| May 16, 2012 | News for medical technology professionals |
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- MAQUET wins FDA nod for larger volume intra-aortic catheters
The FDA has granted MAQUET Cardiovascular 510(k) clearance for new sizes of its intra-aortic balloon catheters. The MEGA 7.5Fr. 30cc and 40cc catheters are intended to help doctors offer greater hemodynamic support to patients, regardless of their height, as well as allow more blood to be displaced in the aorta during diastole. BeckersASC.com
(5/14)      
 | CAPA Violations Still the Top Issue for FDA: FDA inspectors view a firm's CAPA program as an indicator of how well or how poorly a firm has a handle on its overall operations. Read more... |
- CEO confirms retirement after 20 years of leading Electromed
Robert Hansen, founder, chairman and CEO of Electromed, has announced his retirement after overseeing the respiratory devices firm for 20 years. Hansen formed the company in 1992 with his brother Craig and guided it from the starting concept for its SmartVest airway clearance device to the firm's first sale in the U.S. in 2001 and first global sale in 2006. Electromed has named CIO James Cassidy as interim CEO. MassDevice.com (Boston)
(5/15)
 | Vital supply-chain networking – Join product designers, pharma majors, medical-device OEMs, polymer and clean-room equipment vendors, plastics processors and toolmakers at Plastics in Medical Devices 2012, June 11-13, in Cleveland, Ohio. Hear from 26 speakers, browse dozens of exhibits, attend a technical workshop and more! View the agenda and register! |
| International Developments |  |  |
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| Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. AdvaMed and Eucomed partner on issues of mutual interest. |
- St. Jude gets CE mark for hypertension device
St. Jude Medical's EnligHTN renal denervation device has won CE mark approval, and the company plans to present it in Paris this week at the EuroPCR conference on interventional technologies. The device treats high blood pressure by searing nerves in arteries that supply the kidneys. Bloomberg
(5/15)
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| Industry Service Providers | | |
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- Imaging center positions Toshiba's CT system
Las Vegas-based Steinberg Diagnostic Medical Imaging Center announced the deployment of Toshiba America Medical Systems' Aquilion Prime 160 series in its facility. The 160-slice CT system has several features including the Nema XR 25 Dose Check software and Adaptive Iterative Dose Reduction platform that could be used to perform different imaging tests while limiting the dose of radiation in compliance with the As Low As Reasonably Achievable principle. HealthImaging.com
(5/16)
| Government & Regulatory | | |
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- BPAC to vote on over-the-counter HIV test
The FDA's Blood Products Advisory Committee is considering whether an over-the-counter HIV test should be made available to the public for home use. The FDA panel is expected to weigh the benefit of easy access to the test against the risk of false negatives and false positives, as well as the effect of testing that doesn't involve counseling. MedPage Today (free registration)
(5/14), The Washington Post
(5/15)
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| The Buzz(CORPORATE ANNOUNCEMENTS)
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- Supplier Controls: Regulations and Best Practices Virtual Meeting
Wednesday, June 6
Virtual Conference, 10:00 a.m. - 4:00 p.m. EST
Recent enforcement actions and several product-related tragedies
highlight the risks of inadequate vendor selection and oversight, poor
communication, misunderstanding of regulations and responsibilities, and
a failure to apply the same
risk-based approach to supplied components and services that one
applies to one's own products and processes. This virtual conference
brings together leading authorities from the FDA, industry and critical
component suppliers to discuss strategies and best practices
for instituting and maintaining a robust and responsible supplier
control program.
Visit MTLI online for more information.
- Medical Device Reimbursement Workshop
Tuesday, Oct. 16 – Wednesday, Oct. 17
Sheraton Crystal City, Arlington, Va.
AdvaMed MTLI’s workshop for medical technology reimbursement professionals will provide the road map to successfully navigate the many potential pitfalls. After an overview of reimbursement issues, the workshop will drill down to coding systems, technology assessments and differences in inpatient and outpatient payment systems. Hear from experts on how to negotiate CMS coverage. Learn how to plan for the new health care reform landscape, deal with comparative effectiveness and manage international reimbursement. Visit MTLI online for more information.
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| Position Title | Company Name | Location |
| Regulatory Affairs Manager, R&D | Johnson & Johnson | Fremont, CA |
| Manufacturing Engineer | Spiration, Inc. dba Olympus Respiratory America | Redmond, WA |
| Corporate Compliance Manager | Endologix, Inc. | Irvine, CA |
| Sr. Clinical Research Associate | Endologix, Inc. | Irvine, CA |
| Director, Quality Compliance | American Medical Systems | Minnetonka , MN |
| Principal Regulatory Affairs Specialist-Endo-Santa Rosa CA | Medtronic | Santa Rosa, CA |
| Director, Program Development, Medical Technology Learning Institute | AdvaMed | Washington, DC |
| Regional Sales Director | Regenesis Biomedical, Inc. | Home based office, CA |
| Manager, Regulatory Affairs - 1 of 2 | Johnson & Johnson | Fremont, CA |
| Director of Regulatory Systems; Corporate | Smith & Nephew, Inc. | Andover, MA |
| Director of Regulatory Systems - Corporate | Smith & Nephew, Inc. | Memphis, TN |
| Director of Internal Audit QA/RA - Corporate | Smith & Nephew Inc. | Memphis, TN |
| Vice President – Research, Payment and Health Care Delivery Policy | AdvaMed | Washington, DC |
| Senior Business Systems Analyst - 001324 | Edwards Lifesciences | Irvine, CA |
| Staff Engineer - Cardiac Surgery Systems - 001281 | Edwards Lifesciences | Irvine, CA |
| Technical Supervisor – Heart Valve Therapy Quality - 001374 | Edwards Lifesciences | Irvine, CA |
| Manager, Sales Strategy - Transcatheter Heart Valve - 001277 | Edwards Lifesciences | Irvine, CA |
| Senior Program Manager - Critical Care - 001311 | Edwards Lifesciences | Irvine, CA |
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| Click here to view more job listings. |
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