| November 20, 2012 | News for medical technology professionals |
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| Business & Market Trends | | |
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- Diagnostics maker pulls in $9M
Metamark Genetics said in a regulatory filing that it secured $9 million as part of a $13 million Series B funding round. The company plans to use the proceeds to complete final clinical validation of two prognostic tests for prostate cancer. Mass High Tech (Boston)
(11/16)      
| International Developments | | |
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- St. Jude wins approval for Portico heart valve in Europe
St. Jude Medical has obtained CE mark approval to market its Portico transcatheter aortic valve implant in Europe. The device was created to prevent paravalvular leaks and, according to a company press release, it is the “only approved transcatheter valve that can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system.” MedCityNews.com
(11/19)
| Science & Health | | |
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- Medtronic enrolls first U.S. patient in global heart valve trial
Medtronic has enrolled the first lower-risk patient from the U.S. in a worldwide clinical study of its CoreValve transcatheter aortic valve implantation device. The study, which will involve about 2,500 patients, aims to compare the use of the CoreValve TAVI device with surgical valve replacement in aortic stenosis patients who are at intermediate risk for open-heart procedures. MassDevice.com (Boston)
(11/19)
| Emerging Technologies | | |
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- Compact microchip uses minimal power to capture ECG, EEG signals
U.S. engineers have created a microchip about the size of a postage stamp that uses minimal external power to capture ECG and EEG signals. The technology, which produces its electric current from radio waves captured from nearby devices, could provide a cheaper and more compact alternative to similar tools used in monitoring vital signs continuously. MedGadget.com
(11/16)
| Industry Service Providers | | |
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| Government & Regulatory | | |
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- FDA continues to wrestle with personnel challenges, report says
The FDA has made strides in strengthening its scientific workforce since 2007 through efforts such as enhanced training for medical device reviewers, but it still faces management and staffing challenges, says a Partnership for Public Service report set to be released today. The report urges the FDA to devise targeted recruitment programs, among other recommendations. The Washington Post
(11/19)
- FDA issues approvable letter to Dune for breast cancer device
The FDA has issued an approvable letter to Dune Medical Devices for the company's Margin Probe system, which is used with other techniques to detect whether tumors in breast cancer patients have been completely removed. That brings the company closer to obtaining premarket approval for the device, which already has marketing clearance in Europe and Israel. Mass High Tech (Boston)
(11/19)
- Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. 27
Sheraton Crystal City, Arlington, Va.
MTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE application, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices. Visit MTLI online for more information.
- Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 28 – Friday, March 1
Sheraton Crystal City, Arlington, Va.
Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. Visit MTLI online for more information.
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| Position Title | Company Name | Location |
| Director of Quality | CEA Medical Manufacturing | Colorado Springs, CO |
| Clinical Education Manager, Vascular Therapies | Covidien | Mansfield, MA |
| Manager, Grassroots and Member Engagement, Government Affairs | AdvaMed | Washington, DC |
| Associate Vice President, Global Strategy and Analysis (Asian Region) | AdvaMed | Washington, DC |
| Manager, Regulatory Affairs | Sequenom, Inc. | San Diego, CA |
| 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 |
| Regulatory Affairs Associate Director | Abbott Laboratories | Santa Clara, CA |
| REGULATORY AFFAIRS ENGINEER | Welch Allyn | Skaneateles, NY |
| Senior Director, Quality | American Medical Systems | Minneapolis, MN |
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