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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]
  • J&J Enters LAA Closure Market In Earnest With Coherex Buy
    • Abstract: J&J's Biosense Webster heart-rhythm device unit has acquired privately held partner Coherex Medical, solidifying its stake in the left atrial appendage closure market that Boston Scientific currently leads.
      PubDate: Fri, 20 Nov 2015 16:40:00 -050
  • Texas Court: Device Companies Not Protected As Health Care Providers
    • Abstract: Texas state law sets a high procedural bar for patients seeking to sue health care providers for malpractice. But a state appeals court has ruled that most device companies do not fit within the Texas Medical Liability Act’s definition of providers.
      PubDate: Fri, 20 Nov 2015 14:00:00 -050
  • FDA Mulls Standards For Neurodiagnostic Tools
    • Abstract: The noninvasive tests of cognitive functioning hold a great deal of promise, but have not yet been fully validated, experts said at a meeting convened by FDA.
      PubDate: Thu, 19 Nov 2015 18:30:00 -050
  • Postmarket Device Surveillance Reforms Raised At Califf Confirmation
    • Abstract: Robert Califf responded to questions about improving postmarket device surveillance during his Nov. 17 confirmation hearing, including from HELP Committee Ranking Member Patty Murray, D-Wash., who raised the issue in relation to tainted duodenscopes that led to the deaths of several people in her state. Califf also addressed questions on lab-developed test oversight and charges that FDA overuses guidance documents.
      PubDate: Thu, 19 Nov 2015 18:00:01 -050
  • FDA MDUFA III Performance, By The Numbers
    • Abstract: Here's a snapshot of FDA's current premarket device review activity in seven graphics.
      PubDate: Thu, 19 Nov 2015 14:50:00 -050
  • Medtronic Lands Aircraft’s Video Laryngoscope For $110m
    • Abstract: Aircraft Medical's McGrath MAC video laryngoscope will become part of Medtronic’s Patient Monitoring & Recovery portfolio in bid by the medtech giant to expand its offerings focused on preventable hospital safety adverse events.
      PubDate: Wed, 18 Nov 2015 16:30:00 -050
  • POD Pressure: Senators Scrutinize Physician-Owned Distributorships At
    • Abstract: A Nov. 17 Senate Finance Committee hearing advanced an ongoing investigation into the impact of physician-owned distributorships of medical devices on health care, including the concerns they raise over potential conflict of interest and risks to patient safety.
      PubDate: Wed, 18 Nov 2015 16:05:01 -050
  • CMS And FDA Stand Together Behind FDA Oversight Of LDTs At House Hearing
    • Abstract: CMS Deputy Administrator for Innovation and Quality Patrick Conway and FDA Device Center Director Jeffrey Shuren told a House subcommittee that legislators’ efforts to replace FDA’s proposed laboratory-developed test framework would lead to duplicative, time-consuming, expensive regulation, and could only result in ineffective and delayed diagnostics that might harm patients.
      PubDate: Wed, 18 Nov 2015 15:45:00 -050
  • ConMed Makes Play For SurgiQuest To Prop Up Surgery Business
    • Abstract: ConMed announced a definitive agreement to acquire the privately held SurgiQuest for $265 million, citing the firm's AirSeal laparoscopic access management technology as a key get for its struggling surgery business.
      PubDate: Tue, 17 Nov 2015 19:00:01 -050
  • Califf Supports Combo Products Pathway At Confirmation Hearing
    • Abstract: FDA's concepts for a new pathway could be ready for congressional scrutiny within a year, Deputy Commission Robert Califf said during his confirmation hearing before the Senate HELP Committee. Most committee members expressed support for Califf's nomination to lead FDA, although he fielded some questions on his ties to industry.
      PubDate: Tue, 17 Nov 2015 18:30:01 -050
  • Warning Letter Roundup & Recap – November 17, 2015
    • Abstract: No device warning letters were released by FDA this week.
      PubDate: Tue, 17 Nov 2015 15:10:02 -050
  • On Eve Of House Hearing, FDA Makes Its Case For LDT Framework
    • Abstract: The agency details 20 case studies to support its planned framework for regulating laboratory-developed tests in a report issued the day before a House subcommittee held a hearing on alternative legislative schemes.
      PubDate: Mon, 16 Nov 2015 18:30:00 -050
  • FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors
    • Abstract: The rare recall order comes as a result of a consent-decree violation by the company, which supplies endoscope reprocessors to almost 3,000 hospitals nationwide. FDA says Custom Ultrasonics has failed to validate its device designs, among other concerns.
      PubDate: Mon, 16 Nov 2015 16:45:01 -050
  • Staff Training Visits On Combo Products, Biocompatibility Sought By FDA
    • Abstract: FDA’s device center is looking for industry volunteers to host staff visits as part the ongoing Experiential Learning Program. Areas of particular interest include biocompatibility, clinical trials, reprocessing and combination products.
