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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]
  • Draft Guidance Docs Should Be Transitory, Industry Insists
    • Abstract: Device industry advocates stressed to CDRH during a meeting last week that draft-guidance documents need to more routinely be finalized or withdrawn in an expedited manner, and that agency staffers must resist using the out-for-comment document as if they are settled policy.
      PubDate: Fri, 06 Jun 2014 18:10:04 -040
  • FDA Schedules Planned Laparoscopic Power Morcellator Panel Meeting
    • Abstract: The Obstetrics and Gynecology Devices Panel will meet next month to discuss the risk of spreading cancer from the use of power morcellation on the uterus and the regulatory implications of the risk following an April safety warning from FDA.
      PubDate: Fri, 06 Jun 2014 17:50:00 -040
  • New Product Briefs
    • Abstract: DexCom’s “professional” continuous glucose monitor, Cook launches Zilver PTX drug-eluting peripheral stent and more product news.
      PubDate: Fri, 06 Jun 2014 17:20:03 -040
  • Coming Together On CLIA Waivers' Industry Hopes To Recruit Patients,
           Providers To Push Reform
    • Abstract: Diagnostic firms formed the Coalition for CLIA Waiver Reform last month with the goal of enlisting patients, labs and physicians in the fight to turn back what they say are unreasonable FDA standards for a test to gain access to the broader market of “waived” labs.
      PubDate: Fri, 06 Jun 2014 11:00:04 -040
  • Roche Renews Focus On Sequencing With Genia Acquisition
    • Abstract: The deal, worth $125 million upfront plus milestones, gives Roche a gateway into the emerging nanopore sequencing segment – the method is expected to “reduce the price of sequencing while increasing speed and sensitivity.”
      PubDate: Fri, 06 Jun 2014 09:00:04 -040
  • Medtronic Looking To Buy Smith & Nephew' Analysts Doubt It
    • Abstract: Medtronic may be looking to buy the British orthopedics device company in part so that it can move its home to the UK for tax purposes, according to a report from Bloomberg. But Securities analysts report that the rumored deal probably does not make sense for Medtronic.
      PubDate: Thu, 05 Jun 2014 17:40:03 -040
  • Burwell Confirmed As HHS Secretary
    • Abstract: The Senate approved Sylvia Mathews Burwell as HHS Secretary on a bipartisan vote. The new secretary recently responded to questions on policy issues from the Senate Finance Committee, including on the pending Sunshine Act payment disclosure database and on imaging reimbursement matters.
      PubDate: Thu, 05 Jun 2014 16:20:47 -040
  • CDRH Looks For Input On Guidance-Development Practices
    • Abstract: FDA’s device center will seek feedback on its guidance development process and best practices at a June 5 workshop.
      PubDate: Wed, 04 Jun 2014 18:00:03 -040
  • NEJM Report: Next-Gen Gene Sequencing Solves Difficult Rare Infection Case
    • Abstract: Clinicians used unbiased next-generation gene sequencing of cerebrospinal fluid in a boy with severe immunodeficiency to discover he was infected with a rare bacterial pathogen. The case, published in the New England Journal of Medicine, suggests next-generation sequencing may help doctors treat patients with diseases that cannot be identified through conventional testing, researchers say.
      PubDate: Wed, 04 Jun 2014 17:00:01 -040
  • HeartWare Warning Letter Cites Quality System Deficiencies
    • Abstract: The implantable ventricular-assist-device firm said it received a warning letter on June 3 based on an FDA inspection of its Miami Lakes, Florida, manufacturing facility in January.
      PubDate: Wed, 04 Jun 2014 15:55:02 -040
  • FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress
    • Abstract: FDA draft guidance documents on glucose meters issued in January propose new accuracy standards that stray from updated international norms and would inappropriately restrict the use of OTC meters in health care facilities when needed, 85 lawmakers from the congressional Diabetes Caucus argue in a letter to Commissioner Hamburg.
      PubDate: Wed, 04 Jun 2014 15:40:03 -040
  • People Briefs: Biosensors, Exosome Diagnostics, SpineGuard
    • Abstract: Biosensors International Group appoints Jose “Pepe” Calle Gordo CEO; Exosome Diagnostics names new CFO and new chief medical officer; SpineGuard taps U.S. marketing director.
