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Update: Clinical Trial Establishes Catheter-based Aortic Valve Replacement As New Standard of Care for Patients Who Cannot Undergo Surgery

September 23, 2010 9:35 am | by Bio-Medicine.Org | News | Comments

WASHINGTON, Sept. 23 /- One-year data from the PARTNER clinical trial, published yesterday in the New England Journal of Medicine, demonstrate that transcatheter aortic-valve implantation, compared with standard therapy, resulted in significantly lower rates of death among patients who...


Promising New Therapy for Drug-Resistant Hypertension Presented at Interventional Cardiology Meeting in Washington, D.C.

September 23, 2010 9:35 am | by Bio-Medicine.Org | News | Comments

SAN LEANDRO, Calif., Sept. 23 /- Preclinical data of a novel therapy designed to treat drug-resistant hypertension (high blood pressure) was presented Tuesday, September 21st, at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 Conference in Washington, DC, by Christopher D....


Lilly CEO Says Regional Innovation Clusters Can Renew the Nation's Economy

September 23, 2010 9:34 am | by Bio-Medicine.Org | News | Comments

WASHINGTON, Sept. 23 /- In the keynote address to a conference on Regional Innovation Clusters today, John C. Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company (NYSE: LLY ), argued for federal policies that further encourage regional economic innovation as a key to...


Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

September 23, 2010 9:30 am | by U.S. Food & Drug Administration | News | Comments

Restrictions in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.


Post-acute care sector poses funding challenges

September 23, 2010 7:45 am | by The Associated Press | News | Comments

The post-acute care sector of the health care services industry has seen a spike in patient volume, but challenging Medicare funding cuts still loom, according to an FBR Capital Markets analyst.FBR initiated coverage for three home health and hospice operators — Amedisys Inc., Gentiva Health...

Systagenix, ECI Biotech enter wound care deal

September 23, 2010 7:32 am | by Mass High Tech: The Journal of New England Technology | News | Comments

ECI Biotech Inc. has entered into an agreement with Systagenix Wound Management Inc., a subsidiary of Johnson & Johnson, designed to spur the development of diagnostic sensors to help diagnose and treat chronic wounds.


Drilled Core Tubes Integral for Liquid Filtration Systems

September 23, 2010 6:52 am | Product Releases | Comments

Marshall Manufacturing Company utilizes automated manufacturing cells that were designed by Marshall’s in-house engineering team. Each manufacturing cell is capable of machining its own specific range of tube diameters and lengths.

Coin Cell Batteries Feature Extended Battery Life Breakthroughs

September 23, 2010 6:45 am | Product Releases | Comments

Contour Energy Systems Inc., an innovative portable power company commercializing next-generation battery systems, is releasing its first line of coin cell batteries with availability starting in the fourth quarter 2010.


Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori

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

This document recommends studies for establishing the performance characteristics of diagnostic devices for the direct or indirect detection of H. pylori bacteria in human blood, serum, urine, stool or breath specimens.

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).


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.

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...


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.


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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