| March 15, 2013 | News for medical technology professionals |
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- VertiFlex sells noncore spinal technology to Stryker
Certain noncore spinal technology from VertiFlex will be acquired by Stryker for undisclosed terms. Proceeds from the sale will go toward the development of VertiFlex's platform for spinal stenosis therapies, the Clemente, Calif.-based company said in a release. BeckersASC.com
(3/14)      
 | Streamline Combination Product Development
This complimentary white paper from Novella Clinical explores combination product regulatory strategies - from classification to market clearance. Combination product sponsors can avoid numerous regulatory hurdles by downloading this white paper now: Clarifying the Regulatory Road for Combination Products. |
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| Business & Market Trends |  |  |
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- Calif. diabetes monitoring device firm hopes to raise $1.7M
Epinex Diagnostics is seeking to obtain as much as $1.7 million in a private placement after receiving $318,000 from investors. The Tustin, Calif.-based company is working on a glycated albumin-based test that can be used to monitor glycemic control in type 2 diabetes patients over an intermediate period. MedCityNews.com
(3/14)
| International Developments | | |
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| Science & Health | | |
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| Emerging Technologies | | |
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- Siemens introduces fully digital 2-in-1 imaging device
The Luminos Fusion system, which combines full digital radiography and fluoroscopy into a single unit, has been launched by Siemens. The technology, which comes with flat panel detectors and other features, is designed to provide a more affordable alternative to existing devices, and the two-in-one system can be used at greater capacity and prevent idle time. MedGadget.com
(3/12)
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| The Buzz(CORPORATE ANNOUNCEMENTS)
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| Government & Regulatory | | |
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CEO of Merit Medical weighs in on first-to-file patent scheme: The first-to-file patent program scheduled to take effect this week represents another obstacle for medtech firms to obtain regulatory clearance in the U.S., Merit Medical CEO Fred Lampropoulos said. "It’s one of the reasons why Europe is becoming more attractive to us, because we think that it’s a more favorable environment for business," he said. Medical Device & Diagnostic Industry/DeviceTalk
(3/14)
- Medical Device Complaints, MDRs and Reports
Tuesday, May 7 – Wednesday, May 8
Sheraton Crystal City, Arlington, Va.
FDA personnel and expert industry faculty discuss the elements of an effective complaint management system, the FDA's expectation about trending complaints from non-U.S. markets, how to ensure that your electronic records database handling complaints complies with 21 CFR Part 11, how to investigate complaints to determine if they are MDRs, the do's and don'ts when informing the FDA of a product problem, and the FDA's involvement in health hazard evaluation and classification. Visit MTLI online for more information.
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| Position Title | Company Name | Location |
| Sales Area Manager/Sales Rep of Neurovascular Intervention Products | Asahi Intecc USA, Inc. | Any location in US, CA |
| Project Manager, Regulatory Affairs - Transfusion Medicine | Johnson & Johnson | Raritan, NJ |
| Associate Counsel | ACell, Inc. | Columbia, MD |
| Compliance Consultant 2 | DJO Global | Vista, CA |
| Director, Health Care Compliance | RTI Biologics | Alachua, FL |
| Accreditation Manager | American Association of Tissue Banks | McLean, VA |
| REGULATORY AFFAIRS SPECIALIST | Masimo Corporation | Irvine, CA |
| Manager, HCL Regulatory & Quality Compliance | Owens & Minor | Louisville, KY |
| Biostatistician - Post Market Surveillance | Johnson & Johnson | Raynham, MA |
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| Click here to view more job listings. |
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