      PubDate: Wed, 04 Jun 2014 15:30:01 -040
  • Ex-ArthroCare Chiefs Convicted Of Orchestrating Fraud
    • Abstract: The former top leaders of ArthroCare have been convicted for working in cahoots with distributors to overstate ArthroCare’s earnings. Both face significant prison time for their roles in the scam, according to the Department of Justice.
      PubDate: Wed, 04 Jun 2014 10:40:02 -040
  • Republican Lawmakers Question ONC’s Regulatory Role For Health IT
    • Abstract: Leaders of the House Energy and Commerce Committee sent a letter to National Coordinator for Health IT Karen Salvo challenging her office’s authority to follow through on several recent proposals to regulate health software tools.
      PubDate: Tue, 03 Jun 2014 17:30:08 -040
  • Medicare Will Cover Hepatitis C Screening For Baby Boomers, High Risk
    • Abstract: CMS finalized a decision to cover screening for the Hepatitis C virus under Medicare for all adults born between 1945 and 1965, and all “high risk” adults.
      PubDate: Tue, 03 Jun 2014 17:30:02 -040
  • FDA Warning Letters: June 3
    • Abstract: The agency posted two device-focused warning letters this week, one tied to lack of 510(k) clearance for products and the other targeting quality system concerns.
      PubDate: Tue, 03 Jun 2014 13:40:01 -040
  • Valeant/Pershing To Allergan: Last Chance To Negotiate
    • Abstract: After surprising investors by increasing its bid for Allergan for a second time in one week, Valeant and its activist investor partner Pershing Square, urged management to negotiate before a special meeting is convened to oust the company’s board of directors.
      PubDate: Tue, 03 Jun 2014 13:00:01 -040
  • Decontaminating Reusable Devices After A Terrorist Attack
    • Abstract: FDA scientists presented results of their research on the removal of two dangerous neurotoxins and five select agent pathogens from reusable medical devices following a theoretical terrorist attack or natural disaster, as well as the best decontamination methods, at an June 2 FDA medical countermeasures event.
      PubDate: Mon, 02 Jun 2014 18:00:03 -040
  • FDA Downgrades Molecular Tuberculosis Assays To 510(k) Status
    • Abstract: FDA has reclassified nucleic acid-based diagnostics to detect tuberculosis from respiratory specimens to class II with special controls, moving the rapid tests to a 510(k) rather than PMA standard. Also, the agency codified its prior downclassification of dengue virus serological reagents.
      PubDate: Mon, 02 Jun 2014 00:01:32 -040
  • Where’s Upton' 21st Century Cures Take Temporary Back Seat To
           The Internet
    • Abstract: Republicans dominate first official 21st Century Cures hearing, but Net Neutrality forces many members to choose, and the initiative’s leader makes quick exit.
      PubDate: Mon, 02 Jun 2014 00:00:44 -040
  • Lab21 Merges With Cervical Cancer Screening Firm Novacyt
    • Abstract: The stock-based reverse takeover gives molecular diagnostics firm Lab21 access to Novacyt’s NovaPrep, a second-generation liquid-based cytology screening platform that competes against Roche and Hologic offerings.
      PubDate: Mon, 02 Jun 2014 00:00:39 -040
  • New Product Briefs
    • Abstract: Product launches and approvals from Globus Medical, Qiagen, EUROIMMUN and InControl Medical.
      PubDate: Fri, 30 May 2014 17:00:00 -040
  • Spectranetics Adds Scoring Balloons With AngioScore Acquisition
    • Abstract: The $230 million deal for the maker of AngioSculpt balloon catheters will strengthen Colorado-based Spectranetics’ focus on vessel preparation and plaque modification, and expand its attention to coronary products.
      PubDate: Fri, 30 May 2014 16:10:04 -040
  • House Panel Asks For ‘Prompt Review’ Of Evidence On Dense
           Breast Reporting
    • Abstract: The House Appropriations Committee May 29 approved a flat-level 2015 FDA spending bill. The committee’s report language for the bill urges the agency to expedite its review of evidence supporting the need for breast density reporting in individuals’ mammography reports, and to keep focus on artificial pancreas systems.
      PubDate: Thu, 29 May 2014 18:15:03 -040
  • Medtronic Settles False Claims Case For $9.9 Million
    • Abstract: The company has resolved allegations from the Department of Justice to that it paid illegal kickbacks to doctors to implant Medtronic pacemakers and defibrillators.
      PubDate: Thu, 29 May 2014 16:05:07 -040
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