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'Obamacare' Tax Not Meeting Revenue Target

August 20, 2014 | by Stephen Ohlemacher, Associated Press | Comments

An "Obamacare" tax on medical devices is falling short of its revenue target because thousands of companies aren't paying it, according to a government audit released Tuesday. The audit by the Treasury inspector general for tax administration...

FDA Approves Changes to Manufacturing Process for Covidien’s Pipeline Embolization Device

August 21, 2014 10:48 am | Comments

Covidien plc (NYSE: COV) today announced that the U.S. Food and Drug Administration (FDA) has approved changes to the manufacturing process for the polytetrafluoroethylene (PTFE) coating on the delivery wire of the company’s...

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Covidien Opens Advanced Medical Technology Center in Brazil

August 21, 2014 10:36 am | Comments

Covidien plc (NYSE: COV) today officially opened its Covidien Center of Innovation Brazil (CCI Brazil), further expanding its educational and research capabilities in a key emerging market. The CCI will help educate clinicians in...

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Ultrasound-Based Wound Healing System Receives FDA Clearance

August 21, 2014 10:12 am | by PR Newswire | Comments

Celleration, Inc., a privately held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies to treat wounds, has announced they received FDA clearance for their next generation UltraMIST...

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Most IVD Companies Looked Outside Europe and US For Growth

August 21, 2014 10:06 am | by Kalorama Information | Comments

Growth in the $54.6 billion in 2013 came from emerging markets while developed nation markets grew slowly, according to Kalorama Information. The healthcare market research publisher said that China Brazil, and Korea were among...

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FDA 510(k) Clearance for Philips' TAVI Precision Treatment Planning Application

August 21, 2014 10:03 am | by PR Newswire | Comments

Royal Philips today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments. Through 3D imaging, the...

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First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device

August 21, 2014 10:01 am | by PR Newswire | Comments

AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. AliveCor's automated analysis...

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University Spinoff Aims to Hit the Mark Precisely with Brain-Scanning Tool

August 20, 2014 2:31 pm | by David Tenenbaum, University of Wisconsin-Madison | Comments

As brain surgeons test new procedures and drugs to treat conditions ranging from psychiatric disorders to brain cancer, accuracy is becoming an ever-greater issue. In treating the brain, the state of the art today starts with images from a...

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Web-Based App Predicts Glioma Mutations

August 20, 2014 2:09 pm | by University of Kentucky | Comments

A new web-based program developed by University of Kentucky Markey Cancer Center researchers will provide a simple, free way for healthcare providers to determine which brain tumor cases require testing for a genetic mutation. Gliomas – a type...

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Test Reliably Detects Inherited Immune Deficiency in Newborns

August 20, 2014 12:00 pm | by NIH/National Institute of Allergy and Infectious Diseases | Comments

A newborn screening test for severe combined immunodeficiency (SCID) reliably identifies infants with this life-threatening inherited condition, leading to prompt treatment and high survival rates, according to a study supported by the National...

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Coronary Arteries Hold Heart-Regenerating Cells

August 20, 2014 11:47 am | by Vanderbilt University Medical Center | Comments

Endothelial cells residing in the coronary arteries can function as cardiac stem cells to produce new heart muscle tissue, Vanderbilt University investigators have discovered. The findings, published recently in Cell Reports, offer insights...

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Novel Gene Predicts Both Breast Cancer Relapse and Response to Chemotherapy

August 20, 2014 10:37 am | by ACN Newswire | Comments

Scientists have made it easier to predict both breast cancer relapses and responses to chemotherapy, through the identification of a unique gene. The newly found marker could help doctors classify each breast cancer patient and customize a...

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CardiacAssist Receives Health Canada Approval for PROTEK Duo Veno-Venous Cannula

August 20, 2014 10:28 am | by The Associated Press | Comments

CardiacAssist, Inc. has announced that it has received a Class 2 medical device license from Health Canada for its new PROTEK Duo veno-venous cannula. The PROTEK Duo is licensed for use as a single cannula for both venous drainage and reinfusion...

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Novel Human Tissue Samples Available for Research and Development

August 20, 2014 10:28 am | by The Associated Press | Comments

Human tissues are extensively employed by pharmaceutical and academic researchers to identify and validate new biomarkers and drug discovery targets. Such tissues are also widely used to study the efficacy, reproducibility, and safety of...

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510k Approval for SMART Meter and App for Improving Diabetes Health

August 20, 2014 10:06 am | by PR Newswire | Comments

Philosys announces it has received U.S. Food and Drug Administration (FDA) 510K approval for the highly anticipated Gmate SMART Blood Glucose Monitoring System. The Gmate SMART meter is the size of a quarter and connects to the headphone...

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Targeted Brain Stimulation Aids Stroke Recovery in Mice

August 20, 2014 9:55 am | by Stanford University School of Medicine | Comments

When investigators at the Stanford University School of Medicine applied light-driven stimulation to nerve cells in the brains of mice that had suffered strokes several days earlier, the mice showed significantly greater recovery in motor...

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