| March 19, 2013 | News for medical technology professionals |
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- FDA OKs 2 HUD designations for artificial heart from SynCardia
The FDA has granted SynCardia Systems humanitarian use device exemption approval for its 50cc Total Artificial Heart to be used as a bridge-to-transplant for pediatric patients and others with small stature. The device also received HUD approval as a destination therapy system for heart failure patients at risk of imminent death. MassDevice.com (Boston)
(3/18)      
| Devices are Healthcare's Hottest Commodity in '13 |
| If Charles Dickens were alive today and wrote for Medical Device Daily he might be inclined to use his familiar opening line of "A Tale of Two Cities" to describe the current state of the med-tech industry: It was the best of times, it was the worst of times. Find out the details. |
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| Emerging Technologies | | |
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- 3D ear scanner from Lantos scores FDA clearance
The FDA has cleared Lantos Technologies to market its 3D ear scanning device. The scanner, set to be released later this year, allows for the development of hearing aid devices that are customized to each patient by streamlining the way ear topology is measured, according to the company. Boston Herald
(3/18)
- Salivary duct access devices from Cook Medical are available
A set of salivary duct access tools has been released by Cook Medical through its new Otolaryngology—Head and Neck Surgery business unit. The products, which are used to remove occlusions in the salivary duct, include the Kolenda salivary access introducer set, the NGage and NCircle salivary stone extractors, a serial dilator set and a guide wire. MedGadget.com
(3/18)
| Government & Regulatory | | |
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- Proposed budget hike would increase FDA oversight in China
A Senate bill that aims to raise the FDA's fiscal 2013 budget to $2.5 billion has gained support from the Alliance for a Stronger FDA, which calls it "strongly favorable" to the agency. The measure, which includes the new user fees for medical devices, drugs and biologics, provides $10 million to allow the agency to beef up its inspections in China, the group said. In-PharmaTechnologist.com
(3/18)
- 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.
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| Position Title | Company Name | Location |
| Sales / Technical Specialist | Kaneka Pharma America LLC | New York, NY |
| Sales Area Manager/Sales Rep of Neurovascular Intervention Products | Asahi Intecc USA, Inc. | Any location in US, CA |
| Sr.Regulatory Affaris Associate | Mindray DS USA, Inc. | Mahwah, NJ |
| Project Manager, Regulatory Affairs - Transfusion Medicine | Johnson & Johnson | Raritan, NJ |
| Associate Counsel | ACell, Inc. | Columbia, MD |
| Compliance Consultant 2 | DJO Global | Vista, CA |
| Accreditation Manager | American Association of Tissue Banks | McLean, VA |
| REGULATORY AFFAIRS SPECIALIST | Masimo Corporation | Irvine, CA |
| Director, Health Care Compliance | RTI Biologics | Alachua, FL |
| Manager, HCL Regulatory & Quality Compliance | Owens & Minor | Louisville, KY |
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