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Journal Cover The Gray Sheet
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   ISSN (Print) 1530-1214
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  • Device Hacks Becoming More Sophisticated, Targeted, Security Firm Warns
    • Abstract: An updated report from the cybersecurity solutions firm TrapX Security outlines several case studies that suggest malicious hackers are not only becoming more intent on attacking medical devices to infiltrate health-care networks for their patient data, but that their attacks have become more sophisticated in bypassing best-practice solutions.
      PubDate: Thu, 07 Jul 2016 17:45:03 -040
  • House Panel Passes Infectious-Disease Fighting Fund
    • Abstract: The House Appropriations Committee's Labor/HHS Subcommittee approved an additional $300m in funding next year for an "Infectious Disease Rapid Response Reserve Fund" to be run by the Centers for Disease Control and Prevention.
      PubDate: Thu, 07 Jul 2016 17:35:21 -040
  • NuVasive To Settle Medtronic Spinal Patent Suit
    • Abstract: The spinal device manufacturer is paying $45m to put the dispute to bed – less than half of a 2011 jury award.
      PubDate: Thu, 07 Jul 2016 17:00:03 -040
  • Senate Finance Hearing To Focus Stark Self-Referral Law Exceptions
    • Abstract: The Senate Finance Committee plans to debate potential reforms and exceptions to the Stark self-referral law for health-care companies and physicians on July 12 to make the statute better support alternative Medicare payment models. And the committee has released a white paper on the topic.
      PubDate: Thu, 07 Jul 2016 13:25:01 -040
  • FDA Maps Out Novel Path For NGS Market Access
    • Abstract: FDA Commissioner Robert Califf says the agency has worked with NIH and other experts as part of President Obama's Precision Medicine Initiative to map out a new regulatory framework for next-generation sequencing. He said two new draft guidances are meant to help get such tests to market sooner without requiring developers to validate individual genetic variations.
      PubDate: Wed, 06 Jul 2016 23:40:01 -040
  • Expedited Access Pathway Devices
    • Abstract: A sortable and searchable listing of devices accepted by FDA into its Expedited Access Pathway program, as disclosed by product developers. Latest update: July 6.
      PubDate: Wed, 06 Jul 2016 17:40:00 -040
  • 2016 PMA Supplements
    • Abstract: A sortable and searchable table of PMA supplements approved by FDA in calendar year 2016, updated monthly. Thirty-day notices excluded.
      PubDate: Wed, 06 Jul 2016 17:35:04 -040
  • 2016 Original PMAs And Panel-Track Supplements
    • Abstract: A sortable and searchable table of FDA original PMAs and panel-track supplements approved in calendar year 2016, updated monthly. Latest update: approvals through June 30.
      PubDate: Wed, 06 Jul 2016 17:35:00 -040
  • 2016 De Novo Classifications
    • Abstract: A sortable and searchable table of de novo classification decisions in calendar year 2016, updated monthly. Latest update: decisions through June 30.
      PubDate: Wed, 06 Jul 2016 17:30:12 -040
  • 2016 510(k) Clearances
    • Abstract: A sortable and searchable table of 510(k)s cleared by FDA in calendar year 2016, updated monthly. Latest update: clearances through June 30.
      PubDate: Wed, 06 Jul 2016 17:30:00 -040
  • Warning Letter Roundup & Recap – July 11, 2016
    • Abstract: QS and MDR problems noted at Zimmer's Montreal plant, and at Italian manufacturer of infusion and transfusion kits and needles. FDA released warning letters to two device companies this week.
      PubDate: Tue, 05 Jul 2016 18:00:01 -040
  • For How Much Longer Is Your CE Marking Valid' Transitioning Under The
           New EU Regulations
    • Abstract: The texts of the pending EU medical device and IVD regulations are difficult to interpret when it comes to transitional arrangements for CE marks. Clarification from government bodies will likely be needed, but this article seeks to bring some clarity on the topic.
      PubDate: Tue, 05 Jul 2016 17:25:05 -040
  • Abbott Launches First Fully Absorbing Stent In US Market
    • Abstract: Abbott looks to Absorb GT1, the first fully bioresorbable coronary scaffold to gain FDA approval, to help accelerate growth. But it still has yet to be shown superior to conventional drug-eluting stents, and it also has metal stents with bioresorbable polymers to contend with.
