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The Gray Sheet
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     ISSN (Print) 1530-1214
     Published by Informa plc Homepage  [13 journals]
  • Court Grants Covidien Injunction Over Ethicon Endo-Surgery’s
           Surgical Shears
    • Abstract: Covidien argues that despite a previous court ruling under appeal that Ethicon infringed on several of Covidien’s patents, the company has continued to use those designs in their line of Harmonic Ace surgical products.
      PubDate: Fri, 17 Oct 2014 16:20:02 -040
  • Claret Targets TAVR Stroke Risk With Sentinel Embolic
           Filter Device
    • Abstract: The company launched the SENTINEL trial in the U.S., the first prospective, randomized, controlled, blinded trial in the U.S. of a cerebral protection device for transcatheter aortic valve replacement.
      PubDate: Fri, 17 Oct 2014 12:00:00 -040
  • FDA Greenlights Vesiflo’s Intraurethral Valve-Pump
    • Abstract: The device was approved for marketing by the agency under a direct de novo petition to treat women who are unable to effectively use bladder muscles required to urinate.
      PubDate: Thu, 16 Oct 2014 17:15:01 -040
  • FDA Approves TriVascular’s CustomSeal
    • Abstract: According to the manufacturer, the new sealing technology shortens endovascular aortic repair times, preserves the aortic neck and allows physicians to customize the seals to the patient.
      PubDate: Thu, 16 Oct 2014 16:55:00 -040
  • Medtronic Pacing Lead Gets FDA Nod For Use With MRI
    • Abstract: The pacing lead which has been in wide use since its introduction more than a decade ago joins Medtronic’s growing line of products approved for use with MRIs.
      PubDate: Thu, 16 Oct 2014 16:30:02 -040
  • 510(k) Data Debated In Comments On FDA Draft Guidance
    • Abstract: Device companies say non-clinical data should be given more prominence in FDA guidance on benefit-risk factors to consider when determining substantial equivalence of 510(k) devices with different technological characteristics from a predicate. But a coalition of consumer groups argues that the draft guidance underplays the need for clinical data.
      PubDate: Thu, 16 Oct 2014 14:00:02 -040
  • St. Jude Plans To Restart Portico TAVR Implants With
           No Device Changes
    • Abstract: The company says it will soon be ready to distribute Portico transcatheter aortic valve replacements again for sale in Europe and for a clinical trial in the U.S. The company had “paused” Portico implants in September following a review of imaging data suggesting a possible defect in valve leaflet mobility, but the company says the device will not need to be modified.
      PubDate: Thu, 16 Oct 2014 13:00:02 -040
  • People Briefs: Angiotech CEO; NeoGenomics COO; Rubicon Genomics VP
    • Abstract: Angiotech appoints John Barr as CEO; NeoGenomics names new chief operating officer; Rubicon Genomics hires VP of product development.
      PubDate: Wed, 15 Oct 2014 16:30:00 -040
  • Two CDC Ebola Tests Authorized, And Industry Is Approached
    • Abstract: As the Ebola crisis continues to worsen in West Africa and has been contracted by two health care workers in the U.S., the agency has cleared two CDC diagnostic tests for detecting the deadly disease under its Emergency Use Authorization pathway. Federal agencies are also talking to industry about possible rapid tests.
      PubDate: Wed, 15 Oct 2014 16:00:03 -040
  • IMDRF Proposes Path To Sharing Device Safety Data Globally
    • Abstract: The International Medical Device Regulators Forum is proposing a new program for national regulatory authorities to exchange information about significant concerns or potential trends with marketed devices that have not yet resulted in recalls or field safety corrective actions.
      PubDate: Wed, 15 Oct 2014 10:00:03 -040
  • FDA Not Asking For 806 Reports For Device Enhancements
    • Abstract: CDRH says its final guidance on distinguishing between recalls and device enhancements is revised from the draft to clarify corrections and removals reporting requirements, among other issues.
      PubDate: Tue, 14 Oct 2014 18:00:02 -040
  • Smith & Nephew Spray-On Wound Therapy Misses Leg Ulcer Endpoint
    • Abstract: A phase III study of the firm's live cell spray-on wound therapy (HP802-247) failed, putting the future of the product, acquired by Smith & Nephew in 2012, in question.
      PubDate: Tue, 14 Oct 2014 17:50:01 -040
  • Medtronic Launches U.S. Trial For Predictive Glucose Monitor-Pump System
    • Abstract: The single-arm pivotal trial is assessing the firm's next-generation diabetes system, which adds predictive algorithm features and a smaller sensor compared to the currently marketed MiniMed 530G low-glucose suspend device, marking another step towards an artificial pancreas, Medtronic says.
      PubDate: Tue, 14 Oct 2014 17:35:00 -040
  • FDA Focuses Workshop On Diabetes Device Software
    • Abstract: The agency's Nov. 13 public workshop on software for diabetes management will focus on diabetes device interoperability and technical considerations for insulin bolus calculator design and use.
      PubDate: Tue, 14 Oct 2014 17:00:23 -040
  • FDA Warning Letters: Oct. 14
    • Abstract: FDA posted three device warning letters on Oct. 14, including one to Zoll's Lifecor division, which makes the LifeVest wearable defibrillator, for quality systems and adverse-event reporting violations.
      PubDate: Tue, 14 Oct 2014 12:15:03 -040
  • Small Uptick In 510(k) Clearances In Fiscal 2014
    • Abstract: FDA cleared 3,103 510(k)s in the fiscal year that ended Sept. 30, averaging about 259 per month, based on a review a FDA’s monthly 510(k) listings. That is up from 2,995 clearances – a 250 per-month average – in FY 2013.
      PubDate: Mon, 13 Oct 2014 18:30:00 -040
  • VisionCare Anticipates Big Boost From Expanded Telescope Implant
    • Abstract: FDA approved VisionCare Ophthalmic Technologies’ Implantable Miniature Telescope to treat macular degeneration in 65- to 74-year-old patients, expanding on the original 75-and-older indication and growing the potential market by about a third.
      PubDate: Mon, 13 Oct 2014 18:10:01 -040
  • Steris Buys Synergy For $1.9 Billion To Create Sterilization Giant
    • Abstract: The deal for UK-based Synergy follows the trend of U.S. companies moving their headquarters to take advantage of more favorable tax rates, but Steris says the deal also makes sense because the companies’ geographies and product ranges are complementary.
      PubDate: Mon, 13 Oct 2014 18:00:00 -040
  • Medtronic Sets Biz Heads For Combined Company; Will Update Structure In
    • Abstract: The device maker named its post-Covidien-acquisition executive leadership team on Oct. 10.
      PubDate: Fri, 10 Oct 2014 16:30:10 -040
  • Bard’s Lutonix Is First FDA-Approved Peripheral
           Drug-Coated Balloon
    • Abstract: Bard is the first drug-coated balloon on the U.S. market, but Medtronic is confident it will catch-up quickly and outpace its rival with more compelling data.
      PubDate: Fri, 10 Oct 2014 16:00:00 -040
  • Exact Sciences Colon Cancer Test Gets Quick Results From CMS
    • Abstract: CMS granted the company a broad-based national coverage policy at breakneck speed and a positive preliminary payment decision to boot for the Cologuard DNA stool test. It is the first national coverage determination resulting from the FDA-CMS parallel review pilot.
      PubDate: Fri, 10 Oct 2014 15:50:03 -040
  • CDRH Releases Draft Flow Cytometric Guidance
    • Abstract: An FDA draft flow cytometric guidance released lays out review concerns for the devices when used for leukocyte immunophenotyping.
      PubDate: Fri, 10 Oct 2014 15:45:03 -040
  • FDA Asks Glucose Monitor Hackers For Gap Analysis Report
    • Abstract: Citizen device hacking group NightScout says the agency wants to allow them to continue their work but wants to see a report on measures to log and report any user confusion, technical problems or adverse events and meet again in three months to discuss. The group, which modifies DexCom glucose receivers to track real time data over the internet, met with FDA Oct. 8.
      PubDate: Fri, 10 Oct 2014 10:45:11 -040
  • MMM Allograft Heart Valves Should Be Class III, FDA Panel Says
    • Abstract: More-than-minimally manipulated allograft heart valves, represented by one cleared product, Cryolife’s CryoValve SG pulmonary heart valve, need to be class III, PMA devices, an FDA advisory panel said Oct. 9.
      PubDate: Thu, 09 Oct 2014 17:35:01 -040
  • Another Advisory Panel For Watchman Yields Another
           Mixed Result
    • Abstract: The market prospects for Boston Scientific’s Watchman left-atrial appendage closure device for stroke remain uncertain following a narrow vote in favor of the device’s risk-benefit profile by FDA’s Circulatory System Devices Advisory Panel even though a majority of the panel did not believe the clinical data proved the device is effective.
      PubDate: Thu, 09 Oct 2014 17:15:01 -040
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