patient
           Selection, Bundling Questions
    • Abstract: Improvements in technology surrounding knee and hip replacements means a shorter recovery time for patients, but a recent US CMS...      Related Stories
      Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly
      Medicare Proposal To Cover Outpatient Knee, Hip Procedures Raises Patient Selection, Bundling Questions
      US Approvals Analysis: Drug-Coated Balloon, Valve Tech Are July Highlights 
      PubDate: Wed, 09 Aug 2017 17:36:55 GMT
       
  • AUDIO: Device Week – Global Regulations Update, Aug. 9, 2017
    • Abstract: Want to know more about medtech regulatory efforts in countries from Singapore to Myanmar to Russia, and more in between...      Related Stories
      Abbott’s Devare On Keeping Pace With Viruses And Effective Testing
      AUDIO: Podcast: Game Changer For Digital Health? A Talk With FDA?s Bakul Patel
      AUDIO: Podcast: Game Changer For Digital Health? A Talk With Bakul Patel 
      PubDate: Wed, 09 Aug 2017 16:37:36 GMT
       
  • US Approvals Analysis: Drug-Coated Balloon, Valve Tech Are July Highlights
    • Abstract: July was a relatively light month for novel-device approvals by US FDA, but year-to-date volumes remain strong. Spotlighted devices include...      Related Stories
      Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly
      Medicare Proposal To Cover Outpatient Knee, Hip Procedures Raises Patient Selection, Bundling Questions
      Earnings Winners & Losers, Medtech ?Pure-Plays? BSX, ISRG, BDX, VAR, RMD, 
      PubDate: Wed, 09 Aug 2017 14:25:22 GMT
       
  • Number To Know…10.4m
    • Abstract: $10.4m is how much a jury has ordered Zoll Medical to pay Philips in a long-running patent infringement spat between...      Related Stories
      Consent Requirement Change Could Be Boon For Minimal-Risk Studies
      Philips Awarded $10.4m in Electrode Patent Spat
      Hiring Plans Are Central To US FDA?s Digital Health Plan 
      PubDate: Wed, 09 Aug 2017 10:16:44 GMT
       
  • Consent Requirement Change Could Be Boon For Minimal-Risk Studies
    • Abstract: US FDA has issued a temporary guidance to allow researchers to conduct "minimal-risk" clinical studies without consent and harmonize the...      Related Stories
      Number To Know…9m
      Start Up Spotlight: Rapid Medical, A New Era Of Neurovascular Devices
      Number To Know…10.4m 
      PubDate: Tue, 08 Aug 2017 17:47:09 GMT
       
  • Philips Awarded $10.4m in Electrode Patent Spat
    • Abstract: The award comes in the penalty phase of a long-running lawsuit over automatic external defibrillators; Philips had initially demanded $217m...      Related Stories
      Number To Know…10.4m
      Consent Requirement Change Could Be Boon For Minimal-Risk Studies
      Hiring Plans Are Central To US FDA?s Digital Health Plan 
      PubDate: Tue, 08 Aug 2017 17:45:21 GMT
       
 
 
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