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The Gray Sheet
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   Full-text available via subscription Subscription journal
     ISSN (Print) 1530-1214
     Published by Informa plc Homepage  [13 journals]
  • FDA Warning Letters: Dec. 16
    • Abstract: FDA issued two device warning letters this week, to Karl Storz Endovision and Voss Plastics.
      PubDate: Tue, 16 Dec 2014 11:00:02 -050
       
  • New Product Briefs
    • Abstract: Dec. 15 was a busy day for diagnostics product announcements, including a clearance for a new cardiac marker, the first FDA CLIA waive for a rapid syphilis screening assay and more.
      PubDate: Mon, 15 Dec 2014 19:00:01 -050
       
  • Smooth Passage Predicted For Bill Renewing R&D Credit
    • Abstract: Easy passage by the Senate of a tax-extenders bill that will retroactively renew the research and development tax credit is expected this week. The bill was also approved by the House Dec. 3.
      PubDate: Mon, 15 Dec 2014 18:40:01 -050
       
  • Industry Says OIG Proposed Gainsharing Rule Could Hurt Innovation
    • Abstract: Medical device groups worry some that proposed provisions and interpretations in a draft OIG rule could expand exemptions for gainsharing agreements between hospitals and physicians that will hinder the ability of innovative products to gain traction in the market.
      PubDate: Mon, 15 Dec 2014 10:00:12 -050
       
  • Welch Allyn Makes Telehealth Deal
    • Abstract: Welch Allyn has acquired the remote patient vital signs monitoring firm HealthInterlink.
      PubDate: Mon, 15 Dec 2014 00:02:07 -050
       
  • Vertiflex Superion Spacer Panel Reset To Give FDA
           More Review Time
    • Abstract: FDA's Orthopaedics and Rehabilitation Devices Panel had planned to consider Vertiflex's PMA for its Superion interspinous spacer device on Dec. 12, but the agency postponed the meeting to Feb. 20 give it more time to review device information.
      PubDate: Mon, 15 Dec 2014 00:01:45 -050
       
  • CDRH Initiatives Underway: Submission Withdrawals, Early Interaction,
           Refuse-To-Accept
    • Abstract: Initiatives to understand what factors drive sponsors to withdraw premarket submissions during review, to find the best ways of informally engaging with sponsors soon after submission and to clarify the 510(k) refuse-to-accept program are among steps highlighted by the device center in its plan to implement recommendations from a third-party assessment.
      PubDate: Mon, 15 Dec 2014 00:01:15 -050
       
  • BD Masters China-Targeted Growth Strategy
    • Abstract: Becton Dickinson has been growing at a better than 20-percent rate several years in a row in China. The reasons, says the firm's China general manager James Deng: Local needs-based product customization and innovation, and commercial partnerships with national players.
      PubDate: Mon, 15 Dec 2014 00:01:09 -050
       
  • CMS Declares Next Round Of DMEPOS Competitive Bidding
    • Abstract: CMS Dec. 11 announces the bidding timeline for a recompete of round 2 of its durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program, as well as the national mail-order program diabetes testing supplies.
      PubDate: Fri, 12 Dec 2014 18:00:00 -050
       
  • Edwards Acquires Option On Cardiokinetix, Developer Of Parachute
           
    Heart Failure Device
    • Abstract: Edwards has purchased an option to buy CardioKinetix after leading a $50 million financing to help the start-up finish its U.S. pivotal trial of the Parachute ventricular partition device for heart failure.
      PubDate: Fri, 12 Dec 2014 17:10:06 -050
       
  • Lawmakers Seek Input On Dx Regs, With Lab-Developed Tests In Focus
    • Abstract: The House Energy and Commerce Committee is seeking feedback on legislative initiatives Congress should enact in 2015 regarding regulation of diagnostics, and in particular in response to FDA's plan to regulate laboratory developed tests.
      PubDate: Fri, 12 Dec 2014 14:00:00 -050
       
  • Medtronic, St. Jude Launch New Quadripolar Devices
    • Abstract: Medtronic has launched two more Attain Performa left ventricular quadripolar leads for the Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators following FDA approval announced Dec. 11. On the same day, St.
      PubDate: Thu, 11 Dec 2014 17:00:01 -050
       
