Risk of potentially deadly infection prompts warning over reusable endoscopes | AdvaMed: Indian medtech sector could reach $30B in the next decade | AdvancedCath to be acquired by TE Connectivity in $190M deal
February 20, 2015
ADVAMED SmartBrief
News for medical technology professionals

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Risk of potentially deadly infection prompts warning over reusable endoscopes
The FDA is warning the medical community about the use of devices designed for complex endoscopy procedures following a superbug outbreak affecting seven people, two of whom died, at a hospital in Los Angeles. As many as 179 people may have been exposed to carbapenem-resistant Enterobacteriaceae. The FDA notes that scopes designed to be cleaned and reused are difficult to completely sterilize. Reuters (2/20), Modern Healthcare (tiered subscription model) (2/19), The Hill (2/19)
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5 tips for managing negative online comments
The Internet gives your customers a voice online, but what can you do when that voice is yelling negative comments? With 5 tips, you can learn how to positively respond and help direct the conversation. Read the article and learn the 5 ways to respond positively.

Business & Market TrendsSponsored By
AdvaMed: Indian medtech sector could reach $30B in the next decade
The medtech industry in India could be worth $25 billion to $30 billion over the next 10 years with the proper regulatory structure and appropriate government policies, AdvaMed India Working Group Chairman Sanjay Banerjee said Thursday. The group is also calling for a lower duty on lifesaving devices and is urging India's government to establish an ecosystem for the sector's growth. The Economic Times (India)/Press Trust of India (2/19)
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AdvancedCath to be acquired by TE Connectivity in $190M deal
TE Connectivity, a Swiss maker of connectivity and sensor components for medical devices, said it will pay $190 million to acquire California-based AdvancedCath. The deal is expected to conclude next month. AdvancedCath will be integrated into the medical business unit of TE. FDAnews (2/20)
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Wound care sales drive Q4 revenue growth for Acelity
Texas-based wound care firm Acelity generated $482.7 million in revenue in the quarter ending Dec. 31, compared with $462.4 million in the same period a year earlier. The fourth-quarter growth was driven by increasing sales of the company's advanced wound therapeutics products. MassDevice.com (Boston) (2/19)
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Pulse oximetry devices drive Q4 sales growth for Masimo
Irvine, Calif.-based patient monitoring firm Masimo generated total sales of $161.8 million in the quarter ending Jan. 3, compared with $142.4 million in the same period a year earlier. The fourth-quarter increase was attributed to increased shipments of the company's rainbow Pulse CO-Oximetry and SET pulse oximetry units. MassDevice.com (Boston) (2/19)
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EOS reports Swiss installation of imaging system
A private clinic in Lausanne, Switzerland, that is recognized worldwide for orthopedic surgery has installed a unit of EOS imaging's EOS system, designed for 2D and 3D imaging of orthopedic patients. It is the company's sixth installation of the device in Switzerland. BeckersSpine.com (2/19)
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Building Workplace Trust 2015
Interaction Associates' 6th annual research study tracking trust on the job, Building Workplace Trust, is out, and more than half of employees surveyed give their organizations low marks for trust and leadership. Yet this year's findings again point to how high trust leads to better outcomes and financial results — and even boosts innovation.

Science & HealthSponsored By
BARDA gives Duke, DxTerity $10.4M grant to develop radiation exposure test
The Biomedical Advanced Research and Development Authority awarded a $10.4 million grant to Duke University for its work with DxTerity Diagnostics on a molecular biodosimeter, a genetic test for radiation exposure that the partners said could be useful for triage patients following a mass radiation exposure or nuclear disaster. DxTerity is planning to submit the device for FDA approval in the next three years. GenomeWeb Daily News (free registration) (2/19)
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Report: Worldwide 3D printer technologies market to see sustained growth
A Visiongain report predicts the worldwide market for 3D printer technologies will grow to $2.8 billion by 2019 and continue to rise through 2025. The report cited the wider use of craniomaxillofacial and orthopedic implants, along with technologies such as direct metal laser sintering and selective laser sintering, as some of the factors expected to drive growth. BeckersSpine.com (2/19)
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Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

Emerging TechnologiesSponsored By
Calif. program awards $200,000 in funding for health data initiatives
Five programs aimed at advancing research by leveraging aggregated personal health information received a total of $200,000 from the University of California, San Diego's California Institute for Telecommunications and Information Technology through its Health Data Exploration initiative. PatientsLikeMe Research Director Emil Chiauzzi's project of using wearables and behavior-change programs to treat multiple sclerosis patients is among those that received funding. Other projects that were funded came from Arizona State University, New York University, the Center for Democracy and Technology, and the University of Washington. MobiHealthNews.com (2/19)
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Whitepaper: SDN: How do you get there from here?
Are the growing data needs of mobile, cloud, big data and social threatening today's enterprise networks? Scalable processes, a phased integration approach and the appetite to optimize over time are key components of a modern network. It's how agile organizations prepare for the data needs of tomorrow.
Explore the whitepaper to start down the path toward SDN.

Government & Regulatory
CMS to cover outpatient use of Bard's drug-coated balloon catheter
Procedures using C.R. Bard's Lutonix drug-eluting balloon in an outpatient setting will receive Medicare coverage under a new reimbursement provision released by the CMS. Company officials said the supplemental reimbursement for the device, which obtained FDA premarket approval this month, will begin April 1. MassDevice.com (Boston) (2/19)
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AdvaMed News
IDE Submissions Workshop
Wednesday, Feb. 25
Loews Madison Hotel, Washington, D.C.
During this interactive workshop, FDA staff leaders (invited) and industry experts will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. Topics to be discussed include the components of a successful submission, common errors, the ins and outs of BIMO inspections and more. Learn more.
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PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27
Loews Madison Hotel, Washington, D.C.
Senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staff (invited) will lead professionals through the strategic considerations and practical steps of filing a Premarket Approval. Topics to be discussed include the preparation needed for an adviser panel meeting, tips to prepare for an inspection, how to deal with unexpected clinical outcomes and more. Learn more.
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Who's Hiring?
Position TitleCompany NameLocation
Health Economics & Reimbursement Manager - Transcatheter Heart ValveEdwards LifesciencesIrvine, CA
Senior Associate, Health Economics - Heart Valve TherapyEdwards LifesciencesIrvine, CA
Director of Business Development and MembershipAdvaMedWashington DC, DC
Director of Program DevelopmentAdvaMedWashington DC, DC
Vice-President of Technology and Regulatory AffairsAdvaMedWashington DC, DC
Principal Engineer - Service (US/MI/00/0043/SL) - 14000009CPAbbottChicago, IL
Click here to view more job listings.
Your present circumstances don't determine where you can go; they merely determine where you start."
-- Nido Qubein,
businessman and motivational speaker
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