Reading this on a mobile device? Try our optimized mobile version here: http://r.smartbrief.com/resp/ecdACfbwoceVoKiNHBAL

December 11, 2012News for medical technology professionals

  Top Story 
 
  • Ethicon unit's surgical sealant patch gains FDA approval
    The FDA has granted Ethicon Biosurgery, an Ethicon unit, approval for its EVARREST system designed to help control problematic, surgery-related bleeding. The fibrin sealant patch, which is used with manual compression, has been approved as an ancillary tool to hemostasis for soft tissue bleeding in patients undergoing pelvic surgery and other procedures. BeckersASC.com (12/10) LinkedInFacebookTwitterEmail this Story
Andain Moves Forward with Disposable Insulin Pump
Andain (Beverly Hills, California), a company specializing in technologies for biotech, medical and life sciences fields, reported the development of its miniature fully disposable and programmable insulin pump. The pump is fully disposable and is like a small band-aid sized patch. Find out the details.

  Business & Market Trends 
 
  • Ohio startup seeks funds for device to cut intubation risks
    Miach Medical is seeking to raise money as it develops a third-generation prototype of a device that can be used to reduce intubation complications by equipping feeding and breathing tubes with pressure sensors. "Our goal is really to enhance monitoring of people who require ventilation support or feeding tubes, especially over the long term," company co-founder James Reynolds said. MedCityNews.com (12/10) LinkedInFacebookTwitterEmail this Story
Managing Your FDA Responsibilities and How Medmarc Can Help
Regulatory 360 is a comprehensive series of articles providing an introduction to the world of FDA regulation and presenting framework for its successful navigation. Walk through each stage of the regulatory process, from product development to managing FDA enforcement actions in this complete series. Read More

  International Developments 
 
  • Gore clears EU hurdle for endovascular stent graft
    European regulators have granted W.L. Gore & Associates CE mark approval to market the Excluder AAA endoprosthesis, an endovascular stent graft for treating patients with abdominal aortic aneurysms. The device, designed for patients whose infrarenal aortic inner neck measures 19 to 32 millimeters in diameter, is inserted through a small incision in the leg to close an aneurysm. MassDevice.com (Boston) (12/7) LinkedInFacebookTwitterEmail this Story
  • EU regulators approve urology device from Mauna Kea
    Mauna Kea Technologies has earned CE mark approval in Europe to market Cellvizio UroFlex, which the company says is the first optical biopsy probe intended for urology uses. The device employs the firm's Cellvizio microscopy system, the use of which thus far has been limited to lung and gastrointestinal biopsies, to aid clinicians in diagnosing and monitoring bladder cancer. MedGadget.com (12/7) LinkedInFacebookTwitterEmail this Story
White paper: Supply chain can drive future profits
Of healthcare executives surveyed, 89% say supply chain success is "extremely important" to achieving profitability goals over the next three years. Read the new white paper by Frost & Sullivan, "Why focusing on the supply chain is the key to growing customer relationships and winning in today's healthcare environment." Download it now for free.

  Science & Health 
 
Pay HCPs…Not Penalties!
Receive invoices, process invoices, pay HCP, track payment, report payment, argue with HCP, issue 1099, perform due diligence…start again. Supporting HCP consultants and speakers can be a big task. Watermark has a turnkey solution to meet your needs, support you HCP, and keep you in compliance.

  Emerging Technologies 
The Buzz(CORPORATE ANNOUNCEMENTS)

AssurX helps medical device companies meet tough FDA/regulatory demands. It's critically important to understand and meet the challenges of integrated, global corrective and preventive action (CAPA); complaints management; audits; supplier quality and overall product quality; electronic medical device reporting (eMDR); Learn more here.

Interested in learning more about advertising with SmartBrief? Click here for detailed industry information and media kits.  

  Government & Regulatory 
  • Senators urge device tax implementation delay amid repeal efforts
    A group of senators asked Senate Majority Leader Harry Reid, D-Nev., to defer the start of the 2.3% medical device tax as efforts to repeal the levy continue. In a letter, the group urged Reid to support efforts to make sure the U.S. "maintains its global leadership position in the medical technology industry and keeps good jobs here at home." MassDevice.com (Boston) (12/10) LinkedInFacebookTwitterEmail this Story
FEATURED ARTICLE: Understanding the Power of the Pareto Principle
Here's how the Pareto Principle, also known as the 80-20 rule, can show you which customers you should spend the most time with. Read the article to learn more.

AdvaMed News 
  • 510(k) Submissions Workshop
    Monday, Feb. 25 -- Tuesday, Feb. 26
    Sheraton Crystal City, Arlington, Va.
    This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, 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 review process, and dealing with post-clearance issues. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
Learn more about AdvaMed ->About AdvaMed | Join | Courses | Events | Newsroom

 
Position TitleCompany NameLocation
Payer Relations DirectorSonitus Medical IncSan Mateo, CA
Senior Director, Clinical Programs - Transcatheter Heart ValveEdwards LifesciencesIrvine, CA
Clinical Project ManagerEndologix, Inc.Irvine, CA
Physician Training Program ManagerEndologix, Inc.Irvine, CA
Manager, Grassroots and Member Engagement, Government Affairs AdvaMedWashington, DC
Associate Vice President, Global Strategy and Analysis (Asian Region) AdvaMedWashington, DC
Manager, Regulatory Affairs Sequenom, Inc.San Diego, CA
Clinical DirectorStrykerFreemont, CA
Senior Director, QualityAmerican Medical SystemsMinneapolis, MN
Strategic Sourcing Manager Alpha Source, Inc.Milwaukee, WI
Click here to view more job listings.

  SmartQuote 
Put a grain of boldness into everything you do."
--Baltasar Gracián,
Spanish writer


LinkedInFacebookTwitterEmail this Story

 
 
Subscriber Tools
     
Print friendly format | Web version | Search past news | Archive | Privacy policy

Advertise
Account Director:  Meryl Harold (202) 407-7828
Job Board:  Jackie Basso (202) 407-7871
 
Read more at SmartBrief.com
A powerful website for SmartBrief readers including:
 
 
 Recent AdvaMed SmartBrief Issues:   Lead Editor:  Lisa Gough
     
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
 
 
© 1999-2012 SmartBrief, Inc.® Legal Information