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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  [16 journals]
  • Quest Wins First Commercial Zika Test FDA Emergency-Use Approval
    • Abstract: FDA approved the first emergency-use authorization for a commercially-developed, molecular-based Zika virus diagnostics, developed by Quest's Focus Diagnostics subsidiary.
      PubDate: Fri, 29 Apr 2016 16:40:00 -040
  • Abbott Tried To Pull Out Of Alere Deal, But It Remains On For Now
    • Abstract: A disclosure from Alere says Abbott did attempt to terminate its agreement to buy the diagnostics company due to an ongoing federal investigation of Alere, but Abbott has reaffirmed its commitment to the deal.
      PubDate: Fri, 29 Apr 2016 13:00:00 -040
  • Third Cardiovascular Giant Coming With $25 Bil. Abbott-St. Jude Deal
    • Abstract: The previously rumored acquisition was announced on April 28, with the firms touting their extensive synergies in the cardiovascular space.
      PubDate: Thu, 28 Apr 2016 19:00:00 -040
  • Bard, J&J Settle Mesh Cases
    • Abstract: CR Bard has settled 150 pelvic mesh claims against the company in West Virginia, while Ethicon paid $5 million to resolve one in New Jersey. An industry observer believes this is part of a trend.
      PubDate: Thu, 28 Apr 2016 18:10:01 -040
  • Class I Recalls, April 2016: Aspiration Catheter, Hemostasis Valves, Lab
           Exam Kits
    • Abstract: Class I recalls in April included Boston Scientific's Fetch 2 aspiration catheter, Focus Diagnostic's Laboratory Examination Kits, and Vascular Solution's Guardian II Hemostasis Valves.
      PubDate: Thu, 28 Apr 2016 17:10:07 -040
  • Risk Classification And The Device-Benefit Question: Cranial
           Electrotherapy Stimulators
    • Abstract: Companies are suspicious of FDA motivations in the drawn-out reclassification process for cranial electrotherapy stimulators. But the case also underscores how the agency's efforts to place devices in the appropriate risk category turns not only on the perceived safety of a device, but evidence supporting its benefits and the types of evidence the agency is comfortable accepting.
      PubDate: Thu, 28 Apr 2016 14:00:01 -040
  • FDA Biocompatibility Tips: Multiple Absorbability, Allergenicity Testing
           Methods To Choose From
    • Abstract: An FDA device reviewer and an agency toxicologist talk to The Gray Sheet about key industry considerations for biocompatibility testing, emphasizing a growing focus on testing absorbable implants and testing for allergens in devices.
      PubDate: Wed, 27 Apr 2016 17:30:06 -040
  • Sensitization Tests: A Roundup
    • Abstract: There are multiple tests acceptable to FDA to evaluate sensitization and allergenicity responses of materials used to make medical devices. The agency's 2013 guidance on the biological evaluation of devices emphasizes two methods in particular, the Guinea Pig Maximization Test (GPMT) and the Local Lymph Node Assay (LLNA) approach.
      PubDate: Wed, 27 Apr 2016 17:30:00 -040
  • Medtech Patent Position Might Be Shakier As Supreme Court Seems To Favor
           IPR Standard
    • Abstract: Chief Justice John Roberts criticizes broad interpretation of patent terms in inter partes reviews, but he seems to be in the minority.
      PubDate: Wed, 27 Apr 2016 17:20:01 -040
  • FDA Investigators Tell What They Look For When Inspecting Facilities
           – But Device Firms Won't Choke If They Adequately Prepare
    • Abstract: Device manufacturers are being reminded by FDA to make sure that everyone in their organization is familiar with procedures related to agency inspections – but firms will be able to handle that and more if they prepare for audits in advance, industry professional Connie Hoy points out. At device firm Cynosure, "we prepare the entire organization, from the CEO down, for an inspection and what to expect," she says in this Gray Sheet "Compliance Corner" feature.
      PubDate: Wed, 27 Apr 2016 14:25:00 -040
  • Reprocessing Provisions Could Be Dropped To Ensure Timely EU Reform
    • Abstract: Sources close to ongoing talks on European regulatory reforms say it's possible that policy-makers could decide to drop sections of proposed regulations addressing EU-wide policies for single-use device reprocessing to speed the overall path to resolution.
      PubDate: Tue, 26 Apr 2016 16:55:06 -040
  • Warning Letter Roundup & Recap – April 26, 2016
    • Abstract: Quality systems problems noted at dental device manufacturer DMP. The firm was the only recipient of a device warning letter listed by FDA this week.
      PubDate: Tue, 26 Apr 2016 16:55:02 -040
  • Positions Diverge In Cost-Conscious User-Fee Negotiations
    • Abstract: As efforts to limit costs of device user-fee reauthorization intensify, the differences in FDA and industry priorities are increasingly on display in ongoing negotiations. In response to industry's call to pare down proposals, FDA returned to the table with a slimmer MDUFA proposal that did not satisfy the other side.
