Top Story

• Medtronic gets wider FDA OK for thoracic aorta lesions device
  Medtronic has received expanded premarket approval from the FDA for its Valiant stent graft to be used for treating all descending thoracic aorta lesions, except dissections. Previously, the device, delivered using the Captivia system, was approved only for fusiform aneurysms and saccular aneurysms/penetrating ulcers of the DTA in certain patients. MassDevice.com (Boston) (11/9)     

Siemens Launches Application to Help Deal with Hospital Anxiety

Sometimes patients can develop quite a bit of anxiety when waiting to be treated in the hospital or in their physician’s office. The cold sterile walls could impact patients negatively. It’s a condition that Siemens in partnership with Dream Think Imagine, is seeking to overcome with a newly launched product – ImageScapes. Find out the details.

Business & Market Trends

• Boston Scientific unveils relocation plan in Mass.
  Boston Scientific has announced plans to transfer its headquarters from Natick to Marlboro, Mass., moving about 800 jobs to the new head office beginning next spring. "Consolidating our ... facilities is expected to foster greater collaboration and efficiency, benefiting our employees, our customers and, ultimately, the patients they treat," CEO Mike Mahoney said. Boston Herald (11/9)     

• Mass. spinal implant maker pulls in $11.6 million
  Intrinsic Therapeutics has secured $11.6 million in a round of financing from 11 investors. The Woburn, Mass.-based company, which aims to raise a total of $20 million, is the maker of the Barracaid implantable spinal device designed to treat herniated lumbar discs. Mass High Tech (Boston) (11/9)     

International Developments

• Singapore firm unveils rapid TB detection chip
  Veredus Laboratories has introduced VereMTB, a lab-on-a-chip used to identify different mutations of mycobacterium linked to tuberculosis and nine other clinically relevant mycobacteria. The multiplexed device uses sputum samples coughed up by patients to detect the specific mycobacterium in about three hours. MedGadget.com (11/9)     

• Global Harmonization Task Force to formally end Dec. 31
  The Global Harmonization Task Force will officially cease operations Dec. 31. The task force, established in 1992 to harmonize regional and national medical device regulatory programs, has been replaced with a regulators-only entity, the International Medical Device Regulators Forum, which will carry on some of the GHTF's activities. Clinica (subscription required) (11/9)     

Science & Health

• Vital raises funds to advance bio-artificial liver to Phase III trials
  A regulatory filing disclosed that Vital Therapies has gained $86.1 million since September, bringing the company's total fundraising to about $150 million. The company announced in September that the money will allow it to move its Elad bio-artificial liver to three pivotal Phase III trials in 375 patients with fulminant hepatic failure and acute alcoholic hepatitis. MedCityNews.com (11/9)     

• New blood test helps identify babesiosis in donated blood
  Initial findings from studies of Imugen's experimental blood tests to screen blood donors for babesiosis were presented at this year's AABB Annual Meeting. At the time of the meeting, about 20,000 blood donors had been tested for the disease using a new serologic test method and nucleic acid tests. The testing identified 69 units of blood that were potentially tainted with the disease and were removed from the blood supply. The studies are set to be completed early next year. InfectionControlToday.com (11/8)     

Emerging Technologies

• Plasma preparation device from Cytomedix wins FDA nod
  Cytomedix has obtained 510(k) clearance from the FDA to market its Angel platelet rich plasma technology, which is used to process small blood samples or mixtures of bone marrow aspirate and blood. The system is designed to allow the quick and safe preparation of concentrated plasma in clinical settings. BeckersOrthopedicAndSpine.com (11/8)     

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Hot Topics

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

• Medtronic closes $816M buyout of Chinese orthopedic device firm (American City Business Journals)

• Halt Medical gets FDA OK for device to treat female uterine fibroids (MedCityNews.com)

• Boston Scientific makes inroads in renal denervation market (The Wall Street Journal)

• Medtech trends: The most talked-about device makers in October 2012 (MassDevice.com (Boston))

• Calif. mitral valve implant maker obtains $33.2 million (MassDevice.com (Boston))

• Results based on number of times each story was clicked by readers.

