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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]
  • Local Coverage With Evidence Development Is Legit, CMS Says In Final
    • Abstract: The Medicare and Medicaid agency issued its final guidance on the coverage-with-evidence-development program, two years following a draft. It is explicit that local Medicare contractors can employ CED in setting coverage policies in their jurisdictions, despite resistance by some device companies and others.
      PubDate: Fri, 21 Nov 2014 14:30:01 -050
  • WHO Launches Initiatives For Ebola POC Tests
    • Abstract: The World Health Organization has initiated a rapid review process and is providing early test validation materials to encourage more manufacturers to quickly develop rapid, point-of-care Ebola tests. Meanwhile, Aethlon Medical is providing its bio-filtration device to treat blood of Ebola patients.
      PubDate: Thu, 20 Nov 2014 18:10:07 -050
  • Ortho Implants For Surgical Sets Granted Unique Device ID Compliance Delay
    • Abstract: Unique device identifiers on packaging for non-sterile orthopedic implants that will be assembled into surgical sets, or trays, will not readily be captured at the point of care. Companies need to implement new strategies to bridge the gap, and FDA will give them an extra year to do so.
      PubDate: Thu, 20 Nov 2014 17:05:02 -050
  • Boston Scientific Touts Synergy Bioabsorbable Polymer Stent Trial Data
    • Abstract: Principle investigator on the Evolve II trial is optimistic the stent will dominate the U.S. market in two to three years.
      PubDate: Wed, 19 Nov 2014 18:20:06 -050
  • Study Results For Unapproved Devices Could Be Heading To
    • Abstract: Under an NIH proposed rule, trial results for products or indications that have yet to be approved or cleared would be subject to posting requirements, with certain allowances for delay. Also, trial registrations for unapproved devices, currently hidden from view, could sometimes see the light of day before FDA acts.
      PubDate: Wed, 19 Nov 2014 18:20:00 -050
  • Clinical Labs Lawyer Up In Battle Over LDTs
    • Abstract: ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.
      PubDate: Wed, 19 Nov 2014 18:15:02 -050
  • Pallone Outflanks Eshoo To Win Top Dem Spot On Energy And Commerce
    • Abstract: Rep. Frank Pallone will be ranking member of the House Energy and Commerce Committee in January, beating out House Medical Technology Caucus Co-Chair Rep.
      PubDate: Wed, 19 Nov 2014 13:25:00 -050
  • Valeant Picks Up Nicox's Diagnostics Unit
    • Abstract: Valeant will pay up to $20 million to gain Nicox's diagnostics unit, including a panel for Sjögren’s syndrome and a lab-developed test for age-related macular degeneration.
      PubDate: Tue, 18 Nov 2014 18:00:01 -050
  • FDA Recalls List – November 12, 2014
    • Abstract: The agency's Nov. 12 enforcement report includes 25 class I and II actions, including class I recalls from Baxter and Trivascular,
      PubDate: Tue, 18 Nov 2014 17:05:01 -050
  • bioMérieux, Illumina to Develop Sequencing Products for Hospitals
    • Abstract: The companies say they will develop “game changing tools” that will help health care providers stop epidemics.
      PubDate: Tue, 18 Nov 2014 16:20:00 -050
  • Longer Anti-Platelet Therapy Reduces Thrombosis Risks With Drug-Eluting
    • Abstract: In patients implanted with drug-eluting stents, dual antiplatelet drug therapy beyond one year significantly reduces the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events compared to aspirin alone, but also increase the risk of bleeding, the Dual Antiplatelet Therapy Trial show.
      PubDate: Tue, 18 Nov 2014 15:10:01 -050
  • Actavis Steps In With $66 Billion White Knight Offer For Allergan, Ending
           Valeant Acquisition Plans
    • Abstract: The generics giant came through with the transformational deal it promised shareholders, bidding $66 billion for Allergan, and effectively wiping out Valeant’s hopes that it could take over the drug and device maker.
