| August 28, 2012 | News for medical technology professionals |
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- Becton announces buyout of Sirigen
Becton Dickinson & Co. has agreed to pay an undisclosed sum to acquire British medical device maker Sirigen Group. The deal will give Becton access to Sirigen's polymer technology, which aids in the development of medical dyes that are substantially brighter than traditional dyes. CNBC/The Associated Press
(8/27)
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| International Developments |  |  |
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- Global spinal surgery device market predicted to reach $14.8B
A MarketsandMarkets report predicts that the global market for spinal surgery devices will grow to $14.8 billion in five years, driven by advances in technology and an aging population. The report, however, notes that factors such as the need to cut costs, sluggish economy and reimbursement policy changes could impede growth. MedCityNews.com
(8/27)
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| Emerging Technologies |  |  |
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- Medtronic's device to treat atrial fibrillation gets FDA OK
The FDA has approved Medtronic's Arctic Front Advance Cardiac Cryoballoon, which is used to treat patients with paroxysmal atrial fibrillation less invasively. The device, which uses the EvenCool Cryo system to release coolant inside the balloon, has been linked to faster procedure times compared with radiofrequency ablation. Fox Business
(8/24)
| Government & Regulatory |  |  |
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- Qui tam suit from inside FDA raises confidentiality concerns
Reports that FDA employees had filed a whistle-blower lawsuit raise concerns about the confidentiality of information submitted by medical device makers for review, James R. Phelps writes in this post at the FDA Law Blog. The suit was not pursued, but "if such a suit were to proceed, then confidence in FDA's ability to manage valuable and confidential information will be greatly compromised," Phelps writes. FDALawBlog.net
(8/26)
- Advertising and Promotion of Medical Devices
Tuesday, Nov. 6 – Wednesday, Nov. 7 Washington Marriott at Metro Center, Washington, D.C. Learn how to communicate your value without overstepping legal and regulatory boundaries. FDA staff, medical technology company leaders, legal experts and public affairs professionals will clarify the boundaries and the best practices for navigating these challenges. Our dialogue will include FDA and FTC regulations, risk management, the limits on label and advertising content, off-label use information, social media opportunities and challenges, promotion to providers and direct-to-consumer communications. Register for the workshop.
- 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.
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| Position Title | Company Name | Location |
| Manager, Reimbursement and Outcome Planning | Olympus America Inc. | Center Valley, PA |
| Sr. Quality Engineer - New Product Development | Endologix, Inc. | Irvine, CA |
| Technical Manufacturing Supervisor (2nd Shift) | Endologix, Inc. | Irvine, CA |
| Packaging Engineer/Project Leader | Endologix, Inc. | Irvine, CA |
| Clinical Project Manager | Endologix, Inc. | Irvine, CA |
| Director, Global Labeling - 001592 | Edwards Lifesciences | Irvine, CA |
| Asia Business Consulting: Senior Associate/ Director | Pacific Bridge Medical | Bethesda, MD |
| Regional Sales Director | Regenesis Biomedical, Inc. | Baltimore/Washington DC Area, MD |
| Product Manager- Networking Event | Olympus | Southborough, MA |
| Director, Valve Testing - Transcatheter Heart Valve - 001221 | Edwards Lifesciences | Irvine, CA |
| Director of Product Management - Medical | Excelitas Technologies | Nationwide, United States |
| Communications Manager | Stryker | Kalamazoo, MI |
| Senior Global Product Manager, Tissue Programs, New Product Development | Edwards Lifesciences | Irvine, CA |
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