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Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume

May 14, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

Curetis AG Achieves CE-Marking for Unyvero Solution and Initiates Commercialization

May 14, 2012 5:15 am | News | Comments

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments...

Study Shows Robotically Enhanced PCI IS Safe and Feasible for Many Patients

May 14, 2012 5:04 am | News | Comments

A robotic system can safely assist interventional cardiologists in performing percutaneous coronary interventions (PCI) while significantly reducing the physician's exposure to radiation and improving precision and control, according to results of the PRECISE study...

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Study of First-in-Class Watchman Device Shows 75% Reduction in Stroke Risk in Patients with Atrial Fibrillation not Eligible for Oral Anticoagulation Therapy

May 14, 2012 4:58 am | News | Comments

Boston Scientific Corporation announces results from the ASA Plavix (ASAP) Study, which studied the WATCHMAN® Left Atrial Appendage Closure (LAAC) device. The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation...

Industry: IRS Needs to Better Define & #8216;Taxable Use & #8217; in Excise Tax Rule

May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Internal Revenue Service guidelines on the 2.3 percent medical device tax should make clear that manufacturers won’t have to pay taxes on products from which they derived no direct benefit, such as demonstration products and replacement parts provided free of charge, AdvaMed said in...

MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely

May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

An omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should...

Researchers Use Light to Switch On Gene Expression

May 10, 2012 10:49 am | News | Comments

Imagine being able to control genetic expression by flipping a light switch. Researchers at North Carolina State University are using light-activated molecules to turn gene expression on and off. Their method enables greater precision when studying gene function, and could lead...

Discovery in cell signaling could help fight against melanoma

May 10, 2012 10:43 am | News | Comments

The human body does a great job of generating new cells to replace dead ones but it is not perfect. Cells need to communicate with or signal to each other to decide when to generate new cells. Communication or signaling errors in cells lead to uncontrolled cell growth...

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iCAD Announces First European Patients Treated with Xoft Radiation Therapy System

May 10, 2012 10:34 am | News | Comments

iCAD, Inc., an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, announced the first European patients have been treated with the Xoft Axxent® Electronic Brachytherapy System.

FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

May 10, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven...

Internal Fixation Systems Enters Into a Distribution Agreement With Intelligent Orthopaedics

May 10, 2012 6:15 am | News | Comments

Internal Fixation Systems announced today that it has entered into a distribution agreement with Intelligent Orthopaedics Ltd. (IO) to market its Staffordshire Orthopaedic Reduction Machine (STORM) which is a reusable device that is used to reduce (align) fractures of the tibia...

Picocell Technology to Enable Faster and More Accurate Diagnoses

May 10, 2012 6:11 am | News | Comments

With demand of high-speed wireless data increasing at astronomical rates, wireless carriers are challenged to find a long-term solution to this escalating issue. According to distinguished members of IEEE, the world's largest professional organization for the advancement of technology...

Portable diagnostics designed to be shaken, not stirred

May 10, 2012 6:09 am | News | Comments

As medical researchers and engineers try to shrink diagnostics to fit in a person's pocket, one question is how to easily move and mix small samples of liquid. University of Washington researchers have built and patented a surface that, when shaken, moves drops along certain paths...

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Automated insulin dosage titration system demonstrates positive clinical study results

May 10, 2012 6:06 am | News | Comments

Newly published results from a clinical study of the Diabetes Insulin Guidance System (DIGS™), under development by Hygieia, Inc., demonstrate DIGS' potential to improve blood glucose control for insulin-using patients with type 2 or type 1 diabetes.

3-D image guided brachytherapy helps avoid hysterectomies for cervical cancer patients

May 10, 2012 6:04 am | News | Comments

Delivering radiotherapy directly to cancer of the cervix using 3-D imaging techniques is effective at controlling the return and spread of the disease and, in most cases, avoids the need for hysterectomies, according to research presented at the World Congress of Brachytherapy today.

Interrad Medical Announces FDA Clearance for Additional Sizes of the SecurAcath Device

May 10, 2012 5:57 am | News | Comments

Interrad Medical, Inc. a privately held medical device company, announced today that it has received FDA clearance for four new sizes of the SecurAcath subcutaneous catheter securement device. In response to requests from clinicians throughout the US, Canada and Europe...

Sorin Group Announces FDA Approval and Commercial Launch of Complete Portfolio of Implantable Heart Device Leads

May 10, 2012 5:54 am | News | Comments

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced today at Heart Rhythm 2012, the Heart Rhythm Society’s 33rd Annual Scientific Sessions, FDA approval and commercial launch for a full portfolio of pacing...

ActiViews, Inc. Announces First Lung Procedure with CT-Guide Needle Guidance System in the U.S.

May 10, 2012 5:53 am | News | Comments

ActiViews, Inc, a company pioneering the development of simple, accurate, and cost-effective surgical navigation solutions, announced today the first successful procedure in the United States with CT-Guide™ navigation. The procedure was performed by Sebastian Flacke, M.D., Ph.D...

Eliminate Unwanted, Stubborn Belly Fat: Revolutionary CoolSculpting Procedure Receives FDA Clearance to Treat Abdomen Area

May 10, 2012 5:50 am | News | Comments

Welcome relief for millions of men and women dealing with one of the most exercise and diet-resistant problem areas – “belly fat” – as CoolSculpting, developed by ZELTIQ® Aesthetics, Inc., a medical technology company, is now cleared by the U.S. FDA...

Nitto Denko Obtains US Patent for Antifibrotic Therapies with Molecular Targeting DDS Technology

May 10, 2012 5:48 am | News | Comments

Japan's leading diversified materials manufacturer, Nitto Denko Corporation, today announced that a basic patent regarding the company's epoch-making antifibrotic therapy has been successfully registered in the USA. Nitto Denko has been developing antifibrotic drugs...

Biosense Webster Announces Launch of the THERMOCOOL SF NAV Catheter With Curve Visualization

May 10, 2012 5:45 am | News | Comments

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the launch of the new THERMOCOOL® SF NAV irrigated ablation catheter with Curve Visualization in the United States.

Pediatric X-ray Imaging

May 10, 2012 1:30 am | by U.S. Food & Drug Administration | News | Comments

Medical imaging has led to improvements in the diagnosis and treatment of numerous medical conditions in children and adults. There are many types - or modalities - of medical imaging procedures that are used on children, each of which uses different...

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

May 10, 2012 1:30 am | by U.S. Food & Drug Administration | News | Comments

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging...

Public Workshop - Device Improvements for Pediatric X-ray Imaging, July 16, 2012

May 9, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

The main purpose of the workshop is to discuss the draft guidance Pediatric Information for X-ray Imaging Device Premarket Notifications. This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and...

Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications

May 9, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

This guidance document outlines the FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. The Agency intends for this guidance to minimize...

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