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  The Gray Sheet
   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1214
   Published by Informa plc Homepage  [13 journals]
  • Breakthrough Device Route, Registries On Wish List At Senate Hearing
    • Abstract: Industry stakeholders listed their priorities to improve the medical regulatory process and research during a second hearing at the Senate Health, Education, Labor and Pensions Committee which is working on its own version of the House's 21st Century Cures bill.
      PubDate: Tue, 24 Mar 2015 18:25:02 -040
  • Impella 2.5 PMA Gives Abiomed Big Growth Potential
           For High-Risk PCIs
    • Abstract: The approval, the first for a percutaneous hemodynamic support device, frees Abiomed's hand to market the miniature blood pump to a relatively broad patient population, analysts note.
      PubDate: Tue, 24 Mar 2015 17:30:00 -040
  • People Briefs: Calhoun Vision, Benvenue Medical, Urologix, Pentax
    • Abstract: Calhoun Vision appoints CEO. Urologix, Benvenue Medical hire CFOs.
      PubDate: Tue, 24 Mar 2015 15:00:06 -040
  • FDA Warning Letters: March 24
    • Abstract: Failure to gain clearance or approval was the main focus of the two device-related warning letters posted by the agency on March 24. FDA says Zizion Group is selling its blood platelet-rich plasma prep kits without any clearance or approval and that Tiller Mind Body modified its colon irrigation system without regulatory go-ahead
      PubDate: Tue, 24 Mar 2015 15:00:02 -040
  • Industry Proposes Its FDA Guidance Priorities, Reforms
    • Abstract: After FDA published its annual lists of guidance priorities, industry has responded by stating what guidances companies would like to see. Meanwhile, the push for broader reforms to the guidance-development process continues.
      PubDate: Mon, 23 Mar 2015 15:00:01 -040
  • Message From The Editor: More 'Quality' Coverage Ahead
    • Abstract: On April 1, our medical device quality control-focused sister publication, "The Silver Sheet," will join "The Gray Sheet" to form one comprehensive resource for industry. The incorporation of "Silver" into "Gray" establishes a more robust offering for us to invest in and build on to best meet our readers' specialized information needs in the years ahead.
      PubDate: Mon, 23 Mar 2015 13:35:00 -040
  • U.S., Japan Regenerative Medicine Groups Forge Closer Ties
    • Abstract: A major international regenerative medicine group has taken steps to more closely collaborate with a counterpart in Japan, which is prioritizing the development of the sector as a strategic national priority, to improve coordination and information exchange.
      PubDate: Mon, 23 Mar 2015 00:01:38 -040
  • Patent Troll Legislation Gets Attention At Senate Hearing
    • Abstract: Biotechnology Industry Organization throws support behind Senate bill’s revisions to the inter partes review process, argues against provisions in House measure.
      PubDate: Mon, 23 Mar 2015 00:01:23 -040
  • Boston Scientific, Alcon Hit With Gender Discrimination Suits
    • Abstract: The same law firm filed separate class-action suits last week against the two medical technology companies charging gender discrimination.
      PubDate: Mon, 23 Mar 2015 00:00:00 -040
  • TAVR Researchers Look To Lower-Risk Patients, Less Data Demands
    • Abstract: Edwards Lifesciences' Sapien 3 valve looked good at the annual American College of Cardiology conference, including in intermediate-risk patients. Could it mean less follow-up demands for future approvals?
      PubDate: Fri, 20 Mar 2015 12:00:00 -040
  • More Companion Diagnostic Deals For Qiagen And Myriad
    • Abstract: Qiagen’s agreement Tokai Pharmaceuticals targets circulating tumor cells, and Myriad Genetics has extended its partnership with BioMarin Pharmaceutical focused on Myriad's myChoice HRD companion diagnostic.
      PubDate: Thu, 19 Mar 2015 17:05:03 -040
  • SGR Replacement Bill Resurfaces In Congress
    • Abstract: Lawmakers are taking another shot at permanently reforming the Medicare physician payment system. The plan so far does not contain any major provisions targeting device payments, but it is a work in progress.
      PubDate: Thu, 19 Mar 2015 16:20:01 -040
  • Burgess Interoperability Bill Gets Pushback From Health IT Group
    • Abstract: While stating it supports more Congressional oversight and federal agency involvement in developing interoperability requirements for electronic health record systems, the Healthcare Information and Management Systems Society says it is concerned an interoperability bill being floated by Rep. Burgess could set the industry back.
