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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]
  • Penumbra Launches New Vascular Embolization Device
    • Abstract: The company says its POD system includes anchor technology that helps physicians insert the device and gives them more control when performing vascular embolization procedures. It also announced a new CFO and head of strategy.
      PubDate: Tue, 03 Mar 2015 16:00:02 -050
  • FDA Panel Hands Merz Support For Expanded Radiesse
    Filler Labeling
    • Abstract: The agency's General and Plastic Surgery Devices panel said the benefits outweighed the risks for using Radiesse to augment hand volume.
      PubDate: Tue, 03 Mar 2015 15:00:00 -050
  • Key Device Tax Repeal Questions: Need For An Offset' Veto-Proof Senate
    • Abstract: Cook Medical Chairman Steve Ferguson says any potential offset of the medical device tax would likely be a non-partisan pay-for that could include raising money from savings in other parts of the budget or unexpended funds. Some industry advocates question whether an offset will actually be necessary.
      PubDate: Tue, 03 Mar 2015 14:45:00 -050
  • Boston Sci Ups Urology Focus With $1.6 Billion AMS Deal
    • Abstract: The firm is expanding its leadership position in the urology space with its acquisition of American Medical Systems's men's health and prostate health units.
      PubDate: Mon, 02 Mar 2015 17:10:00 -050
  • Cardinal Health Continues Quest For 'Mature Medical Devices' With Cordis
    • Abstract: The $1.99 billion Cordis acquisition is a major step in Cardinal's strategy to build its offerings of devices with a high physician preference but for which there is limited clinical differentiation and inefficient supply chains.
      PubDate: Mon, 02 Mar 2015 15:40:02 -050
  • Medtronic Buys Bladder-Control Neurostimulation Firm
    • Abstract: Medtronic plans to launch Advanced Uro-Solutions’ 510(k)-cleared Nuro percutaneous tibial nerve stimulation system in the next year following its Feb. 23 acquisition of the firm.
      PubDate: Mon, 02 Mar 2015 00:01:46 -050
  • Rapid Ebola Immunoassay From Corgenix Gains Authorization
    • Abstract: The firm's ReEBOV assay, which can deliver results within 15-25 minutes, is the first rapid test and immunoassay for the Ebola virus granted an emergency use authorization by FDA.
      PubDate: Mon, 02 Mar 2015 00:01:40 -050
  • Earnings Results Roundup: Cyberonics, HeartWare, Lombard
    • Abstract: Financial updates from companies that compete in the neuromodulation, ventricular assist device and endovascular aneurysm repair markets.
      PubDate: Mon, 02 Mar 2015 00:01:23 -050
  • Elekta’s Project Atlantic: A New Blue Ocean For
           Radiation Therapy
    • Abstract: The firm's so-called Project Atlantic radiation therapy system combines high-field real-time MR imaging with state-of-the-art linear technology that Elekta says will take the standard of care to the next level. It is aiming for European and U.S. approvals in 2017.
      PubDate: Sat, 28 Feb 2015 00:00:01 -050
  • FDA Inks Class II Designation For Embryo Viability Tests
    • Abstract: The agency set a class II with special controls designation for assisted reproduction embryo image assessment systems in a Feb. 26 final order, following the de novo decision for Auxogyn’s Eeva system last summer.
      PubDate: Fri, 27 Feb 2015 11:10:01 -050
  • Cyberonics, Sorin Seek Critical Mass With Merger
    • Abstract: The yet-to-be-named combined company is predicting big opportunities, particularly, heart failure, sleep apnea and cardiac surgery.
      PubDate: Thu, 26 Feb 2015 17:50:01 -050
  • FDA Seeks Right Touch For Next-Gen Sequencing With Standards Groups
    • Abstract: The agency and other policymakers see a strong role for third-party standards in supervision of next-generation sequencing as they explore the best role for FDA in the space over the long term.
      PubDate: Thu, 26 Feb 2015 16:40:01 -050
  • Eye Panel Supports Avedro’s Combo Product Despite 'Abysmal' Data
    • Abstract: FDA officials question whether advisory committee votes for Avedro’s drug-device eye treatment were based on reports of similar treatments in medical literature rather than firm’s own data package.
