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Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

September 23, 2010 6:35 am | by U.S. Food & Drug Administration | News | Comments

On December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal...

Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detec...

September 23, 2010 6:34 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document provides industry and agency staff with updated recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Helicobacter pylori (H. pylori).

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Similac Powder Infant Formulas: Recall

September 23, 2010 6:34 am | by U.S. Food & Drug Administration | News | Comments

Possibility of the presence of a small common beetle in the product, which could result in symptoms of gastrointestinal discomfort.

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Federally funded massive RAM computer speeds genome assembly

September 23, 2010 6:34 am | by Baylor College of Medicine | News | Comments

A new massive RAM computing resource for genomic assembly with two nodes (or computers) that each have 1 terabyte of RAM (random access memory) will enable genomic scientists to assemble complicated genomes faster and with fewer errors, said scientists at the Baylor College of Medicine...

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Comment: Changing the FDA; a look through the cliché files

September 23, 2010 6:34 am | by Diagnostic Imaging | News | Comments

There’s been plenty of talk over the years about the FDA being broken—its review process is too slow, its decisions flawed, its costs too high. The talk has come from industry, the public, and academia. The catalyst has been frustration.

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Long-Term Data Show Advantages for TAXUS® Liberte® Stent in Small Vessels and Long Lesions

September 23, 2010 6:34 am | by Boston Scientific | News | Comments

Results of TAXUS ATLAS clinical program presented at TCT

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Boston Scientific's TAXUS® Element™ Stent Demonstrates Strong Outcomes in Diabetic Patients

September 23, 2010 6:34 am | by Boston Scientific | News | Comments

Company presents one-year clinical data at TCT on its platinum chromium paclitaxel-eluting coronary stent from PERSEUS trial

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BioMarin Appoints William Young and Kenneth Bate to Its Board of Directors

September 23, 2010 6:34 am | by Bio-Medicine.Org | News | Comments

NOVATO, Calif., Sept. 23 /- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN ) announced today the appointment of William D. Young and Kenneth M. Bate to its Board of Directors. "We are extremely pleased to welcome William Young and Kenneth Bate to our Board of Directors.  With experience,...

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Effective Self-Management of Blood Glucose Can be Achieved by Using Meters With Advanced Features Paired With Diabetes Education

September 23, 2010 6:33 am | by Bio-Medicine.Org | News | Comments

TARRYTOWN, N.Y., Sept. 23 /- According to a new study, people with diabetes, especially those treated with insulin, may achieve optimal blood sugar control when they understand the impact of food on blood sugar and they utilize useful advanced blood glucose meter (BGM) features such as...

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Abbott and Reata Pharmaceuticals Announce Agreement to Develop and Commercialize Bardoxolone Methyl for Chronic Kidney Disease Outside the U.S.

September 23, 2010 6:33 am | by Bio-Medicine.Org | News | Comments

Abbott and Reata Pharmaceuticals Announce Agreement to Develop and... -- ABBOTT PARK, Ill. and IRVING, Texas, Sept. 23 /-

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Asian Medical Markets Expert to Attend the MD & M Midwest Conference

September 23, 2010 6:32 am | by Bio-Medicine.Org | News | Comments

BETHESDA, Md., Sept. 23 /- Pacific Bridge Medical will be attending the Medical Design and Manufacturing (MD&M) Midwest Conference from September 28-30, 2010, at the Donald E. Stephens Convention Center in Rosemont, Illinois. MD&M Midwest is part of a national conference series...

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Corgenix Reports Fiscal 2010 Financial Results

September 23, 2010 6:32 am | by Bio-Medicine.Org | News | Comments

DENVER, Sept. 23 /- Corgenix Medical Corporation (OTC Bulletin Board: CONX ), a worldwide developer and marketer of diagnostic test kits, today filed its fiscal year Form 10-K and reported financial results. The report disclosed that the company's operating results have advanced for the...

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Mayo Clinic Research on SurgiCount To Be Presented at Conferences

September 23, 2010 6:32 am | by Bio-Medicine.Org | News | Comments

TEMECULA, Calif., Sept. 23 /- SurgiCount Medical, the wholly-owned operating subsidiary of Patient Safety Technologies, Inc. (OTC Bulletin Board: PSTX ), announced that results of independent, unsponsored clinical research conducted by the Mayo Clinic on their multi-year effort to reduce...

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Latin American Aortic Stent Graft Market to Reach Over $150 Million by 2015, According to Millennium Research Group

September 23, 2010 6:32 am | by Bio-Medicine.Org | News | Comments

TORONTO, Sept. 23 /- According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, Latin American physicians will increasingly adopt abdominal and thoracic endovascular aortic repair in place of surgical repair through 2015 as awareness of...

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The New Face of Body Contouring

September 23, 2010 6:32 am | by Bio-Medicine.Org | News | Comments

LOUISVILLE, Colo., Sept. 23 /- As technologies for fat removal become more advanced, physicians now have a superior choice in not only reshaping the body but also recycling the fat to further enhance appearance. According to the most recent statistics from the American Society for...

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