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February 18, 2013News for medical technology professionals

  Top Story 
  • Lombard Medical gets FDA OK for aneurysm device
    The FDA has granted Lombard Medical Technologies approval for use of its Aorfix stent in treating abdominal aortic aneurysm in patients with up to 90 degrees of angulation at the neck of the aneurysm. The approval gives Lombard access to the U.S. endovascular repair market, which represents over half of the global market. Reuters (2/15) LinkedInFacebookTwitterEmail this Story
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  Business & Market Trends 
  • Boston Scientific takes part in $27M funding round for BaroNova
    BaroNova has obtained $27.3 million in a round of Series C financing that included medical device giant Boston Scientific. The Goleta, Calif.-based company, which is working on a minimally invasive weight-loss device, will use the money to conduct a pivotal trial to support its pursuit for U.S. and European regulatory approvals. (Boston) (2/15) LinkedInFacebookTwitterEmail this Story
Plastics News is taking its Plastics in Medical Devices 2013 conference to Boston
The 4th annual event will be held May 13-15 at the Waltham Westin. Attend to engage with each part of the supply chain – from device designers and materials suppliers to plastics processors, machinery makers and device OEMs. Register by April 15 to save $100.
  International Developments 
  • EU regulators approve ApiFix's scoliosis correction device
    Regulators in Europe have given ApiFix CE mark approval to market a device designed to treat patients with adolescent idiopathic scoliosis. The implantable device has been shown in a pilot clinical study in Europe to be safe and effective in correcting the curvature in participating patients, ApiFix CEO Uri Arnin said. (2/15) LinkedInFacebookTwitterEmail this Story
How to Address 10 Common Pains in Dossier Management & Product Registration
While the process for obtaining a device clearance or premarket approval (PMA) in the United States is not the same as applying for a Shonin in Japan or a CE mark in Europe, there are many similarities, especially when it comes to dossier management pains and challenges.
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  Science & Health 
  • Postmarket trial begins for ReCor's hypertension device
    ReCor Medical has begun patient enrollment for a postmarket trial of the company's Paradise renal denervation technology, a next-generation device that uses ultrasound to treat resistant hypertension. Patients in the Netherlands were the first to be enrolled in the study, which aims to enlist 50 patients. (Boston) (2/15) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  Hot Topics 

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Industry Service Providers 
  • Medtech boot camp for military veterans kicks off
    The Massachusetts Technology Veterans Program kicked off last week with a boot camp that began a year-long program for military veterans that gives them internships and coaching from mentors in the medical device industry. The program, which includes mentors from companies such as Medtronic, Abiomed, Boston Scientific and Haemonetics, is intended to help prepare participating veterans for a career in the medtech sector. American City Business Journals/Boston/BioFlash blog (2/14) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • FDA gives Dako nod on rapid cancer diagnostic test
    Dako has received approval from the FDA to market its HER2 IQFISH pharmDx test, which is used to cut the turnaround time for cancer diagnosis from the industry standard of two days to three-and-a-half hours. The test, which identifies the HER2 gene in breast cancer diagnosis, is the first FDA-approved test that works with Dako's IQISH system, the company said. GenomeWeb Daily News (free registration) (2/15) LinkedInFacebookTwitterEmail this Story
  • FDA clearance sought for Affymetrix's cytogenetics platform
    Affymetrix has submitted an FDA clearance application for its CytoScan cytogenetics platform in hopes of expanding into clinical diagnostics, translational medicine and applied markets, a company official said. The company said earlier that it anticipates releasing an FDA-cleared cytogenetics product by midyear, but it has not disclosed when it expects the FDA OK for CytoScan. GenomeWeb Daily News (free registration) (2/15) LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • Medical Device Reimbursement Workshop
    Tuesday, Feb. 26 – Wednesday, Feb. 27
    Sheraton Crystal City, Arlington, Va.
    Learn from medical device reimbursement experts what new legislative and regulatory changes apply to the area of reimbursement; the key reimbursement issues for medical technology; how Medicare coverage is determined at the national and local levels; the role of MEDCAC; why technology assessments are important; how clinical trial results impact payers; what you need to do to keep up on new reimbursement developments relevant to your products; how to maintain a nimble, dynamic, effective, ongoing reimbursement program; what to do when reimbursement is denied; drill-down coding systems; differences in inpatient and outpatient payment systems; physician fee schedules and product design; how to negotiate CMS coverage; how to plan for the new health care reform landscape deal with comparative effectiveness; and how to manage international reimbursement. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Premarket Approval (PMA) Submissions Workshop
    Thursday, Feb. 28 – Friday, March 1
    Sheraton Crystal City, Arlington, Va.
    Senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead professionals through the strategic considerations and practical steps of filing a premarket approval, illustrated with real-world case studies. Topics include: the new acceptance and filing review guidance document; the eCopy Program for Medical Device Submissions; strategy development and evidence requirements; productive meetings with the FDA; the mechanics of premarket approval submission development; advisory panels; inspectional activity; and conditions of approval studies. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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You will become as small as your controlling desire; as great as your dominant aspiration."
--James Allen,
British author

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