| February 6, 2013 | News for medical technology professionals |
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 | The odds of receiving an Inspectional Observation (483) or a subsequent Warning Letter have been sharply on the rise, and the seriousness of each remains high. How do you respond? |
| Business & Market Trends |  |  |
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- GluMetrics obtains about $3 million in financing round
A regulatory filing disclosed that GluMetrics has obtained more than $3 million in a funding round aiming for $6 million. The California-based company is the maker of the GluCath system, a single-use intravascular device that combines a sensor and catheter to monitor glucose levels in ICU patients continuously. MedCityNews.com
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| 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. |
- Withdrawal of EU medtech symbols standard leaves regulatory gap
The removal of the harmonized symbols medtech standard in Europe, known as EN 980, has created a gap in the European regulatory standards framework. EN 980 was expected to be replaced by the global standard ISO 15223-1 of 2012; however, that standard hasn't been harmonized for application in Europe. An official said the regulatory vacuum "was unintentional and will be put right at the next harmonized standard listing publication." Clinica (subscription required)
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| Science & Health | | |
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| Emerging Technologies | | |
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- CareFusion's laparoscopic retractor debuts in North America
The Snowden-Pencer retractor system, which is used in laparoscopic procedures, is being launched by CareFusion in North America. The device, which forms into a pretzel shape when the knob on the handle is turned, comes with a five-millimeter smooth shaft, an atraumatic flexible tip and a flush port for sterilization and cleaning. MedGadget.com
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| Government & Regulatory | | |
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- AdvaMed shares concerns about CED with CMS
AdvaMed has filed comments with the CMS about the draft guidance on Coverage with Evidence Development, a program that would let evidence be collected on new medical devices after reimbursement. Among AdvaMed's concerns are the possibility that CED effectively could become another requirement in achieving Medicare reimbursement coverage or that it would be considered standard when clinical trials do not mirror the demographics of Medicare recipients. "A coverage process that delays patient access to new technologies through excessive requirements ... ultimately harms beneficiaries," said Chandra Branham, AdvaMed vice president of payment and health care delivery policy. Clinica
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- House majority leader and Rep. Paulsen reiterate stance against medical device tax
Congress should take swift action on the 2.3% medical device tax, said Rep. Erik Paulsen, R-Minn., who sees opportunities for repeal amid corporate tax reform talks. "This is about keeping good, domestic manufacturing jobs here in the U.S., not shipping them overseas, and that's a part of the larger tax conversation that needs to happen," he said. House Majority Leader Eric Cantor, R-Va., also emphasized his stance against the device tax
while speaking at the American Enterprise Institute. MassDevice.com (Boston)
(2/5), MassDevice.com (Boston)
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- Medical Device Reimbursement Workshop
Tuesday, Feb. 26 – Wednesday, Feb. 27
Sheraton Crystal City, Arlington, Va.
Learn from medical device reimbursement experts what new legislative and regulatory changes apply to the area of reimbursement; the key reimbursement issues for medical technology; how Medicare coverage is determined at the national and local levels; the role of MEDCAC; why technology assessments are important; how clinical trial results impact payers; what you need to do to keep up on new reimbursement developments relevant to your products; how to maintain a nimble, dynamic, effective, ongoing reimbursement program; what to do when reimbursement is denied; drill-down coding systems; differences in inpatient and outpatient payment systems; physician fee schedules and product design; how to negotiate CMS coverage; how to plan for the new health care reform landscape deal with comparative effectiveness; and how to manage international reimbursement. Visit MTLI online for more information.
- Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 28 – Friday, March 1
Sheraton Crystal City, Arlington, Va.
Senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead professionals through the strategic considerations and practical steps of filing a premarket approval, illustrated with real-world case studies. Topics include: the new acceptance and filing review guidance document; the eCopy Program for Medical Device Submissions; strategy development and evidence requirements; productive meetings with the FDA; the mechanics of premarket approval submission development; advisory panels; inspectional activity; and conditions of approval studies. Visit MTLI online for more information.
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| Position Title | Company Name | Location |
| Neurovascular Intervention Marketing Manager | Asahi Intecc | Santa Ana, CA |
| Engineer, Process Development | ArthroCare Corporation | Irvine, CA |
| Legal Counsel II | Medtronic, Inc. | Minneapolis, MN or Washington, DC, United States |
| Regional Service Manager | Philips | Hartford, CT |
| Sr. QA Manager - Quality Systems (Santa Barbara) | Allergan | Santa Barbara, CA |
| Product Support Specialist IV | ArthroCare Corporation | Austin, TX |
| Director of Clinical Affairs | Endologix | Irvine, CA |
| Sr. Clinical Research Associate | Endologix, Inc. | Irvine, CA |
| Area Reimbursement Manager (Central U.S. or Northeast U.S.) | SI-BONE, Inc | Multiple Locations, United States |
| Program Director, Regulatory Affairs | Johnson & Johnson | Fremont, CA |
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| Click here to view more job listings. |
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 | I've learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel."
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American author and poet
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