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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]
  • NIH Awards $200K For Wearable Alcohol Tracker
    • Abstract: The National Institutes of Health challenged researchers to improve on current technology for tracking alcohol consumption. The winner was a wristband monitoring technology developed by the firm BACTrack.
      PubDate: Mon, 23 May 2016 17:30:01 -040
  • FDA Recommends HHS-Certified EHRs For Clinical Trials
    • Abstract: Clinical trial sponsors are free to use any electronic health record system that meets FDA standards to collect clinical trial data, but the agency recommends use of Office of the National Coordinator for Health Information Technology-certified systems to better ensure that the EHR meets requirements for interoperability, reliability and confidentiality.
      PubDate: Mon, 23 May 2016 17:00:01 -040
  • World Health Organization Issues Draft Framework For Device Regulation
    • Abstract: WHO is seeking input on a proposed assessment model that will be offered as a best-practices guide for nations still developing device regulations. The model could also someday provide a basis for WHO itself to assess devices.
      PubDate: Mon, 23 May 2016 10:00:01 -040
  • Device Week – May 23, 2016
    • Abstract: On this week's podcast, we discussed two FDA initiatives related to facility inspections, comments from Jeff Shuren on device evaluation and cybersecurity, an agency postmarket surveillance guidance, device regulation efforts from the World Health Organization and some legal updates.
      PubDate: Mon, 23 May 2016 00:01:48 -040
  • Edwards Declares Victory In Transcatheter Mitral Valve Contract Suit
    • Abstract: A jury recommended a $70m award to Edwards Lifesciences unit CardiAQ based on findings that another firm, Neovasc, breached a supplier contract and used CardiAQ's trade secrets to develop a competing transcatheter mitral valve device.
      PubDate: Fri, 20 May 2016 13:00:02 -040
  • Senate Seeks Performance Data From FDA On De Novos,
           Postmarket Surveillance
    • Abstract: A Senate panel directs FDA to meets its statutory deadlines for de novo reviews and device risk classifications of devices, and requests data on those programs – as well as for the agency's postmarket device surveillance activities – in a 2017 appropriations bill.
      PubDate: Thu, 19 May 2016 18:20:01 -040
  • Big Problems At A Syringe Supplier Led To B. Braun's $7.8m Settlement With
    • Abstract: The company distributed contaminated syringes manufactured by a third party despite repeated indications that not all was well with the supplier's practices, the Department of Justice says.
      PubDate: Thu, 19 May 2016 17:45:01 -040
  • Roche Wins 'Complimentary' Diagnostic Approval With Bladder Cancer Immune
    • Abstract: FDA approved Roche's Ventana PD-L1 assay to help identify patients more likely to respond to its Tecentriq drug for bladder cancer. It's approved as a helpful tool, rather than required test, with the drug, but the assay is part of a growing class of diagnostics that are likely to play an important supporting role in a promising and high-growth branch of oncology.
      PubDate: Thu, 19 May 2016 14:30:01 -040
  • Would-Be FDA 'Maturity Model' Pilot Might Reward Firms With Delayed
    • Abstract: "Mature" device manufacturers could put off an FDA inspection for a few years if they independently verify that they have robust quality metrics in place under a potential pilot program, CDRH's new compliance head says. The pilot would be part of FDA's plan under its Case for Quality to use a maturity model to prioritize facility inspections.
      PubDate: Thu, 19 May 2016 12:35:03 -040
  • MDUFA Negotiations Mellow Out Over Opposing Wish Lists
    • Abstract: As FDA and industry struggle to align on reform priorities for a cost-conscious user-fee reauthorization proposal, the two sides took a step back to examine basic assumptions at a recent closed-door meeting.
      PubDate: Thu, 19 May 2016 11:20:01 -040
  • Medtronic Nabs Smith & Nephew's Gynecology Business
    • Abstract: The $350m deal basically involves one product, Smith & Nephew's Truclear hysteroscopic uterine tissue removal system.
      PubDate: Wed, 18 May 2016 18:00:01 -040
  • US Urges High Court To Take Patent Case Claiming Overseas Inducement
    • Abstract: The case between Promega and Life Tech turns on whether a company violates US patent law by shipping a single allegedly patented component overseas for assembly. The Solicitor General’s office says it does not, arguing that the Federal Circuit’s reading would expose US manufacturers to too much risk of patent liability.
      PubDate: Wed, 18 May 2016 17:45:02 -040
  • CMS Targets Leadless Pacers For Medicare Coverage Analysis
    • Abstract: The Medicare agency wants input on the scientific evidence supporting leadless pacemakers so it can establish a national coverage policy for the technology, which entered the US market for the first time last month.
