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  The Gray Sheet
   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1214
   Published by Informa plc Homepage  [14 journals]
  • Capitol Hill News In Brief
    • Abstract: Senate passage sends trade promotion authority bill to President Obama for his signature; House “21st Century Cures” legislation gains 230 co-sponsors in the House; Senate Finance panel marks up disposable medical technologies bill.
      PubDate: Mon, 29 Jun 2015 00:00:47 -040
  • Device Week Podcast – Episode 4
    • Abstract: This week, "Gray Sheet" reporters and editors discuss combination product reforms, a draft guidance on unique device identification direct marking, device money on Capitol Hill, a study on how many older patients are getting primary prevention ICDs and our interview with CDRH's interim compliance chief.
      PubDate: Mon, 29 Jun 2015 00:00:00 -040
  • Former OtisMed CEO Sentenced To Two Years For Selling FDA-Rejected Knee
    • Abstract: The sentencing, which also includes an additional one year of supervised release and a $75,000 fine, concludes a long-running investigation into the firm, which is now a subsidiary of Stryker.
      PubDate: Fri, 26 Jun 2015 18:05:01 -040
  • Only 8 Percent Of Older ICD-Eligible Heart Failure Patients Get An ICD,
           Study Finds
    • Abstract: Improved patient follow up and communications may be needed to get implantable defibrillators to more patients who need them, researchers say following a recent study finding fewer than 10 percent of eligible patients with low ejection fraction received an ICD within a year after a heart attack, even though ICD implants were associated with lower risk-adjusted two-year mortality in this group.
      PubDate: Fri, 26 Jun 2015 18:00:00 -040
  • Direct-Marking UDI Draft Lays Out Tips, Timelines For Reprocessed Devices
    • Abstract: The agency issued draft guidance document on direct marking requirements for unique device identifiers, seeking guidance on the definition of "reprocessing" and laying out timelines.
      PubDate: Thu, 25 Jun 2015 17:30:00 -040
  • FDA Plans Panel Review For Essure Birth Control In
           Response To Patient Complaints
    • Abstract: The agency says it has met with patients and patient advocates about complaints, device removal challenges and other issues with Bayer's Essure female sterilization system, leading to an FDA review of safety reports and a panel date scheduled for September.
      PubDate: Thu, 25 Jun 2015 16:30:00 -040
  • Zimmer, Biomet Sell Off Some U.S. Assets As They Finalize A $14 Bil.
    • Abstract: Zimmer Biomet is now the second-largest orthopedic device maker behind Johnson & Johnson now that the merger between the two firms is complete. The companies divested some U.S. knee, elbow and bone cement assets in conjunction with finalized the deal after having sold of some European assets earlier in the year.
      PubDate: Thu, 25 Jun 2015 15:45:02 -040
  • LivaNova Set To Launch In Q3 With Sorin-Cyberonics Combination
    • Abstract: Sorin and Cyberonics announced the name of their combined company, expected to be formed by the end of the third quarter.
      PubDate: Thu, 25 Jun 2015 15:00:02 -040
  • Podcast: BioMerieux CEO On Addressing Antibiotic Resistance With
    • Abstract: Earlier this month, the White House hosted a forum on antibiotic stewardship to advance President Obama's national action plan to combat antibiotic resistance. The diagnostics firm bioMerieux participated in the forum and its CEO Stefan Willemsen recently sat down with "The Gray Sheet" to discuss the issue.
      PubDate: Wed, 24 Jun 2015 18:05:02 -040
  • CBO Sets $158 Million Price Tag For Breakthrough Devices In Cures Bill
    • Abstract: The Congressional Budget Office estimates that the cost of all FDA device provisions, including a breakthrough device pathway, in the House 21st Century Cures bill would be $299 million, a significant chunk of the total costs for FDA provisions in the bill.
      PubDate: Wed, 24 Jun 2015 18:00:00 -040
  • Combo Product Reforms Are A Priority For Next User Fee Round, FDA
           Officials Say
    • Abstract: Top FDA officials, including CDRH Director Jeffrey Shuren and FDA Deputy Commissioner Robert Califf, are sending strong signals that the designation and review processes for combination products are due for a significant reassessment. That should be a priority topic of upcoming user fee negotiations with industry, they say.
      PubDate: Wed, 24 Jun 2015 16:25:00 -040
  • No Precision Medicine Dollars For FDA Molecular Dx Development In House
    • Abstract: The House Appropriations Committee subpanel does not include any more for the FDA's portion of President Obama’s Precision Medicine Initiative to help modernize the regulatory framework for molecular diagnostics in its proposed 2016 funding measure, and would reduce the CDRH budget.