  • FDA Updates Guidance On Labeling Passive Implants For MRI
    • Abstract: The agency has revised a 2008 guidance to spell out when it is OK to state in labeling that a non-electronic, or passive, implant has not been evaluated for safe use in a magnetic resonance environment, among other clarifications.
      PubDate: Thu, 11 Dec 2014 16:45:00 -050
       
  • FDA Funding Up Slightly In 2015 Funding BiIl, But Device Dollars Stay Flat
    • Abstract: Spending agreement would give FDA about a 1.3 percent increase from fiscal year 2014, in part due to a $25 million one-time increase targeted at the Ebola crisis, but funding for device activities would remain flat at $420.55 million.
      PubDate: Thu, 11 Dec 2014 16:05:01 -050
       
  • ONC Outlines Plan To Expand Telehealth, Mobile Health
    • Abstract: The agency released its five-year strategic plan to encourage broader adoption of health IT, including telehealth and mobile health technologies.
      PubDate: Thu, 11 Dec 2014 12:40:01 -050
       
  • Industry, FDA Start To Settle Into 510(k) Refuse-To-Accept Program
    • Abstract: After a rocky start, the rate of 510(k)s being turned away by FDA before full review under the refuse-to-accept program has steadily declined, and industry expects continued improvement.
      PubDate: Wed, 10 Dec 2014 17:40:00 -050
       
  • Attorneys: ‘Proper Rulemaking’ Better Than Guidance For LDTs
    • Abstract: Industry attorneys speaking at a Food and Drug Law Institute meeting Dec. 8 say FDA should have used the standard rulemaking process, rather than a guidance document, to establish its regulatory framework for laboratory developed tests.
      PubDate: Wed, 10 Dec 2014 17:15:00 -050
       
  • Device Tax Repeal Without Offset May Surface In Tax Bills
    • Abstract: Congress could attach a device tax repeal provision to a tax extenders bill moving through Congress this week, or future tax bills in the next Congress, but no pay-for provisions have been identified.
      PubDate: Tue, 09 Dec 2014 17:20:02 -050
       
  • Surgery Recovery Protocol Promotion Funded By Edwards Foundation
    • Abstract: Following the advice of a multi-stakeholder group that met in June, the Center for Medical Technology Policy and Avalere Health are founding a new forum to improve and accelerate the U.S. adoption of enhanced recovery protocols that can reduce mortality and morbidity following surgery.
      PubDate: Tue, 09 Dec 2014 17:15:00 -050
       
  • FDA Warning Letters: Dec. 2 And 9
    • Abstract: Florida-based IV infusion sets distributors U.S. Infusion failed to notify FDA of at least one device removal order that should have been designated a class II recall, according to a warning letter to the firm, which also details Quality System Regulation and Medical Device Reporting violations.
      PubDate: Tue, 09 Dec 2014 14:25:02 -050
       
  • Stryker's OtisMed Pleads Guilty For Selling FDA-Rejected Cutting Guides
    • Abstract: The unit and its former CEO admitted to selling knee-replacement instruments even after FDA rejected a 510(k), prior to OtisMed being acquired by Stryker in 2009. The legal resolution comes with about $80 million in fines and possible jail time for the former CEO.
      PubDate: Mon, 08 Dec 2014 18:30:01 -050
       
  • Consumer Devices Targeted With Market Research Service
    • Abstract: Finding out what patients expect from new mobile health and sensor-based devices is not a routine market-research challenge. Boston-based Partners Healthcare has launched a new service for companies to help meet this this need.
      PubDate: Mon, 08 Dec 2014 18:10:01 -050
       
  • FDA Recalls List – November 26, 2014
    • Abstract: The agency's Nov. 26 enforcement report includes 47 device recall actions, including 40 class IIs and 7 class IIIs.
      PubDate: Mon, 08 Dec 2014 00:00:55 -050
       
  • Senate Bill Would Exempt Low-Risk Apps From FDA Oversight
    • Abstract: The MEDTECH Act aims to limit FDA’s regulatory oversight of software and mobile apps that carry low-risk for patients, but in a more targeted manner than previous health IT bills that have been introduced in Congress in the past year.
      PubDate: Fri, 05 Dec 2014 11:30:02 -050
       
  • Zimmer Floats Divestments To Win European Approval Of Biomet Acquisition
    • Abstract: Zimmer is negotiating with the European Commission on a strategic divestment strategy that would allow European anti-trust regulators to approve Zimmer’s pending acquisition of Biomet.
      PubDate: Thu, 04 Dec 2014 18:00:01 -050
       
 
 
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