      PubDate: Wed, 18 May 2016 17:30:00 -040
  • Siemens Makes First Molecular Dx Buy In Nine Years
    • Abstract: The firm's health-care division bought private next-generation sequencing firm NEO New Oncology for an undisclosed amount.
      PubDate: Wed, 18 May 2016 14:00:00 -040
  • Luminex Buys Nanosphere, Citing Infectious Disease Dx Strengths
    • Abstract: Diagnostics firm Luminex will add Nanosphere's Verigene bloodstream-infection testing platform and its molecular microbiology strength to broaden its reach in the lab market.
      PubDate: Wed, 18 May 2016 13:00:02 -040
  • Shuren To Industry: 'Hire A Hacker'
    • Abstract: Companies say cybersecurity threats keep many CEOs awake at night. CDRH Director Jeff Shuren urge them to consider hiring hackers to conduct penetration testing of their medical devices and help ensure stronger security on their products.
      PubDate: Tue, 17 May 2016 18:40:01 -040
  • Fresh Lawsuits Target Vena Cava Filters
    • Abstract: Two patients who say they were injured by vena cava filters made by Cook and Boston scientific filed suit against the manufacturers in Kentucky federal court earlier this month. The suits build on safety concerns about the filters previously circulated by FDA and researchers.
      PubDate: Tue, 17 May 2016 17:35:00 -040
  • ORA Device Director: Inspection 'Program Alignment' Scheme Not Ready
           Anytime Soon; Investigator Training, Retention Pose Challenge For FDA
    • Abstract: More details about FDA's new commodity-specific inspectional approach continue to emerge, including news that the Office of Regulatory Affairs is under pressure to train agency investigators while simultaneously dealing with the loss of several highly trained auditors to the agency's device center. All of this comes amid a sign-off process on "program alignment" that will extend all the way to Capitol Hill.
      PubDate: Tue, 17 May 2016 15:50:01 -040
  • Warning Letter Roundup & Recap – May 17, 2016
    • Abstract: Premarket authorization problems noted at maker of the Eclipse Micro-Pen Elite device for the treatment of wrinkles. The firm was the only recipient of a device warning letter listed by FDA this week.
      PubDate: Tue, 17 May 2016 11:10:01 -040
  • New European Regulations Could Be Made Public In August
    • Abstract: Device and diagnostics companies could get a look at the future regulatory realties in Europe as soon as August if EU policy-makers maintain current progress on negotiating new broad-reaching regulations.
      PubDate: Mon, 16 May 2016 17:00:00 -040
  • Software Poses Unique Challenges For Both Device Firms And FDA; Recurrent
           Troubles With Software Testing, Design Control, Documentation A Concern
    • Abstract: From our digital archives: Problems with device software, such as the use of aging microprocessors and platforms, alarm FDA, said Al Taylor with the agency's Office of Science and Engineering Laboratories, who said the agency has “seen several instances where problems arose because the firm was way, way past the point where a prudent person would have made the choice to move to a more powerful and capable platform." Companies are also falling down on software quality by not following design controls, not conducting testing and failing to create thorough requirements documents. The internationa...
      PubDate: Mon, 16 May 2016 13:20:02 -040
  • FDA '522' Guidance: 15-Month Deadline To Comply With Postmarket Order
    • Abstract: The agency issued a final guidance on Section 522 postmarket study orders, about five years after a draft version. In the interim Congress stipulated a 15-month deadline for companies to start the FDA-mandated studies, a requirement emphasized in the new document.
      PubDate: Mon, 16 May 2016 12:15:00 -040
  • Device Week – May 16, 2016
    • Abstract: On this week's podcast, Clinica's Amanda Maxwell discusses the final areas of controversy in the European Union "trilogue" talks on new medical device and in vitro diagnostic regulations for the region. The negotiations are expected to wrap up later this month.
      PubDate: Mon, 16 May 2016 00:00:58 -040
  • SurgiBot Sunk' TransEnterix Turns To Alternative
           Robot System After FDA Denial
    • Abstract: The company plans to reduce headcount and investment focused on its SurgiBot laparoscopic robotic surgery system, recognizing that it does not have the resources to put together a new 510(k) and, at the time, prepare a recently acquired system for FDA submission.
      PubDate: Mon, 16 May 2016 00:00:00 -040
  • Medtronic Wins Physician-Filed TAVR Patent Suit
    • Abstract: The US Court of Appeals for the Federal Circuit upheld a Patent Trial & Appeals Board ruling against a doctor who claimed to be the true inventor of technology used in the CoreValve transcatheter aortic heart valve replacement device.
      PubDate: Fri, 13 May 2016 16:00:00 -040
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