      PubDate: Tue, 05 Jul 2016 17:15:01 -040
  • In Case You Missed It: Top 10 Gray Sheet Stories In June
    • Abstract: The most popular online stories last month in The Gray Sheet included a "Compliance Corner" piece on nightmare scenarios firms have experienced during facility inspections; a scoop on the new chief of device evaluations at FDA; and our coverage of the dynamic regulatory situation in Europe.
      PubDate: Tue, 05 Jul 2016 16:20:00 -040
  • People Briefs
    • Abstract: Epigenomics, RainDance, and Brightree name new leadership, and more personnel news from around the industry.
      PubDate: Tue, 05 Jul 2016 13:00:01 -040
  • An Independent FDA: An Idea Whose Time Is Still Coming
    • Abstract: Despite strong support from six former agency commissioners, the notion of an FDA that is independent from HHS is likely to remain theoretical, at least for the near term.
      PubDate: Mon, 04 Jul 2016 10:00:01 -040
  • Device Week – July 4, 2016
    • Abstract: On this week's podcast, we discuss the "Cancer Moonshot" Summit and the hopes medtech stakeholders have for the initiative; Roche's liquid biopsy plans; a guideline from FDA on handling potential advisory-panel-member conflicts of interest and the latest on the "Open Payments" database.
      PubDate: Mon, 04 Jul 2016 00:02:16 -040
  • Warning Letter Close-Outs – June 2016
    • Abstract: Four device-related close-out letters were released by FDA in June.
      PubDate: Fri, 01 Jul 2016 13:01:42 -040
  • CMS Says 'Open Payments' Data Easier To Use, But Some See Reporting
    • Abstract: As CMS releases its 2015 "Open Payments" data on device and drug company payments to physicians, the agency is citing improvements in search tools and usability of the data. But one small startup device firm described onerous and inefficient reporting requirements, and the American Medical Association is citing "registration challenges" and continued data errors on the physician end.
      PubDate: Thu, 30 Jun 2016 18:35:01 -040
  • HeartWare VAD Battery Alert Tagged As Class I Recall
    • Abstract: An FDA recall notice states that HeartWare, which is being acquired by Medtronic, has recalled almost 19,000 ventricular-assist device batteries due to a risk of losing charge prematurely.
      PubDate: Thu, 30 Jun 2016 17:30:02 -040
  • Medtronic Takes Next Step As Heart-Failure Service Provider
    • Abstract: The firm signaled its plan three years ago to transform itself into more of a services partner for hospitals than a product supplier. It took the latest step in that direction with the launch of service for heart-failure management, combing data from its cardiac rhythm management devices and its remote-monitoring offerings.
      PubDate: Thu, 30 Jun 2016 16:00:14 -040
  • FDA Panel To Ponder Approval Factors For OTC Infectious Disease
    • Abstract: FDA plans to hold an advisory panel meeting in mid-August to discuss the potential risks and benefits of clearing or approving over-the-counter infectious disease tests.
      PubDate: Thu, 30 Jun 2016 15:35:01 -040
  • More To FDA AdComm Selection Process Than Meets The Eye
    • Abstract: FDA issued a draft guidance on how it addresses "appearance issues" when it comes to reviewing conflicts of interest in prospective members of an advisory committee. The agency says the guidelines are needed due to a general lack of understanding about how FDA selects and evaluates members of its panels, and how it grants waivers to participate.
      PubDate: Thu, 30 Jun 2016 13:00:00 -040
  • Warning Letter Roundup & Recap – June 28, 2016
    • Abstract: Marketer of the HemaSpot dried blood spot collection device cited for premarket reg violations; QS and premarket reg citations noted at maker of OTC iontophoresis devices; and more. FDA released warning letters to three device companies this week.
      PubDate: Wed, 29 Jun 2016 18:00:23 -040
  • Moonshot Opportunities: Dx Reimbursement, Radiation Therapy Among Medtech
           Focal Points
    • Abstract: Personalized-medicine advocates say Vice President Biden's "Cancer Moonshot" initiative is a great opportunity, but it should be putting more focus on the importance of Medicare policies in driving cancer innovation. There is also a push in the medtech space to raise the profile of radiation therapy as a central tool for treating cancer.
      PubDate: Wed, 29 Jun 2016 18:00:04 -040
School of Mathematical and Computer Sciences
Heriot-Watt University
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