      PubDate: Thu, 26 Feb 2015 12:05:00 -050
  • Health Canada To Regulate Reprocessing of Single-Use Devices
    • Abstract: Commercial reprocessors will be required to meet Canadian requirements for licensing, quality system management, labeling, investigating and handling complaints, maintaining distribution records, conducting recalls, and other activities by 2016, according to a notice sent to select single-use device reprocessors.
      PubDate: Thu, 26 Feb 2015 11:00:01 -050
  • Lawmakers Reintroduce Bill To Prevent FDA User Fee Sequestration
    • Abstract: House representatives are again making a bipartisan bid to prevent FDA user fees from being withheld in a potential sequestration as the administration and Congress come to loggerheads over the president’s new budget.
      PubDate: Wed, 25 Feb 2015 18:00:06 -050
  • Surgical Robot Regs To Be Addressed At FDA Gathering
    • Abstract: The agency plans to tackle major issues related to robotically-assisted surgical devices such as safety and efficacy requirements as well as proper surgical training in what it describes is a “rapidly-developing field” during a two-day summer workshop.
      PubDate: Wed, 25 Feb 2015 18:00:00 -050
  • FDA Approves Medtronic’s VenaSeal To Treat
           Venous Reflux
    • Abstract: VenaSeal was developed by Sapheon Inc., which Covidien acquired in the summer of 2014 shortly after it announced plans to merge with Medtronic.
      PubDate: Wed, 25 Feb 2015 17:10:01 -050
  • CMS Offers Supplemental Payment For Drug-Coated Balloons
    • Abstract: The Medicare pass-through payment will take effect on April 1 in the outpatient setting for Medtronic’s IN.PACT Admiral paclitaxel-coated balloon and C.R. Bard’s Lutonix paclitaxel-coated balloon for treatment of peripheral artery disease.
      PubDate: Wed, 25 Feb 2015 17:00:00 -050
  • Clinical Trial Diversity: ‘How Much More Evidence Do We Need To Move
    • Abstract: FDA seeks research ideas and plans to include demographic subgroup analyses in review templates as some stakeholders call for bolder action to change how companies conduct clinical trials.
      PubDate: Wed, 25 Feb 2015 14:00:01 -050
  • FDA Recalls List – February 18, 2015
    • Abstract: The agency's Feb. 18 enforcement report includes class I actions from Arrow International and Teleflex, and a total of 50 device recalls in all.
      PubDate: Tue, 24 Feb 2015 18:00:00 -050
  • FDA Panel To Weigh In On Neuro Flow Diverter Device Studies
    • Abstract: The agency's Neurological Devices Panel will provide recommendations on study design and data analysis issues for flow diverter devices for aneurysms in April.
      PubDate: Tue, 24 Feb 2015 17:35:00 -050
  • Planning Board Proposes Postmarket Device Surveillance Timeline
    • Abstract: A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.
      PubDate: Mon, 23 Feb 2015 19:20:00 -050
  • Senate HELP Launches "Innovation" Working Group To Consider Device Reforms
    • Abstract: The Senate Health, Education, Labor and Pensions Committee has formed a bipartisan “Innovation Working Group” that will re-examine device and drug regulatory programs, with an eye to getting innovative products to market more quickly.
      PubDate: Mon, 23 Feb 2015 19:10:01 -050
  • Avedro’s Eye Drug-Device Combo Haunted By Past Sponsor’s
    • Abstract: FDA device and drug advisory panels will weigh clinical trial design, low study enrollment and device changes in review of Avedro's application for two orphan eye conditions.
      PubDate: Mon, 23 Feb 2015 17:20:01 -050
  • People Briefs: Owens & Minor, Laurimed, Xagenic, Intersect ENT
    • Abstract: Owens & Minor launched a search to replace its retiring CEO; Laurimed named its new CEO; Xagenic hired a VP of product development; and Intersect ENT appointed a chief commercial officer.
      PubDate: Mon, 23 Feb 2015 00:02:31 -050
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