      PubDate: Tue, 23 Jun 2015 18:15:01 -040
  • FDA Relies On Short-Term Data To Approve Medtronic's Recapturable TAVR
    • Abstract: The approval comes less than a week after FDA approved Edwards' Sapien 3 third-generation transcatheter aortic replacement valve. Both devices were approved based on short-term outcomes data instead of the two-year data FDA has required of TAVR systems in the past.
      PubDate: Tue, 23 Jun 2015 17:40:01 -040
  • Guest Column: Getting The IEC 60601-1 Standard Right In The U.S. And
    • Abstract: The IEC 60601-1 standard on medical electric equipment is a critical tool for many medical technology companies. In this article, device consultant Leo Eisner introduces the standard and shares how it is being used in the U.S. and Canada.
      PubDate: Tue, 23 Jun 2015 17:00:01 -040
  • Warning Letter Roundup & Recap – June 23, 2015
    • Abstract: AG Industries didn't complete an MDR review and file an MDR with FDA when one of its mini-nebulizers shocked a child; and more. The letter to that company was the only device warning letter listed by FDA this week.
      PubDate: Tue, 23 Jun 2015 16:25:01 -040
  • Medtronic Touts AdaptivCRT Algorithm Economic
           Benefits With New Heart Failure Data
    • Abstract: Results of ADAPTIVE CRT trial show that resynchronization therapy devices with Medtronic's AdaptivCRT algorithm reduce heart failure hospitalizations.
      PubDate: Tue, 23 Jun 2015 11:45:00 -040
  • Malaysia Consults On Medtech Reg Conformity, Refurbished Devices
    • Abstract: The Malaysian Medical Device Authority is inviting feedback on two draft guidelines, the first explaining the requirements for declaring conformity with medtech regulations and the second dealing with good practices for refurbishment of used medical devices.
      PubDate: Mon, 22 Jun 2015 18:00:01 -040
  • People Briefs: Hologic, Cook Group, AxoGen, Rivanna
    • Abstract: Hologic announces board changes; Cook Group names new president; AxoGen chief marketing officer resigns; Rivanna Medical appoints clinical advisor.
      PubDate: Mon, 22 Jun 2015 17:50:01 -040
  • Device Week Podcast – Episode 3
    • Abstract: This week, "Gray Sheet" reporters and editors discuss our exclusive interview with FDA's Robert Califf and the agency's ongoing efforts to reform combination product regulations, Medicare reimbursements for molecular diagnostic tests, efforts to repeal the medical device tax, earlier than anticipated approval of Edwards Lifesciences' latest transcatheter aortic valve system and more.
      PubDate: Mon, 22 Jun 2015 00:03:00 -040
  • EU Device Reform Progresses With Council Amendments
    • Abstract: The Council of the European Union reached agreement on amendments to European regulatory reforms for devices and diagnostics, setting the stage for a trialogue with the Parliament and Commission beginning this fall.
      PubDate: Mon, 22 Jun 2015 00:02:40 -040
  • Senate Bill Tackles 'Least Burdensome,' Centralized IRBs, CLIA Waivers
    • Abstract: The targeted FDA Device Accountability Act mirrors select device sections of the House 21st Century Cures legislation seeking to strengthen the use of "least-burdensome" provisions, allow use of centralized IRBs for device trials and refining standards for diagnostic CLIA waivers.
      PubDate: Thu, 18 Jun 2015 17:25:06 -040
  • House Votes To Repeal Device Tax, Again
    • Abstract: Congressional leaders have again voted to repeal the 2.3 percent medical device tax criticized by industry for stifling innovation and jobs, and sent it to the Senate for approval. Concerns still surround whether the bill is approvable without an offset.
      PubDate: Thu, 18 Jun 2015 17:25:01 -040
  • Roche's Oncology Drug Strategy Emphasizes Comprehensive Diagnostics
    • Abstract: Executives emphasized the role of "comprehensive diagnostics" in its plan to establish a dominant position in immuno-oncology drugs at this years' American Society of Clinical Oncology annual meeting.
      PubDate: Thu, 18 Jun 2015 14:25:01 -040
  • Warning Letter Roundup & Recap – June 16, 2015
    • Abstract: FDA instructed BioLab-St. Joseph to hire an outside expert to audit the firm’s manufacturing and quality assurance systems; CooperSurgical didn't submit MDRs to FDA in a timely fashion; and more.
      PubDate: Thu, 18 Jun 2015 14:00:01 -040
  • FDA Approves Edwards' Sapien 3 TAVR System Earlier
           Than Expected
    • Abstract: The third-generation transcatheter aortic valve has been available in Europe for over a year, will have a long head-start on rival Medtronic's next generation TAVR, Evolut R, in the U.S. market.
      PubDate: Wed, 17 Jun 2015 18:30:01 -040
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