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Journal Cover   The Gray Sheet
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   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1214
   Published by Informa plc Homepage  [15 journals]
  • Expanded OpenFDA Interface Aims To Improve Device Analysis, App
    • Abstract: FDA's expanded application programming interface for medical device data, including product classifications, registries, listings and approvals and clearances, is intended to help developers and researchers use the information to create new tools to analyze safety and efficacy data.
      PubDate: Thu, 03 Sep 2015 17:15:03 -040
  • Tornier Toes FTC Line With Lower-Extremity Sale To Integra
    • Abstract: Integra is buying the U.S. rights to Tornier's Salto Talaris and Salto XT ankle replacement products and its Futura silastic toe replacement products for an undisclosed cash payment. The deal is intended to satisfy antitrust concerns in Wright Medical's pending purchase of Tornier and to strengthen Integra's position in the lower-extremity market.
      PubDate: Thu, 03 Sep 2015 15:30:01 -040
  • Business Briefs
    • Abstract: Insulin device firm CeQur and liquid biopsy firm Exosome Diagnostics closed financing rounds; Abbott completes its transcatheter mitral valve replacement deal; Unilife considers its options; and Quest Diagnostics subsidiary advances infectious disease offerings.
      PubDate: Thu, 03 Sep 2015 15:00:02 -040
  • Guest Column: Manufacturers, Suppliers Offer Perspectives On Supplier
           Quality Program
    • Abstract: More than 30 companies now participate in the device industry-managed supply chain oversight program MedAccred. “Ultimately, the goal is to achieve a consistently high level of product quality from our special process vendors," Stryker's Bruce Dall explains.
      PubDate: Thu, 03 Sep 2015 14:00:00 -040
  • Pew Urges CMS To Add UDI Data As Part Of Payment Reforms
    • Abstract: Responding to a recent CMS proposed rule, the group says the agency should require unique device identifier data in claims forms to help Medicare avoid overpaying for use of failed or recalled devices.
      PubDate: Wed, 02 Sep 2015 18:20:07 -040
  • In Case You Missed It: Top 10 "Gray Sheet" Stories In August
    • Abstract: Our feature exploring the myriad complications of the ongoing revision process for the international device quality systems standard ISO 13485 attracted the most "Gray Sheet" Web traffic by a long shot last month. Also popular: stories on a gap in warning letter postings; a Google device spinoff; China device reforms; and more.
      PubDate: Wed, 02 Sep 2015 18:20:00 -040
  • More Than Just A VAD Maker: HeartWare Broadens Heart Failure Focus With
           Valtech Buy
    • Abstract: The deal will make HeartWare more of a go-to firm for heart-failure specialists, executives say. It comes soon after St.
      PubDate: Wed, 02 Sep 2015 18:10:02 -040
  • Valeant Builds On Ophthalmic Device Biz With Synergetics Buy
    • Abstract: The pharmaceutical firm signaled commitment to the ophthalmic surgical device space that it entered in 2013 with the purchase of Synergetics, specializing in vitreoretinal surgery.
      PubDate: Wed, 02 Sep 2015 13:00:01 -040
  • Wright Brings New Biologic To U.S. Ortho Space With Augment
    • Abstract: The Augment biologic-based device was approved for use in ankle and hindfoot fusions after overcoming multiple regulatory challenges.
      PubDate: Tue, 01 Sep 2015 17:55:00 -040
  • Medtronic Eyes Aneurysm Coil-Market Disruption With Medina Purchase
    • Abstract: Medtronic acquired Medina Medical, a startup it have previously invested in, for $150 million plus milestones with plans to further commercialize the Medina embolization device to treat cerebral aneurysms.
      PubDate: Tue, 01 Sep 2015 17:45:00 -040
  • Warning Letter Roundup & Recap – September 1, 2015
    • Abstract: Cardiac monitor manufacturer Cardiac Designs didn't have an adequate system for receiving and evaluating complaints forwarded to the firm from a third-party complaint handling company; marketer of the WaveLight EX500 Excimer Laser System – used in LASIK procedures – was cited for premarket reg violations; and more. Four device warning letters were listed by FDA this week.
      PubDate: Tue, 01 Sep 2015 16:45:01 -040
  • Warning Letter Close-Outs – August 2015
    • Abstract: Seven FDA close-out letters were released in August.
      PubDate: Tue, 01 Sep 2015 15:20:01 -040
  • FDA Issues Recalls For Alaris Infusion Pumps
    • Abstract: The agency designated two recalls linked to infusion pumps as class I actions based on concerns with a device alarm system in one case and a fluid retention membrane in the other.
