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January 31, 2013News for medical technology professionals

  Top Story 
  • Thermo reportedly explores takeover bid for Life Technologies
    Thermo Fisher Scientific is weighing a possible bid to acquire Life Technologies, a maker of biomedical laboratory instruments, sources say. The deal, if completed, would represent Thermo Fisher's biggest acquisition since Thermo Electron and Fisher Scientific International merged seven years ago to form Thermo Fischer, according to this article. Reuters (1/30) LinkedInFacebookTwitterEmail this Story
 Free White Paper: FDA: 21 CFR PART 11 & EU: GMP - ANNEX 11
The EU's Annex 11 focuses on risk management throughout the entire lifecycle of the computerized GMP process. Review this comparison between the requirements set forth in 21 CFR Part 11 and in Annex 11, along with Pilgrim Software's own interpretation of the requirements. DOWNLOAD THIS PAPER TODAY.

  Business & Market Trends 
  International Developments 
  • Eucomed comments on EU medtech scrutiny in position paper
    Eucomed calls the scrutiny procedures in the European Commission's proposed regulation of medical devices "inappropriate," saying the regulation will not help ensure device safety and will instead create a false sense of security while duplicating regulatory efforts and creating financial burdens for new companies. The proposal would create a Medical Device Co-ordination Group to review products and clinical trial evidence. Eucomed advocates an alternative "systematic authority control procedure on notified bodies and clinical review that go beyond the current proposed measures," including measures to keep stakeholders involved in the process. Clinica (subscription required) (1/31) LinkedInFacebookTwitterEmail this Story
  • Minn. medical device startup secures $6.125 million in Malaysia
    Mardil Medical is receiving $6.125 million from Agensi Inovasi Malaysia, according to the Minnesota-based startup that has developed what it says is the first mitral valve implant. "[S]trategic financing from Asia and elsewhere may be what it takes to secure American leadership for many pre-revenue stage life science companies," CEO Jim Buck said. (1/30) LinkedInFacebookTwitterEmail this Story
  Industry Insight 

  Science & Health 
  • Midstage trial begins for Svelte Medical's drug-eluting stent
    Svelte Medical has begun a Phase II clinical study comparing its bioabsorbable drug-eluting stent with the polymer-based Resolute stent from Medtronic. The trial aims to enroll 159 patients from 20 clinical locations in Brazil and Europe and will involve six-month clinical and angiographic follow-up, plus a five-year monitoring period. (Boston) (1/30) LinkedInFacebookTwitterEmail this Story
  • Firms ally to develop Alzheimer's disease diagnostic test
    Amorfix Life Sciences will work with QPS Holdings to develop and validate the EP-AD test, with the goal of seeking FDA approval for diagnosing Alzheimer's disease early using a biomarker that could aid in clinical trials. The companies' research will include the collection and analysis of cerebral spinal fluid from patients at different stages of the condition. Pharmaceutical Business Review Online (1/30) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Medtronic debuts MRI-safe neurostimulation devices in Europe
    Medtronic is launching in Europe its MRI-compatible neurostimulation devices, which include the RestoreAdvanced SureScan MRI, PrimeAdvanced SureScan MRI, RestoreSensor SureScan MRI and RestoreUltra SureScan MRI. The products, which work with the firm's Vectris SureScan MRI leads, allow patients implanted with the devices to receive whole-body MRI scans safely. (1/30) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • 510(k) Submissions Workshop
    Monday, Feb. 25 -- Tuesday, Feb. 26
    Sheraton Crystal City, Arlington, Va.
    Join quality and regulatory professionals at this interactive 510(k) workshop. Industry experts and key personnel from the FDA CDRH and CBER 510(k) staff inform you in detail on current FDA updates to the 510(k) process (eCopy Program for Medical Device Submissions); a step-by-step walk-through of the 510(k) regulatory guidelines; 510(k) practical steps and strategic considerations for determining a product's regulatory route to market; identifying a predicate device; planning and assembling a 510(k) submission; interacting with the FDA during the 510(k) review process; 510(k) post-clearance issues; and the Refuse to Accept Policy for 510(k)s.  Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Investigational Device Exemption (IDE) Submissions Workshop
    Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    FDA staff leaders and industry experts at this interactive workshop will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption is required; how to compile effective investigational device exemption applications; the eCopy Program for Medical Device Submissions; the rules governing clinical studies and human subject protection; Institutional Review Boards; types of pre- investigational device exemption meetings and communications; early/expanded access; foreign studies and export; and reimbursement for investigational devices. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
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Director of Clinical AffairsEndologixIrvine, CA
Sr. Clinical Research AssociateEndologix, Inc.Irvine, CA
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Any workout which does not involve a certain minimum of danger or responsibility does not improve the body -- it just wears it out."
--Norman Mailer,
American writer

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