      PubDate: Wed, 18 Mar 2015 18:10:01 -040
  • Let's Talk About Risk: FDA Plans Meeting On Postmarket Risk Management
    • Abstract: FDA says it will hold an interactive workshop on April 21 to discuss the "clinical considerations of risk in the postmarket environment." The meeting will build on a process launched last fall when representatives from industry and FDA met to establish draft principles for managing unanticipated risks for marketed devices.
      PubDate: Wed, 18 Mar 2015 17:50:02 -040
  • Medtronic Funds Diabetes App Firm To Help Target Pump-Monitor Systems
    • Abstract: The medtech giant is one of two new investors in startup Glooko, which has a 510(k)-cleared diabetes management app that it now wants to integrate with insulin pumps, continuous glucose monitors and predictive algorithms.
      PubDate: Wed, 18 Mar 2015 17:40:01 -040
  • Boston Scientific Gets Early Nod For Next Gen S-ICD
    • Abstract: Boston's Emblem S-ICD upgrade was approved by FDA and in Europe earlier than anticipated.
      PubDate: Tue, 17 Mar 2015 17:10:00 -040
  • FDA Warning Letters: March 17
    • Abstract: The agency posted two device-related warning letters March 17, including a missive to Arizona-based Winter Goals for selling test kits tied to "alternative cancer treatments" without FDA clearance or approval.
      PubDate: Tue, 17 Mar 2015 17:00:01 -040
  • FDA Recalls List – March 11, 2015
    • Abstract: The agency's March 11 enforcement report includes a class I action from Boston Scientific and 32 device recalls in total.
      PubDate: Tue, 17 Mar 2015 16:55:00 -040
  • CardioMEMS Heart Failure Monitor Shows Mortality,
           Hospitalization Benefit
    • Abstract: A retrospective analysis presented at the American College of Cardiology meeting in San Diego shows that pulmonary artery pressure monitoring with St. Jude’s CardioMEMS reduced hospitalization and mortality in patients with heart failure and reduced ejection fraction.
      PubDate: Tue, 17 Mar 2015 16:45:01 -040
  • MITA Adds Regulatory Director To Enhance Standards Efforts
    • Abstract: Hayes will lead the imaging and radiation therapy trade group's efforts to identify opportunities for performance, quality and safety standards, while also promoting current standards with regulators, industry and standards development organizations.
      PubDate: Mon, 16 Mar 2015 17:30:00 -040
  • Boston Sci’s Watchman Stroke Device Finally
           Nabs FDA Approval, With Favorable Labeling
    • Abstract: Three separate FDA advisory panels examined the clinical data supporting the left-atrial appendage closure device and struggled to identify exactly which patients it benefits. But FDA has finally approved Watchman with an indication that analysts say will support meaningful market action for Boston Scientific.
      PubDate: Mon, 16 Mar 2015 17:00:01 -040
  • Medtronic Starts Next-Gen Drug-Eluting Stent Trials
    • Abstract: The company is initially targeting very small vessels in a new pivotal study for its Resolute Onyx zotarolimus-eluting stent. Medtronic is separately launching a study of its novel "drug-filled" stent platform.
      PubDate: Mon, 16 Mar 2015 17:00:00 -040
  • FDA Recalls List – March 4, 2015
    • Abstract: The agency's March 4 enforcement report includes class I actions from Hospira and HeartWare, and 89 device recalls in total.
      PubDate: Mon, 16 Mar 2015 00:01:16 -040
  • India’s Device Makers Face Heightened Scrutiny Of Marketing
    • Abstract: The Indian government has extended a uniform code of marketing practices to the device industry. While global device makers appear to have implemented internal compliance guidelines, a local association of device manufacturers believes multinational companies have shared 'supernormal' margins with distributors, leading to inflated prices.
      PubDate: Mon, 16 Mar 2015 00:01:10 -040
  • FDA Lays Down Strict Disinfection Guidance In Wake Of Scope Incidents
    • Abstract: The agency sped up release of a final guidance on reprocessing reusable devices, including a strict set of protocols for endoscope cleaning, disinfection data, and design guidelines, following reports of serious bacterial infections linked to duodenoscopes.
      PubDate: Mon, 16 Mar 2015 00:00:55 -040
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