| May 10, 2013 | News for medical technology professionals |
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- NP Medical wins FDA nod for infusion therapy device
The FDA has cleared NP Medical to market its nPulse Valve Platform, a needle-free connector used during infusion therapy. The device has a dual seal to prevent the introduction of bacteria and provide leak protection in high-pressure and arterial applications. MedGadget.com
(5/8)      
 | 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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- Rainbow Medical reportedly lands $10M investment from Sony
Sony reportedly has pumped $10 million into Rainbow Medical, an Israeli firm that invests in medical-device manufacturers. Rainbow Medical, which specializes in devices that involve electrical stimulation of the body, has also received backing from Abbott Laboratories and Medtronic in the past. Sony's CEO has said the company wants to expand its medical operations, and the investment will allow Sony to ask for customized products. Globes (Israel)
(5/9)
| International Developments | | |
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- St. Jude's next-gen heart defibrillators gain CE mark
St. Jude Medical has earned the CE mark in Europe to market its Ellipse and SJM Assura implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. The devices automatically adjust voltage in the event of an electrical short and help reduce risk for lead abrasion. RTT News
(5/8)
| Science & Health | | |
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| Emerging Technologies | | |
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- New lightweight exoskeletons get closer to market
Among a new generation of lightweight powered exoskeletons is the 27-pound Indego, which can be fitted together from pieces carried in a backpack. The device, which allows paraplegics with spinal injuries or diseases such as cerebral palsy to walk independently, was developed by Vanderbilt University and demonstrated recently at the American Spinal Injury Association meeting in Chicago. National Public Radio/The Associated Press
(5/9)
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| Government & Regulatory | | |
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- FDA OKs Combat Medical's device to stem heavy bleeding
Combat Medical Systems has been cleared by the FDA to market its Combat Ready Clamp for use in treating junctional hemorrhage on the battlefield or any other emergency situation. The viselike device, which can be applied in less than 60 seconds, proves useful when manual pressure isn't enough and standard tourniquets don't work. MedGadget.com
(5/9)
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| Position Title | Company Name | Location |
| Regulatory Affairs Specialist | Sorin Group Canada | Burnaby, Canada |
| Assistant General Counsel, Regulatory | Kimberly-Clark | Roswell, GA |
| Compliance Consultant 2 | DJO Global | Vista, CA |
| Senior Software QA Engineer | IRIS International, Inc. | Chatsworth, CA |
| Principal Systems Engineer | IRIS International, Inc | Chatsworth, CA |
| Director, Regulatory Affairs - Critical Care - 002477 | Edwards Lifesciences | Irvine, CA |
| Director of Medical Management for Delaware Physicians Care | Aetna | Newark, DE |
| Manager, Compliance | Smith & Nephew | Memphis, TN |
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