      PubDate: Tue, 26 Apr 2016 13:00:01 -040
  • FDA Moves To Ban Electric Shock Devices Used To Curb Hostile Behavior
    • Abstract: The agency's Neurology Devices Panel previously recommended a ban on the devices, which are used to modify the aggressive behavior of disabled students at one Massachusetts school.
      PubDate: Mon, 25 Apr 2016 17:30:01 -040
  • Trade Groups Protest OTC, QSR-Exempt Hearing Aids At FDA Meeting
    • Abstract: Physicians and manufacturers alike expressed serious concerns with a proposal from White House advisors to make some hearing aids available over-the-counter and exempt from the Quality System Regulation at a recent FDA workshop. They argue the plan could endanger consumers without significantly lowering device costs.
      PubDate: Mon, 25 Apr 2016 12:30:00 -040
  • Califf Puts Weight Behind 'Sentinel' As Evidence-Generation System Of The
    • Abstract: Industry is increasingly supporting the "Sentinel" system for tracking postmarket product performance with claims and other real-world tools, but more companies need to be convinced of the value of the effort in advancing development of next-generation products, rather than simply a tool for safety surveillance, FDA Commissioner Robert Califf told members of the Alliance for a Stronger FDA.
      PubDate: Mon, 25 Apr 2016 10:00:01 -040
  • ResMed Takes CPAP Patent Fight Back To ITC
    • Abstract: The continuous positive airway pressure manufacturer lost a 2013 patent case against BMC when its humidifier patent was ruled invalid due to prior art, but it’s now filed a fresh claim asserting a new and more narrowly tailored patent.
      PubDate: Mon, 25 Apr 2016 09:00:00 -040
  • Device Week – April 25, 2016
    • Abstract: On this week's podcast, The Gray Sheet team talks about renewed TAVR patent battles, hearing aid regulations, the most frequent citation in FDA QSR device warning letters, actions in Congress, Califf's priorities, criticisms of FDA's approach to cybersecurity and an FDA orthopedics panel vote.
      PubDate: Mon, 25 Apr 2016 08:50:00 -040
  • Is Abbott Wavering On Alere Acquisition Plans'
    • Abstract: Comments by Abbott officials during a recent earnings call have fueled questions about whether the firm remains committed to going through with its $5.8 billion purchase of point-of-care diagnostics company Alere, which is under federal investigation for sales practices.
      PubDate: Thu, 21 Apr 2016 17:30:00 -040
  • Despite Data Concerns, Panel Recommends First-In-Class Toe Implant
    • Abstract: Cartiva, a toe implant to treat osteoarthritis, received a strong recommendation from a panel of FDA experts despite suggestions that the device had not fully proven itself.
      PubDate: Thu, 21 Apr 2016 17:20:00 -040
  • FDA Not Impressed With TransEnterix's SurgiBot 510(k)
    • Abstract: The company seeking to make waves in the robotic surgery space hit a major speed bump with a finding by FDA that its SurgiBot did not meet substantial equivalence requirements.
      PubDate: Thu, 21 Apr 2016 17:00:01 -040
  • Make Sure SOPs For FDA Inspections Are Robust, Industry Experts Say
           – And Don't Forget To Train The Receptionist
    • Abstract: In this Gray Sheet "Compliance Corner" feature, Cynosure's Connie Hoy explains how standard operating procedures for FDA inspections are structured at her device manufacturing firm – and urges others to ensure they even have such procedures in the first place. "The purpose of that SOP is to direct the organization toward how you as a company – and the executive management of the company – expect to manage an FDA inspection, or any inspection, for that matter," she says.
      PubDate: Thu, 21 Apr 2016 11:55:00 -040
  • First Endovascular Neural Interface Eyed By New Firm Synchron
    • Abstract: The company launched in Silicon Valley on April 21 with plans to develop a device that can be delivered to the brain with a catheter to record neuron signals that might be used to control an advanced prosthetic.
      PubDate: Thu, 21 Apr 2016 06:10:00 -040
  • Don't Finalize LDT Guidance, House Appropriators Tell FDA
    • Abstract: FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.
      PubDate: Wed, 20 Apr 2016 18:35:01 -040
  • Edwards' TAVR Platforms Challenged In Boston Scientific Patent Suits
    • Abstract: More patent litigation is emerging in the transcatheter aortic valve replacement space with two recent lawsuits alleging that Edwards Lifesciences' Sapien 3 TAVR device and delivery systems violated a total of nine patents held by Boston Scientific.
      PubDate: Wed, 20 Apr 2016 18:00:02 -040
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