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The Gray Sheet
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     ISSN (Print) 1530-1214
     Published by Informa plc Homepage  [13 journals]
  • Value Of Exome Sequencing Established By Two Papers In JAMA
    • Abstract: The results of two studies in patients with suspected genetic disorders provides compelling evidence that exome sequencing could become a powerful tool for understanding the genetic origin of rare disorders, leading to better therapy and outcomes for patients.
      PubDate: Mon, 27 Oct 2014 11:00:02 -040
       
  • FDA Recalls List – October 15, 2014
    • Abstract: The agency's Oct. 15 enforcement report includes class I recall actions from Richard-Allan Scientific Company.
      PubDate: Mon, 27 Oct 2014 00:01:37 -040
       
  • FDA Expects Class III Device Imports From China
    • Abstract: As Chinese companies take market share from multinationals in China in some high-risk implantable device categories, FDA's device representative in Beijing says the agency expects to see made-in-China class III devices enter the U.S. Chinese manufacturers, however, face a number of hurdles before this can become reality.
      PubDate: Mon, 27 Oct 2014 00:00:56 -040
       
  • People Briefs: DeSalvo Moves On From HHS ONC; iTraumaCare CEO
    • Abstract: HHS National Coordinator for Health IT DeSalvo leaves post for HHS Ebola response team; Innovative TraumaCare names president and CEO; AzBio’s Joan Koerber-Walker to chair AdvaMed’s State Medical Technology Alliance.
      PubDate: Fri, 24 Oct 2014 16:50:02 -040
       
  • Legacy Devices The Weak Link In Cybersecurity Fence
    • Abstract: Device companies, hospitals and federal agencies are slowly moving towards adoption of a government framework to guide cybersecurity designs and safeguard newer products, but legacy devices are still vulnerable to hackers and may supply entry into secure systems, cybersecurity experts warn at a joint agency summit.
      PubDate: Fri, 24 Oct 2014 15:00:07 -040
       
  • OIG Report Highlights FDA Cybersecurity Problems, Recommends Fixes
    • Abstract: The oversight agency identified several vulnerabilities on FDA’s web site and databases after a cybersecurity breach last year allowed hackers to access data on thousands of FDA clients and raised concern with congressional leaders. FDA says it has fixed the identified issues.
      PubDate: Fri, 24 Oct 2014 15:00:01 -040
       
  • CMS Says No, Again, To Modified Moving Average T-Wave Alternans Testing
    • Abstract: In a new proposed decision memo, CMS says it plans to confirm its existing national non-coverage policy on microvolt T-wave alternans diagnostic testing with the modified moving average method.
      PubDate: Thu, 23 Oct 2014 18:00:06 -040
       
  • No FDA Warning Letters For Device Firms Participating In IMDRF
           Single-Audit Pilot
    • Abstract: Warning letters will not be issued to manufacturers that volunteer to be inspected under the International Medical Device Regulators Forum’s single-audit pilot program unless a significant threat to public health is uncovered, CDRH official Kim Trautman says.
      PubDate: Thu, 23 Oct 2014 18:00:01 -040
       
  • FDA Twitter Guidance Lacks Flexibility, And May Be Unconstitutional,
           Critics Say
    • Abstract: Stakeholders say the agency’s communication requirements for space-limited online platforms are too restricting and violate the First Amendment. Many of them are calling on the agency to withdraw the guidance and try again.
      PubDate: Thu, 23 Oct 2014 17:00:03 -040
       
  • 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
       
 
 
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