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FDA clears BD MAX assay for detecting GBS DNA in Lim Broth cultures

BD announced today the U.S. Food and Drug Administration clearance of the BD MAX Group B Streptococcus (GBS) Assay and Clinical Laboratory Improvement Amendments (CLIA) moderate complexity test categorization on the second-generation BD MAX System.

From BD (Becton, Dickinson and Company) 29 Mar 2012

Many medical implants never tested for safety

A new investigation by Consumer Reports reveals that while tens of millions of American consumers live with medical devices implanted in their bodies, many of these implants have never been tested for safety and manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing their products to market.

29 Mar 2012

MabCure retains CUNY CAT to evaluate monoclonal antibodies against ovarian cancer

MabCure Inc., a leading developer of antibody-based technology for the diagnosis and treatment of ovarian, prostate, colorectal and other cancers, has retained the CUNY Center for Advanced Technology (CUNY CAT) to evaluate its monoclonal antibodies against ovarian cancer cells as diagnostic reagents.

29 Mar 2012

Greenway announces availability of PrimeMOBILE

Greenway Medical Technologies, Inc. today announced the availability of its remote clinical and financial solution PrimeMOBILE as a native application for download onto Android smartphone and tablet devices.

29 Mar 2012

IMRT associated with reduced toxicities when compared with standard whole breast irradiation

Breast cancer patients treated with intensity modulated radiation therapy (IMRT) instead of standard whole breast irradiation (WBI) have a lower incidence of acute or chronic toxicities, according to a study in Practical Radiation Oncology (PRO), the official clinical practice journal of the American Society for Radiation Oncology (ASTRO).

29 Mar 2012

Smiths Medical initiates voluntary market withdrawal of CoZmonitor Blood Glucose Monitoring Systems

Smiths Medical, a leading global medical device manufacturer, announced today that it is initiating a U.S. and Canada, voluntary market withdrawal of CoZmonitor Blood Glucose Monitoring Systems. The FDA has been apprised of this action.

29 Mar 2012

EU's Safety Evaluation Ultimately Replacing Animal Testing initiative tests Roche's xCELLigence system

Roche's xCELLigence RTCA System is being used in the European Union's SEURAT (Safety Evaluation Ultimately Replacing Animal Testing) initiative to run five years from 2011 to 2016.

From Roche Sequencing and Life Science 29 Mar 2012

MESO-1 device can help in diagnosis and treatment of cancer

A new device designed to more effectively produce DNA samples for genetic testing from slide-mounted tissue samples is better equipped than most models on the market to help in the diagnosis and treatment of cancer.

29 Mar 2012

Interleukin, U-M School of Dentistry complete enrollment in PST Genetic Test study

The University of Michigan School of Dentistry and Interleukin Genetics, Inc. announced today the completion of patient enrollment for a landmark clinical study using Interleukin's PST Genetic Test to determine if dental patients can be risk-stratified to guide frequency of preventive dental visits and reduce the adverse outcomes of periodontal disease progression, such as tooth loss.

29 Mar 2012

Scientists uncover new layer of information in the genetic code

A hidden and never before recognized layer of information in the genetic code has been uncovered by a team of scientists at the University of California, San Francisco (UCSF) thanks to a technique developed at UCSF called ribosome profiling, which enables the measurement of gene activity inside living cells - including the speed with which proteins are made.

29 Mar 2012

Luna to extend development and supply agreement with Intuitive Surgical

Luna Innovations Incorporated announced today that it will be extending its development work through 2012 under its development and supply agreement with Intuitive Surgical, Inc., as they work towards the integration of Luna's shape and position sensing technology into Intuitive's medical robotic products.

29 Mar 2012

iSonea launches post-market study of WheezoMeter device for pediatric asthma

Medical technology company, iSonea Ltd. today announced the launch of a post-market study using iSonea's WheezoMeter monitoring technology.

29 Mar 2012

ASGE announces honorees of new endoscopy unit recognition program

The American Society for Gastrointestinal Endoscopy (ASGE) has recognized 18 endoscopy units as part of its program specifically dedicated to promoting quality in endoscopy, in all settings where it is practiced in the United States.

29 Mar 2012

Henry Schein launches Dentrix G5 practice management system

Henry Schein Inc., the largest provider of health care products and services to dental, medical and animal health office-based practitioners, today announced the launch of Dentrix G5, a new version of the Dentrix practice management system.

29 Mar 2012

LivHOME introduces LivIndependa for older adults

LivHOME, Inc., one of the nation's largest providers of professionally led at-home care for seniors, today announced the launch of LivIndependa, a tablet-computer based remote care service for older adults.

29 Mar 2012

Inhibitory control test and lactulose for MHE saves more than $3 million over 5 years

A late stage liver condition, known as minimal hepatic encephalopathy (MHE), is associated with impaired driving skills and greater risk of motor vehicle accidents. Cost analysis of management strategies for detection and treatment of MHE are published in the April issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.

29 Mar 2012

Enrollment complete in Aperion Biologics' Z-Lig Anterior Cruciate Ligament Reconstruction Device trial

Aperion Biologics, Inc. announced that it has completed patient enrollment and implantation in the Company's clinical trial of its Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) Device for the treatment of ligament injuries of the knee.

29 Mar 2012

EU-funded project to help control appetite, combat obesity

The University of Liverpool is leading a £6milllion European project to develop and test new food products with satiating qualities to help control appetite, manage weight and combat obesity.

29 Mar 2012

FDA approves Avioq HTLV-I/II Microelisa System

Avioq, Inc. announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Avioq HTLV-I/II Microelisa System. The test is used for the qualitative detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Human T-Lymphotropic Virus Type II (HTLV-II) in human serum or plasma.

29 Mar 2012

CryoConcepts introduces breakthrough low-cost and disposable cryosurgical device

CryoConcepts, LP is announcing the introduction of the first disposable, nitrous oxide-based cryosurgical device to physicians in the US and abroad. The pen-shaped device is called CryOmega® and tests have shown the unit is clinically effective and provides pinpoint accuracy at freezing temperatures of -89C.

28 Mar 2012

Device / Technology News

FDA clears BD MAX assay for detecting GBS DNA in Lim Broth cultures

Many medical implants never tested for safety

MabCure retains CUNY CAT to evaluate monoclonal antibodies against ovarian cancer

Greenway announces availability of PrimeMOBILE

IMRT associated with reduced toxicities when compared with standard whole breast irradiation

Smiths Medical initiates voluntary market withdrawal of CoZmonitor Blood Glucose Monitoring Systems

EU's Safety Evaluation Ultimately Replacing Animal Testing initiative tests Roche's xCELLigence system

MESO-1 device can help in diagnosis and treatment of cancer

Interleukin, U-M School of Dentistry complete enrollment in PST Genetic Test study

Scientists uncover new layer of information in the genetic code

Luna to extend development and supply agreement with Intuitive Surgical

iSonea launches post-market study of WheezoMeter device for pediatric asthma

ASGE announces honorees of new endoscopy unit recognition program

Henry Schein launches Dentrix G5 practice management system

LivHOME introduces LivIndependa for older adults

Inhibitory control test and lactulose for MHE saves more than $3 million over 5 years

Enrollment complete in Aperion Biologics' Z-Lig Anterior Cruciate Ligament Reconstruction Device trial

EU-funded project to help control appetite, combat obesity

FDA approves Avioq HTLV-I/II Microelisa System

CryoConcepts introduces breakthrough low-cost and disposable cryosurgical device

Exploring the nanoscale: How AFM is transforming cosmetic science

Innovating Texture and Culture in Plant-Based Foods

Advancing brain microphysiological systems (bMPS)

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