      PubDate: Mon, 17 Nov 2014 19:00:02 -050
  • Baxano Plans Asset Sale Following Bankruptcy Filing
    • Abstract: The minimally invasive spine surgery device firm owes at least $7.6 million to its lender and is looking for bankruptcy protection as it plans to sell off its assets.
      PubDate: Mon, 17 Nov 2014 18:10:00 -050
  • Congress Passes Bill That Could Improve Traumatic Brain Injury Diagnostics
    • Abstract: The Traumatic Brain Injury Reauthorization Act passed by the House Nov. 13 authorizes about $15.2 million annually for development and improvement of brain injury diagnostic tools and treatments. S. 2539 was approved by the Senate in mid-September and awaits President Obama’s signature.
      PubDate: Mon, 17 Nov 2014 18:05:16 -050
  • FDA Advisors Recommend Alcon’s Multifocal Toric IOL
    • Abstract: The company received a resounding yes from an FDA panel to approve the lens for cataract surgery to treat presbyobia and astigmatisms..
      PubDate: Mon, 17 Nov 2014 17:50:02 -050
  • New Product Briefs: North American Spine Society
    • Abstract: Product launches last week at the North American Spine Society annual meeting in San Francisco.
      PubDate: Mon, 17 Nov 2014 00:03:21 -050
  • FDA Recalls List – November 5, 2014
    • Abstract: The agency's Nov. 5 enforcement report includes class I recalls from Hospira and Nellcor Puritan Bennett.
      PubDate: Mon, 17 Nov 2014 00:02:46 -050
  • EU Council Resists Parliament Pressure To Pick Up The Pace On Reforms
    • Abstract: The body representing European Union country heads of state continues to lag well behind the European Parliament progress on comprehensive device and diagnostic regulatory reforms, and is resistant to nudges to speed things up.
      PubDate: Fri, 14 Nov 2014 19:00:00 -050
  • MDMA Founding Chair Tommy Thompson Dies At 76
    • Abstract: Thomas "Tommy" C. Thompson, who co-founded three device companies, joined with several others to found the Medical Device Manufacturers Association in 1992 to build a stronger voice for small medtech firms in Washington politics.
      PubDate: Fri, 14 Nov 2014 14:00:02 -050
  • People Briefs: BSD Medical CEO; TransEnterix COO Resigns; Delphinus
    • Abstract: Device industry veteran Clint Carnell named president and CEO of BSD Medical; TransEnterix reports resignation of chief operating officer; Delphinus Medical Technologies appoints VP, finance.
      PubDate: Thu, 13 Nov 2014 19:30:01 -050
  • New Japanese Device Law Takes Hold Nov. 25
    • Abstract: As the deadline approaches for Japan to enforce its first-ever law for regulating medical devices separately from drugs, medtech companies must adapt to the new requirements.
      PubDate: Thu, 13 Nov 2014 16:00:01 -050
  • Senate Vets Emergency Ebola Funding Request, Including Diagnostics, PPE
    • Abstract: The Senate Appropriations Committee vetted a $6.18 billion request for emergency funding from the Obama administration, including funds to accelerate and approve Ebola diagnostics and to buy personal protective equipment.
      PubDate: Thu, 13 Nov 2014 14:30:00 -050
  • ImThera Gets Go-Ahead For Sleep Apnea Nerve Stimulator Pivotal Study
    • Abstract: The aura6000 sleep apnea system has received investigational device exemption approval for a pivotal trial but still lags behind key rival Inspire Medical Systems Inc.’s Inspire upper airway stimulator.
      PubDate: Wed, 12 Nov 2014 18:00:05 -050
  • FDA Warning Letters: Nov. 11
    • Abstract: The agency posted two device-focused warning letters Nov. 11, including one to Vietnam surgical sutures maker Mani Hanoi, for quality system violations.
      PubDate: Wed, 12 Nov 2014 18:00:01 -050
  • Medicrea Custom Spinal Rods Get FDA Nod
    • Abstract: The UNiD spinal rods in combination with Surgimap software are expected to reduce operating time, improve success rates for sagittal alignment surgeries and reduce the risk of rods failing post-surgery, according to the company.
      PubDate: Wed, 12 Nov 2014 17:35:01 -050
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