| July 6, 2012 | News for medical technology professionals |
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| Business & Market Trends | | |
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- Mass. endoscopy device maker obtains $1.25 million
Beacon Endoscopic has pulled in $1.25 million with an equity offering targeted at $4 million. The funding comes a month after the company announced the U.S. release of the Beacon Needle eXchange System, a device used in endoscopic ultrasounds that features removable needles and an automatic sheath for user protection. Mass High Tech (Boston)
(7/5)      
- Ariz. startup gets $1M for wound treatment system
 Harmonic Cold Plasma, maker of the Wound Care System 1000 that uses cold plasma technology to treat and protect difficult wounds and surgical sites from infection, has raised $1 million. The startup reportedly has wrapped up animal trials for the device, and a commercial version is being developed for which it will apply for U.S. and European regulatory approvals. MedCityNews.com
(7/5)
- Former Bayer exec joins Kinetic Concepts
Kinetic Concepts, which specializes in wound care devices, has tapped Mike Mathews to serve as senior vice president of its operations in Europe, Africa and Asia. Mathews most recently served as senior vice president and region head of North America for Bayer Health Care's diabetes care division. Clinica (subscription required)
(7/5)
| International Developments | | |
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- Sectra lands supply deal in Russia for visualization table
Sectra has struck a deal to supply St. Petersburg Scientific Practical Centre for Oncology in Russia with its Sectra Visualization Table. The device, which gives doctors access to manipulatable 3D images produced by MRI and CT scanners, will be used by the hospital's oncologists for surgery and treatment planning. HealthImaging.com
(7/5)
| Science & Health | | |
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- U.S. Army funds development of rapid blood-screening test
The U.S. Army has awarded Canadian company MedMira a contract worth more than $4 million for the development of its Multiplo Rapid HBV/HIV/HCV Antibody Test. The test is used for quick testing of blood for HIV and hepatitis B and C before emergency transfusions. The U.S. Army will also shoulder development costs and related fees for getting FDA pre-market approval for the test. United Press International
(7/5)
| Emerging Technologies | | |
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| Industry Service Providers | | |
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| Government & Regulatory | | |
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- Sanovas readies 510(k) application for lung surgery device
Sanovas is preparing to submit to the FDA a 510(k) application for its Vas Zeppelin Clear Vessel Technology. The device, which the company hopes to have ready for commercial release as early as January, is designed to improve imaging, access, diagnosis and monitoring during micro-invasive lung procedures. MedCityNews.com
(7/5)
- Join the AdvaMed-MTLI LinkedIn group!
 Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page.
- 510(k) Submissions Workshop
Monday, Oct. 15 – Tuesday, Oct. 16
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.
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| Position Title | Company Name | Location |
| Manager, Learning Content Infrastructure 001493 | Edwards Lifesciences | Irvine, CA |
| Distributed Sales Operations & Relationship Manager 001373 | Edwards Lifesciences | Irvine, CA |
| Director, Public Affairs | AdvaMed | Washington, DC |
| Senior Counsel - Regulatory Law | Johnson & Johnson | New Brunswick, NJ |
| Product Manager | SentreHEART, Inc. | Redwood City, CA |
| Clinical Field Associate | SentreHEART, Inc. | East, Midwest, West Territories, United States |
| Senior Counsel - Regulatory Law | Johnson & Johnson | New Brunswick, NJ |
| Senior Global Product Manager, Tissue Programs, New Product Development – Heart Valve Therapy-001476 | Edwards Lifesciences | Irvine, CA |
| Clinical Project Manager | Zimmer, Inc. | Warsaw, IN |
| Staff Engineer, Embolic Protection - Transcatheter Heart Valve | Edward Life Sciences | Irvine, CA |
| Staff Engineer, Embolic Protection - Transcatheter Heart Valve 001497 | Edwards Lifesciences | Irvine, CA |
| Documentation Coordinator - Heart Valve Therapy - 001453 | Edwards Lifesciences | Irvine, CA |
| Director, Quality - Diabetes Care, Job#00392422 | Roche Diagnostics | Indianapolis, IN |
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