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  The Gray Sheet
   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1214
   Published by Informa plc Homepage  [14 journals]
  • Warning Letter Close-Outs – July 2015
    • Abstract: Ten FDA close-out letters were released in June.
      PubDate: Fri, 31 Jul 2015 15:30:02 -040
  • Device Submission User Fee Rates To Rise In FY 2016
    • Abstract: FDA user fees for individual device submissions will increase by about 4 percent beginning Oct. 1, and the annual registration fee will rise by 5.5 percent in FY 2016.
      PubDate: Fri, 31 Jul 2015 15:00:01 -040
  • Vendor Inspections Hold Up Wright's Augment Graft
    • Abstract: Wright received an "approvable" letter from FDA about nine months ago for its Augment biologic-device bone graft, but the approval is delayed as the agency performs multiple inspections and has issued two Form-483s to a component supplier for the product.
      PubDate: Thu, 30 Jul 2015 18:10:00 -040
  • Current Fetal Ultrasound Practices Could Increase Risks, Studies Suggest
    • Abstract: A sharp increase in the use of fetal ultrasounds in recent years in women with healthy pregnancies from an average of 2 scans to 5 scans per pregnancy and recent warnings from medical societies could prompt FDA to look more closely at possible risks to the fetus from ultrasound.
      PubDate: Thu, 30 Jul 2015 16:00:01 -040
  • GI Dynamics Terminates Pivotal Endobarrier Trial
           Based On Safety Data
    • Abstract: FDA and the company could not come up with a plan to continue the ENDO study for GI's device targeting obese patients with diabetes in response to higher-than-anticipated rates of liver infection. The company suggests, however, that development of the device will continue.
      PubDate: Thu, 30 Jul 2015 12:40:02 -040
  • Edwards Pushes Ahead On Early Than Expected Sapien 3
    • Abstract: Up until shortly before the FDA approved Sapien 3, Edwards did not expect the approval to come until later this year, so the U.S. rollout is still expected to be complete by year's end.
      PubDate: Wed, 29 Jul 2015 21:15:01 -040
  • Robotic Surgery Devices Are Tools, Not Instruments, Say Physicians,
    • Abstract: Industry and physicians speaking at a two-day FDA meeting on robotically-assisted surgical devices emphasized the need to regulate the technology as any other surgical tool, with Intuitive Surgical proposing a new regulatory paradigm to accomplish that. Meanwhile, the company and surgeons differ on who should be leading physician training on the robotic systems.
      PubDate: Wed, 29 Jul 2015 19:00:02 -040
  • Health Spending Growth Sees 5.5 Percent Rise After Years Of Recession Lows
    • Abstract: National health care spending grew 5.5 percent between 2013 and 2014 after years of more modest increases linked to the recession, CMS actuaries said. Also, DME growth dropped from 4.2 to 2.9 percent last year, but will rise by 5.1 percent by the end of 2015, according to the Medicare agency.
      PubDate: Tue, 28 Jul 2015 18:15:10 -040
  • NuVasive Settles With DOJ On Medicare Fraud Charges
    • Abstract: The spine device firm announced a definitive settlement with the Department of Justice, with a fine of $13.5 million, plus fees and accrued interest
      PubDate: Tue, 28 Jul 2015 16:55:05 -040
  • Obesity Devices Day: FDA OK's ReShape Dual Balloon;
           PMA Submitted For Aspiration Therapy
    • Abstract: It was a banner day for minimally invasive weight-loss devices July 28. FDA approved ReShape Medical's intragastric balloon and, on the same day, Aspire Bariatrics reached a key milestone with the PMA submission for its AspireAssist aspiration therapy system for obesity.
      PubDate: Tue, 28 Jul 2015 16:45:01 -040
  • Warning Letter Roundup & Recap – July 28, 2015
    • Abstract: No device warning letters were released by FDA this week.
      PubDate: Tue, 28 Jul 2015 10:55:00 -040
  • FDA Biomarker Program Needs Overhaul, Genentech Says
    • Abstract: Outside experts could provide 'consultation and advice' to sponsors developing qualification plans and to FDA in evaluating qualification submissions.
      PubDate: Mon, 27 Jul 2015 13:00:01 -040
  • Industry Push For Global GCPs, Final Rule Before FDA Completes Foreign
           Study Guidance
    • Abstract: Medical device makers are concerned about a lack of globally harmonized standards for good clinical practices, which they say could cause problems for a guidance FDA has drafted on studies conducted outside the U.S.
