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NDC Implements Voluntary Recall of Guidewire

June 19, 2014 9:41 am | by FDA | Nitinol Devices & Components, Inc. | News | Comments

Nitinol Devices & Components, Inc. (NDC) announced today a voluntary recall of its HydroFinity Hydrophilic Guidewires. The HydroFinity Guidewire is a product developed and manufactured by NDC and distributed by Covidien. It is a nitinol...

St. Jude’s Leadless Pacemaker Receives Prestigious Innovation Award

June 18, 2014 4:03 pm | by St. