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The Gray Sheet
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     ISSN (Print) 1530-1214
     Published by Informa plc Homepage  [13 journals]
  • Consistency Among CDRH Review Divisions Improves, But Industry Wants More
    • Abstract: A new report from the California Healthcare Institute shows a positive convergence of performance goal achievement among FDA’s review divisions, but the biomedical industry group thinks more policy focus on improving uniformity might be warranted.
      PubDate: Thu, 23 Oct 2014 11:25:02 -040
       
  • S-ICD Sales Exceeding Expectations, Boston Scientific Reports
    • Abstract: The company said when it launched that it expected S-ICD to be a major growth driver, and that appears to be working out so far. The company now expects the leadless implantable defibrillator to bring in $100 million in revenue this year.
      PubDate: Wed, 22 Oct 2014 17:35:02 -040
       
  • New EC Leadership Backpedals: EU Device Oversight Will Stay In Health
           Division
    • Abstract: The incoming president of the European Commission has reversed a decision that would have moved EU oversight of medical device and drug policy issues from the health division to the markets/industry division following criticism from lawmakers and health care advocates.
      PubDate: Wed, 22 Oct 2014 17:30:04 -040
       
  • Sorin Gains Distribution Rights, Minority Stake In Respicardia’s
           remedē Sleep Apnea Device
    • Abstract: Sorin’s $20 million investment will help Respicardia continue the U.S. pivotal trial of the remedē implantable phrenic nerve stimulator and give Sorin exclusive rights to distribute the device in select European countries, wherethe device has a CE mark, but has yet to be launched.
      PubDate: Tue, 21 Oct 2014 18:35:16 -040
       
  • X-spine Steps Into Biologics Arena
    • Abstract: The spine device company says it is branching out from its focus on fixation products and delving into biologics and interventional treatments.
      PubDate: Tue, 21 Oct 2014 18:35:03 -040
       
  • Boston Scientific Gets Nod For CoverEdge Spine Cord
           Stim Leads
    • Abstract: The company says by doubling the number of contacts on its surgical leads patients will benefit from wider coverage and better targeting of chronic pain signals in the spine.
      PubDate: Tue, 21 Oct 2014 17:35:03 -040
       
  • U.S. Government Engages Dx Firms For Rapid, Field-Based Ebola Test
    • Abstract: Multiple companies are receiving funding or are in discussions with federal agencies about development of rapid assays for Ebola that can be used by patients and health care workers in the field, according to a top official at the National Institute of Allergy and Infectious Diseases, in an interview with "The Gray Sheet."
      PubDate: Tue, 21 Oct 2014 16:00:01 -040
       
  • Valeant On Stronger Ground As It Readies For Allergan Showdown
    • Abstract: The Canadian pharma reported a strong third quarter and an improved debt position as it prepares for the December meeting with Allergan shareholders that could result in an ousting of the Botox-maker’s board.
      PubDate: Tue, 21 Oct 2014 15:10:03 -040
       
  • FDA Approves Dexcom Share To Remotely Track Blood
           Glucose
    • Abstract: While the device lets parents and caregivers access blood glucose data remotely, a group who currently hacks DexCom's system to improve its data mobility says the newly approved Share doesn’t go far enough in providing mobility and that it costs too much.
      PubDate: Mon, 20 Oct 2014 18:30:00 -040
       
  • Boston Scientific Launches Stent Trial In Underserved Populations
    • Abstract: PLATINUM Diversity trial will examine Promus Premier stent in women and people of color, populations that have been underrepresented in previous trials. The trial coincides with the company’s Close the Gap education initiative and FDA’s efforts to promote inclusion of demographics subgroups in clinical trials.
      PubDate: Mon, 20 Oct 2014 18:20:00 -040
       
  • Hospital Glucose Meter Standard Not Recognized By FDA, Agency Clarifies
    • Abstract: FDA says a 2013 Clinical and Laboratory Standards Institute standard for hospital glucose testing was never meant to be recognized by the agency, despite a July listing.
      PubDate: Mon, 20 Oct 2014 17:05:04 -040
       
  • Precision Spine’s Vault-C Cervical Device
           Launches in U.S.
    • Abstract: The company has begun marketing its device to treat degenerative disc disease in the U.S., after getting 510(k) clearance last year.
      PubDate: Mon, 20 Oct 2014 00:01:28 -040
       
  • Indian Government Supports Country-Specific Device Labels
    • Abstract: New rules from the government of India allow India-specific labels to be affixed on to devices after they are imported into the country, a policy device firms had pushed for.
      PubDate: Mon, 20 Oct 2014 00:01:11 -040
       
  • FDA Recalls List – October 7, 2014
    • Abstract: The agency's Oct. 7 enforcement report includes a class I action from Teleflex Medical.
      PubDate: Mon, 20 Oct 2014 00:00:04 -040
       
  • 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
           Technology
    • 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
       
 
 
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