Restrictions in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
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...
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.
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.
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Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pyloriSeptember 23,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 MeetingSeptember 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Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detec...September 23,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This draft guidance document provides industry and agency staff with updated recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs)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).
Possibility of the presence of a small common beetle in the product, which could result in symptoms of gastrointestinal discomfort.
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...
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.
Results of TAXUS ATLAS clinical program presented at TCT
Company presents one-year clinical data at TCT on its platinum chromium paclitaxel-eluting coronary stent from PERSEUS trial
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,...
Effective Self-Management of Blood Glucose Can be Achieved by Using Meters With Advanced Features Paired With Diabetes EducationSeptember 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...