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2014 User Fees

October 16, 2013 12:00 am | by U.S. Food & Drug Administration | Comments

Information regarding MDUFA III fees. Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR or BLA.                                

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World's First All Tissue Ablative Laser Scanning Handpiece for Dentistry

October 15, 2013 8:00 pm | by PR Newswire | Comments

Lasers4Dentistry, a division of Technology4Medicine, will launch the revolutionary X-Runner™ digital laser scanning handpiece at the upcoming meeting of the American Dental Association being held in New Orleans, LA from 31 October through...

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Diabetes Patients Have Better Options When It Comes to Heart Surgery

October 15, 2013 5:08 pm | by PR Newswire | Comments

For patients with diabetes and coronary artery disease in more than one artery, treatment with coronary artery bypass graft (CABG) surgery provided slightly better health status and quality of life between six months and two years than procedures...

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US Research Team Wins $1 Million Prize in Israel

October 15, 2013 4:18 pm | by The Associated Press | Comments

An Israeli nonprofit group has awarded a $1 million prize to a U.S.-based research team that is developing technology that allows paralyzed people to move things with their thoughts. Israel Brain Technologies presented the award on Tuesday...

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Researchers Developing an Artificial Leg with a Natural Gait

October 15, 2013 3:24 pm | by Marcia Goodrich, Michigan Tech | Comments

Walking is tricky business, as any toddler knows. And while most artificial feet and limbs do a pretty good job restoring mobility to people who have lost a leg, they have a ways to go before they equal the intricacy of a natural gait...  

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New 3D Method Used To Grow Miniature Pancreas

October 15, 2013 3:19 pm | by University of Copenhagen | Comments

An international team of researchers from the University of Copenhagen have successfully developed an innovative 3D method to grow miniature pancreas from progenitor cells. The future goal is to use this model to help in the fight against diabetes...

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Covidien's got a 'new approach' to peripheral arterial disease

October 15, 2013 2:26 pm | by Mass Device | Comments

Massachusetts medical device giant Covidien released results from a pair of studies, supporting use of the company's EverFlex self-expanding stent and combining directional atherectomy with drug-coated balloons in treatment of patient with...

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Amedica Launches Valeo II Anterior Lumbar Interbody Spinal Fusion Device

October 15, 2013 2:22 pm | by Amedica Corporation | Comments

Amedica Corporation, a biomaterial company, today announced the launch of its new Silicon Nitride Anterior Lumbar (AL) Interbody Fusion Device. The Valeo II AL Interbody Fusion Device includes enhancements that contribute to improved surgeon...

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Pulsar Vascular Receives CE Mark Approval for PulseRider

October 15, 2013 2:14 pm | by PR Newswire | Comments

Pulsar Vascular, a leading innovator in neurovascular technology, today announced it received European CE Mark approval for its lead product, the PulseRider®. This unique implant is used to bridge the neck of cerebral aneurysms previously not...

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Johnson & Johnson settles another DePuy ASR lawsuit

October 15, 2013 1:17 pm | by Mass Device | Comments

Johnson & Johnson settled another of the thousands of lawsuits it's facing over its recalled DePuy ASR metal-on-metal hip implant, according to court records. The lawsuit, MacDonald et al v. DePuy Orthopaedics Inc. et al, filed in the...

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Legal: Ivera takes another swing at rival catheter cap maker

October 15, 2013 1:00 pm | by Mass Device | Comments

Ivera Medical is taking a new tactic in targeting rival Catheter Connections, accusing the company of falsely advertising its catheter protection caps as U.S.-made. Ivera is asking for a jury trial to determine whether Cather Connections' label...

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Portly Taft Helped Usher in Modern Obesity Care

October 15, 2013 11:44 am | by Lauran Neergaard, AP Medical Writer | Comments

Way before Weight Watchers or "The Biggest Loser," a president known for his girth was helping to usher in a modern approach to treating obesity. Got a nagging doctor? The 27th president, William H. Taft did, way back in the early 1900s...

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Rapid Reversal of Diabetes after Gastric Banding Surgery

October 15, 2013 11:34 am | by Garvan Institute | Comments

Clinical researchers from Sydney’s Garvan Institute of Medical Research and St. Vincent’s Hospital have shown that a form of weight loss surgery, known as ‘gastric banding’, brings about reversal of diabetes in some patients, and dramatic...

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New Imaging Technique Can Identify Breast Cancer Subtypes and Early Treatment Response

October 15, 2013 11:28 am | by American Association for Cancer Research | Comments

An optical imaging technique that measures metabolic activity in cancer cells can accurately differentiate breast cancer subtypes, and it can detect responses to treatment as early as two days after therapy administration, according to a study...

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From Football to Flies: Lessons about Traumatic Brain Injury

October 15, 2013 11:26 am | by University of Wisconsin-Madison | Comments

Faced with news of suicides and brain damage in former professional football players, geneticist Barry Ganetzky bemoaned the lack of model systems for studying the insidious and often delayed consequences linked to head injuries...   

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