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FDA approves 'Cornell Dots' for first clinical trial in humans to diagnose cancer

"Cornell Dots" - brightly glowing nanoparticles - may soon be used to light up cancer cells to aid in diagnosing and treating cancer. The U.S. Food and Drug Administration has approved the first clinical trial in humans of the new technology.

1 Feb 2011

MRI screening for breast cancer delivers fewer false-positive results over time

MRI screening for breast cancer delivers consistent rates of cancer detection and fewer false-positive results over time, according to a new study published online and in the April print edition of Radiology.

1 Feb 2011

Avantra Biosciences selects TGen Drug Development for new biomarker quantitation platform

Avantra Biosciences today announced the selection of TGen Drug Development as a key test site for Avantra's new biomarker quantitation platform.

1 Feb 2011

McLeod Health joins SafetyConnect to effectively monitor clinical data and reduce infections

By eliminating piles of paper, McLeod Health is now able to more effectively monitor clinical data and reduce infections with the help of the Premier healthcare alliance's SafetyConnect™ program.

1 Feb 2011

Widespread screening or ultrasound for blocked neck arteries not necessary to determine stroke risk

Widespread screening or routine ultrasound for blocked neck arteries to determine stroke risk isn't necessary, according to new guidelines from the American Heart Association/American Stroke Association, American College of Cardiology and other groups.

1 Feb 2011

Sprint Fidelis ICD leads fail more often in younger patients with hereditary heart disease

The recalled Sprint Fidelis implantable cardioverter-defibrillator leads failed more often in younger patients, women, and individuals with hereditary heart disease, according to a multicenter study published online Jan. 17 in Circulation. The researchers found that lead failure was not associated with death or serious injuries.

1 Feb 2011

FDA schedules panel meeting date for BioMimetic Therapeutics's Augment Bone Graft PMA

BioMimetic Therapeutics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled an Orthopedic and Rehabilitation Devices Panel meeting on May 12, 2011 to review the Company's Premarket Approval (PMA) application for Augment™ Bone Graft for the treatment of foot and ankle fusions in the U.S.

1 Feb 2011

Favorable clinical results from Endologix's Nellix technology against EVAR

Endologix, developer of minimally invasive treatments for aortic disorders, announced today the publication of favorable clinical results for the Nellix technology for the endovascular repair of abdominal aortic aneurysm.

1 Feb 2011

DNA Direct implements four new health plan clients for molecular diagnostic and genetic tests

DNA Direct, a wholly owned subsidiary of Medco Health Solutions, Inc. and a provider of guidance and decision support for genomic medicine, today announced four new health plan clients that are implementing DNA Direct's Policy & Benefit Support Program for molecular diagnostic and genetic tests.

1 Feb 2011

HighRes Biosolutions to build High-Throughput Laboratory Network for LANL-UCLA

A compact, self-contained, automated system for surveillance and screening of potential pandemic strains of influenza and other deadly infectious diseases is a step closer to reality, thanks to an agreement between Los Alamos National Laboratory, the University of California Los Angeles School of Public Health, and HighRes Biosolutions of Boston, Massachussets.

1 Feb 2011

Simple hTERT analysis may provide useful prognostic tool in advanced non-small cell lung cancer

High levels of circulating DNA may indicate faster progression of lung cancer and lower overall survival, according to a study published in the February edition of the Journal of Thoracic Oncology, the official publication of the International Association for the Study of Lung Cancer (IASLC).

1 Feb 2011

Brain scans can predict smokers' behavior change: New study

Brain scans showing neural reactions to pro-health messages can predict if you'll keep that resolution to quit smoking more accurately than you yourself can. That's according to a new study forthcoming in Health Psychology, a peer-reviewed journal.

1 Feb 2011

Health Canada approves Microsulis Medical's Accu2i percutaneous microwave tissue ablation system

Microsulis Medical Limited, the leading company in microwave technology for medical devices, today announced that it has received approval from Health Canada for the Acculis Accu2i percutaneous microwave tissue ablation system for the coagulation of soft tissue during surgical procedures.