Industry Service Providers

• N.J. hospital adopts GE's breast cancer imaging device
  GE Healthcare has installed its SenoBright system at Camden, N.J.-based Cooper University Hospital, the first area facility to provide the advanced tool for breast cancer scanning. GE said the technology lets doctors run additional tests on the same Senographe device, perform diagnosis with scans that simulate standard mammograms and access results in a similar format. AuntMinnie.com (free registration) (11/12)     

Government & Regulatory

• FDA's device review arm adopts new organizational plan
  The FDA's Center for Devices & Radiological Health has reorganized its structure to include 12 additional branches and two separate review units for surgical devices and neurological/physical medicine technologies. The reorganization took effect at the beginning of November. MassDevice.com (Boston) (11/9)     

AdvaMed News

• Foreign Corrupt Practices Act (FCPA) Seminar for Medical Devices
  Tuesday, Nov. 13
  AdvaMed headquarters, Washington, D.C.
  Learn the latest trends in FCPA enforcement and lessons learned on third-party compliance management. Participate in a panel discussion with industry experts about FCPA risks in Brazil, China and India, and learn how to navigate other global anti-corruption risks. Network with industry experts, receive guidance and obtain up-to-the-minute information on the FCPA. Register for the seminar.     

• Physician Payment Sunshine Act Seminar for Medical Devices
  Wednesday, Nov. 14
  AdvaMed headquarters, Washington, D.C.
  Discuss the implementation issues and challenges of interacting with customers during the statutory review period. Achieve a better understanding of identifying and tracking payments to covered recipients. Obtain step-by-step guidance on classifying payment types such as education expenses, consultant fees, and meals and travel. Learn more about disclosure reporting. Network with industry experts and leaders who will be available to discuss your tracking systems, reporting methods and review processes, and who will provide guidance on potential solutions to your compliance challenges. Register for the seminar.     

Position Title Company Name Location Director of Quality CEA Medical Manufacturing Colorado Springs, CO Senior Director, Quality American Medical Systems Minneapolis, MN Clinical Education Manager, Vascular Therapies Covidien Mansfield, MA Senior/Principal Mechanical Engineer Channel Medsystems San Francisco, CA Director, Global Labeling - 001592 Edwards Lifesciences Irvine, CA Director, Valve Testing - Transcatheter Heart Valve - 001221 Edwards Lifesciences Irvine, CA Compliance Manager, Global Distribution CooperVision, Inc. Rochester, NY or Pleasanton, CA, NY Associate Director, Regulatory Affairs Abbott Laboratories Santa Clara, CA Senior Marketing Communications Manager - Cardiac Surgery Systems - 001558 Edwards Lifesciences Irvine, CA Packaging Engineer/Project Leader Endologix, Inc. Irvine, CA Sr. Manager R & D, Systems Integration Engineering Abbott Laboratories Santa Ana, CA Regulatory Affairs Associate Director Abbott Laboratories Santa Clara, CA Physician Training Program Manager Endologix, Inc. Irvine, CA Director Clinical Research - Capnography Covidien Boulder, CO Field Service Engineer IRIS International, Inc Sacramento, CA Quality Engineer IRIS International, Inc Chatsworth, CA Medical and Clinical Laboratory Technologist IRIS International, Inc Chatsworth, CA Senior Mechanical Engineer IRIS International, Inc Chatsworth, CA Clinical & Customer Care Specialist IRIS International, Inc Los Angeles, CA Developmental Cell Biologist/Biochemist IRIS International, Inc Carlsbad, CA Principal Systems Engineer IRIS International, Inc Chatsworth, CA Field Service Engineer IRIS International, Inc Providence, RI Director Professional Medical Education Covidien Boulder, CO REGULATORY AFFAIRS ENGINEER Welch Allyn Skaneateles, NY

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SmartQuote

I observe the physician with the same diligence as the disease." --John Donne, British poet, satirist, lawyer and cleric