      PubDate: Mon, 27 Jul 2015 10:00:00 -040
  • FDA, CDRH Receive Slight Boosts From Senate In 2016 Funding Bill
    • Abstract: The Senate Appropriations Committee approved $10 million more in FDA funding and $1 million more in CDRH funding in 2016 than House Appropriators did in a July 16 markup, and $2 million for a Precision Medicine Initiative next year, falling far short of the President’s $10 million request for the initiative.
      PubDate: Mon, 27 Jul 2015 00:03:02 -040
  • Device Week Podcast - Episode 7
    • Abstract: This week, "Gray Sheet" journalists discuss St. Jude Medical’s blockbuster Thoratec acquisition, with some historical context on ventricular assist devices and a Dr Oz connection; we also talk about developments on Capitol Hill and an industry request for risk classifications for clinical decision support software.
      PubDate: Fri, 24 Jul 2015 17:15:01 -040
  • Foreign Industry Unites Against Annual Japan Price Cuts
    • Abstract: Major groups representing the foreign innovation-based pharma and medtech industries in Japan have come out in strong united opposition to a proposal to adopt annual, rather than biennial, reimbursement price cuts, warning this could adversely affect investment and the provision of healthcare.
      PubDate: Fri, 24 Jul 2015 14:00:01 -040
  • Medicare Advisors Lukewarm On Lower Extremity PAD Intervention Evidence
    • Abstract: The Medicare Evidence Development and Coverage Advisory Committee voted low to moderate support for the scientific evidence backing endovascular and other interventions to treat lower extremity peripheral artery disease.
      PubDate: Thu, 23 Jul 2015 22:00:01 -040
  • Boston Sci Says It Will Be Careful About Resorbable Scaffold Investment
    • Abstract: The company announced July 20 the start of its 30-patient, single-arm FAST study assessing its everolimus-eluting scaffold system, but executives says Boston Scientific will be closely considering whether the system warrants long-term investment, considering the promise of its Synergy stent.
      PubDate: Thu, 23 Jul 2015 21:50:01 -040
  • Group Calls For Classification Clarity Before Clinical-Decision Support
    • Abstract: The Clinical Device Support (CDS) Coalition wrote to top FDA officials recently asking the agency to provide clarification on how it wants to classify CDS applications through a "master plan." The industry group says the current de novo process used for such software is creating confusion, burdens and barriers to new applications coming to market.
      PubDate: Thu, 23 Jul 2015 17:30:00 -040
  • St. Jude Shoots For 2016 With PFO Closure Device For Stroke
    • Abstract: Slam-dunk data supporting patent foramen ovale closure to prevent stroke has been elusive, but St. Jude now says discussions with FDA suggest that its device could be approved in 2016 following a panel meeting.
      PubDate: Wed, 22 Jul 2015 17:05:02 -040
  • VADs Set To Enter Big Leagues With St. Jude's Plan To Acquire Thoratec
    • Abstract: St. Jude Medical says it will pay $3.4 billion to own ventricular-assist device leader Thoratec, pointing to significant synergies in the heart failure and interventional cardiology markets.
      PubDate: Wed, 22 Jul 2015 16:40:00 -040
  • After Long Decline, Industry Spending On CME Programs Rises Again
    • Abstract: Drug and device companies increased funding for continuing medical education programs by 2.4 percent in 2014 to $675.9 million; support had declined steadily since peaking in 2007.
      PubDate: Wed, 22 Jul 2015 10:00:02 -040
  • Bid To Make R&D Tax Credit Permanent Fails In Senate Committee;
           Finance OKs 2-Year Extension
    • Abstract: Senators eager to make a popular, two-year-long R&D tax credit permanent were thwarted again July 21 when the Finance Panel approved a package of temporary tax-extenders.
      PubDate: Tue, 21 Jul 2015 18:00:11 -040
  • Warning Letter Roundup & Recap – July 21, 2015
    • Abstract: FDA outlines quality systems, premarket and Medical Device Reporting violations for two CR Bard facilities in a single missive in the only device warning letter listed by FDA this week.
      PubDate: Tue, 21 Jul 2015 18:00:02 -040
  • Abbott Submits PMA For Absorb Bioresorbable Scaffold
    • Abstract: The firm's FDA submission for the first-in-class bioresorbable vascular scaffold was completed in the second quarter, a spokesman said. That appears to be ahead of a prior estimate to submit by the end of 2015.
      PubDate: Tue, 21 Jul 2015 16:25:02 -040
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