1 Feb 2011

ACC introduces new chromogenic endotoxin detection system

Associates of Cape Cod, Inc., (ACC) is proud to introduce its NEW CHROMOGENIC ENDOTOXIN DETECTION SYSTEM incorporating the enhanced Pyrochrome® chromogenic reagent and the new-to-market Pyros Kinetix® Flex Incubating Kinetic tube reader. This system offers our customers diverse options for conducting endotoxin testing.

1 Feb 2011

Covidien announces limited release of Endo GIA curved tip and black reloads with Tri-Staple technology

Covidien, a leading global provider of healthcare products, today announced that its new Endo GIA curved tip and black reloads with Tri-Staple technology are available in limited release with a full U.S. roll out expected by mid-year.

1 Feb 2011

Abbott receives US regulatory clearance and Japanese approval for TREK Coronary Dilatation Catheters

Abbott today announced it has received regulatory clearance in the United States and approval in Japan for its TREK and MINI-TREK Coronary Dilatation Catheters for the treatment of coronary artery disease. The TREK system is used in angioplasty procedures and is designed to enable interventional cardiologists to open patients' narrowed coronary arteries. The TREK system received CE Mark and was launched in Europe in May 2010.

1 Feb 2011

FDA approves Boston Scientific's Renegade HI-FLO Fathom Pre-Loaded System

Boston Scientific Corporation today announced that the U.S. Food and Drug Administration has approved its Renegade HI-FLO Fathom Pre-Loaded System for selective access and delivery of diagnostic, embolic and therapeutic materials into the peripheral vasculature.

1 Feb 2011

MRI T2 can determine iron overload in beta-thalassemic patients

Iron overload is a common and serious problem in thalassemic major patients. As iron accumulation is toxic in the body's tissues, accurate estimation of iron stores is of great importance in these patients to prevent iron overload by an appropriate iron chelating therapy.

1 Feb 2011

FDA grants Mederi 510(k) clearance for new MDRF1 radiofrequency generator

Mederi Therapeutics Inc. announced today that it has received FDA 510(k) clearance for its new MDRF1 Generator.

1 Feb 2011

Cappella initiates multi-center Italian Sideguard open label clinical study

Cappella Medical Devices announces initiation of the multi-center Italian Sideguard® open label clinical study. The Principal Investigator (PI) of the study, Dr. Giuseppe Massimo Sangiorgi at the Policlinico di Modena - University of Modena and Reggio Emilia, in Modena, Italy stated, "The side branch ostium anatomy requires a unique technology solution to effectively manage and optimize treatment.

1 Feb 2011

Device / Technology News

FDA approves 'Cornell Dots' for first clinical trial in humans to diagnose cancer

MRI screening for breast cancer delivers fewer false-positive results over time

Avantra Biosciences selects TGen Drug Development for new biomarker quantitation platform

McLeod Health joins SafetyConnect to effectively monitor clinical data and reduce infections

Widespread screening or ultrasound for blocked neck arteries not necessary to determine stroke risk

Sprint Fidelis ICD leads fail more often in younger patients with hereditary heart disease

FDA schedules panel meeting date for BioMimetic Therapeutics's Augment Bone Graft PMA

Favorable clinical results from Endologix's Nellix technology against EVAR

DNA Direct implements four new health plan clients for molecular diagnostic and genetic tests

HighRes Biosolutions to build High-Throughput Laboratory Network for LANL-UCLA

Simple hTERT analysis may provide useful prognostic tool in advanced non-small cell lung cancer

Brain scans can predict smokers' behavior change: New study

Health Canada approves Microsulis Medical's Accu2i percutaneous microwave tissue ablation system

ACC introduces new chromogenic endotoxin detection system

Covidien announces limited release of Endo GIA curved tip and black reloads with Tri-Staple technology

Abbott receives US regulatory clearance and Japanese approval for TREK Coronary Dilatation Catheters

FDA approves Boston Scientific's Renegade HI-FLO Fathom Pre-Loaded System

MRI T2 can determine iron overload in beta-thalassemic patients

FDA grants Mederi 510(k) clearance for new MDRF1 radiofrequency generator

Cappella initiates multi-center Italian Sideguard open label clinical study

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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