      PubDate: Mon, 16 Nov 2015 14:45:00 -050
  • Device Week Podcast – Episode 23
    • Abstract: On this week's podcast, "Gray Sheet" reporters discuss FDA postapproval studies, more on the hospital ICD settlement, unexpected provisions in a Medicare coverage proposal for Boston Scientific's Watchman device, the launch of the US high-intensity focused ultrasound market for prostate cancer and mobile health and cybersecurity issues raised at this year's mHealth Summit.
      PubDate: Mon, 16 Nov 2015 00:03:30 -050
  • Myriad Builds Case For Personalized Rheumatoid Arthritis Drugs
    • Abstract: Data presented at the American College of Rheumatology meeting show that not everybody needs a biologic, and that biomarker testing could enable more cost-effective use, says Myriad subsidiary Crescendo.
      PubDate: Mon, 16 Nov 2015 00:00:14 -050
  • FDA Says It Is Changing Its Cybersecurity Culture, And Others Should Too
    • Abstract: Speaking at the 2015 mHealth Summit, Suzanne Schwartz, the FDA device center's top cybersecurity expert, said the agency is undergoing a cultural shift to better deal with device cybersecurity vulnerabilities and urged manufacturers, security researchers and hospitals to do the same.
      PubDate: Fri, 13 Nov 2015 16:50:01 -050
  • Voices From mHealth 2015: FDA's Suzanne Schwartz On Cybersecurity
    • Abstract: FDA's medical device emergency preparedness leader spoke to "The Gray Sheet" about the agency's progress in cybersecurity, the need to bake security into device design and the product lifecycle, and the importance of collaboration. "The environment in which device and connected systems are utilized in the hospital is an environment that is basically under attack," Schwartz said in a podcast interview from the 2015 mHealth Summit.
      PubDate: Fri, 13 Nov 2015 16:45:00 -050
  • Korea Aims To Nurture Device Sector With Four-Point Plan
    • Abstract: South Korea has released a new strategic plan to support the development of promising medical devices. The measures, which come after a similar grand strategy was released for the biomedicine sector, include plans to fund support new R&D projects, increase clinical trial support centers and designate innovative device firms.
      PubDate: Thu, 12 Nov 2015 18:05:07 -050
  • Patient, Consumer Groups Press For More Oversight Of Device Iterations
    • Abstract: Patient and consumer groups urged better FDA control over modifications to marketed products and expressed support for agency oversight of laboratory-developed tests at a recent update meeting on device user fee reauthorization.
      PubDate: Thu, 12 Nov 2015 16:25:00 -050
  • Warning Letter Roundup & Recap – November 10, 2015
    • Abstract: No device warning letters were released by FDA this week.
      PubDate: Thu, 12 Nov 2015 10:20:02 -050
  • HIFU Face-Off: US Competition Begins For Prostate High-Intensity Focused
    • Abstract: With the 510(k) clearance of EDAP TMS' Ablatherm HIFU and the first US procedure performed with SonaCare Medical's recently cleared Sonablate system, a European rivalry in high-intensity focused ultrasound machines for prostate cancer has moved to the US. And EDAP's CEO argues it was positive for long-term adoption that his firm's system ultimately gained 510(k) clearance as a surgical tool rather than the originally sought PMA approval for a prostate cancer indication.
      PubDate: Wed, 11 Nov 2015 19:40:01 -050
  • Voices From mHealth 2015: Qualcomm Exec Urges Device Firms To Focus On
    • Abstract: As Qualcomm Life continues to build partnerships that allow medical devices to connect through their 2net platform and share patient information, James Mault, the company's chief medical officer, emphasizes that companies should redesign products so they are more user-friendly for patients as devices move to the home setting in this "Gray Sheet" podcast.
      PubDate: Wed, 11 Nov 2015 17:30:00 -050
  • CMS Proposes CED Policy For Watchman With Some
           Unexpected Conditions
    • Abstract: The proposed national coverage decision for the left-atrial appendage closure stroke device would grant Medicare coverage with stipulations, including one provision that appears contradict a key element of FDA labeling and a unique registry requirement.
      PubDate: Wed, 11 Nov 2015 16:55:01 -050
  • Postapproval Cardio Studies Challenged By Enrollment, Protocol Issues
    • Abstract: FDA’s assessments of strengths and weaknesses for eight years’ worth of completed cardiovascular trials show about one-third of studies are challenged by enrollment, protocol or bias issues, according to a graphical analysis by "The Gray Sheet."
      PubDate: Wed, 11 Nov 2015 16:30:01 -050
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