      PubDate: Tue, 01 Sep 2015 14:05:02 -040
  • WHO Moves Ahead On Model Regulations For Medtech
    • Abstract: The World Health Organization is working on an updated framework to help national agencies set up medical device regulatory systems, with plans to finish off a guidance document next year.
      PubDate: Mon, 31 Aug 2015 18:00:02 -040
  • FDA Grants Emergency Authorization For MERS-CoV Test
    • Abstract: Altona Diagnostics GmbH has received emergency-use authorization for its Middle East Respiratory Syndrome Coronavirus diagnostic.
      PubDate: Mon, 31 Aug 2015 17:30:00 -040
  • Nanostim Meets Goals In Short Trial, But Big
           Questions Remain For Leadless Pacemakers
    • Abstract: St. Jude's leadless pacemaker met its endpoints in the 526-patient LEADLESS II trial, but the 6.7 percent adverse event rate triggered questions at the European Society of Cardiology Congress, and investigators underscored the current limitations of leadless devices compared to conventional pacemakers.
      PubDate: Mon, 31 Aug 2015 17:05:02 -040
  • New CMS Lab Test Panel Meets To Make Payment Policy Recommendations
    • Abstract: The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests held its inaugural meeting Aug. 26 to begin work on recommending crosswalks and gapfills for more than 25 molecular tests codes.
      PubDate: Mon, 31 Aug 2015 00:00:56 -040
  • Device Week Podcast – Episode 12
    • Abstract: This week, we discussed a new report from the FDA-sanctioned Medical Device Registry Task Force, feedback to the agency on patient-preference data, MRI compatibility launches, the Abbott-St. Jude acquisition rumor and more.
      PubDate: Mon, 31 Aug 2015 00:00:49 -040
  • Pressure On CMS To Add UDI To Claims Forms Continues
    • Abstract: The West Health Institute has joined a group of stakeholders calling for incorporating Unique Device Identifier codes in reimbursement claims forms to improve postmarket surveillance. But hospital and physician groups continue to push against the notion, stating it would create unnecessary burdens.
      PubDate: Fri, 28 Aug 2015 18:00:01 -040
  • Abbott Denies St. Jude Acquisition Report, But Here's How The Firms Line
    • Abstract: A media report stating Abbott was readying to buy St. Jude Medical was quickly shot down by the company.
      PubDate: Thu, 27 Aug 2015 18:00:02 -040
  • Boston Makes Big European Push In MRI Compatibility
    • Abstract: Boston Scientific says it now has the largest MRI-compatible portfolio in Europe with the recent CE marks for ImageReady labeling for a range of implantable defibrillators and cardiac resynchronization therapy devices.
      PubDate: Thu, 27 Aug 2015 15:50:00 -040
  • People Briefs: EnteroMedics, Direct Flow Medical, Veracyte, VolitionRx,
    • Abstract: EnteroMedics founder and CEO to retire, Direct Flow Medical appoints VP, regulatory and clinical affairs, Veracyte names chief medical officer, and more personnel updates from around the industry.
      PubDate: Wed, 26 Aug 2015 18:15:02 -040
  • Regulatory News Briefs: New CDRH Communications Chief, And More
    • Abstract: FDA's device center appointed an agency veteran who also has industry trade group experience as its new external relations chief to oversee strategic communications, the next Unique Device Identification database compliance deadline has been pushed by one month, and more regulatory news.
      PubDate: Wed, 26 Aug 2015 18:10:06 -040
  • Warning Letter Roundup & Recap – August 25, 2015
    • Abstract: Maker of the Crono S-PID-50 infusion pump cited for quality system deficiencies, including failing to investigate 26 maintenance reports that included complaints; a contract sterilizer didn't validate the sterilization of disposable tubing sets used with Euromi's EVA Sp6 device; and more. Four device warning letters were listed by FDA this week.
      PubDate: Wed, 26 Aug 2015 18:00:00 -040
  • Firms Bristle At Labeling Requirements For Patient-Preference Data
    • Abstract: Device manufacturers say labeling recommendations in FDA's recent draft guidance on applying patient-preference information for device submissions is burdensome and may lead to confusion among doctors and patients. Meanwhile, Public Citizen says FDA should abandon the guidance because it lowers approval standards.
      PubDate: Wed, 26 Aug 2015 14:45:01 -040
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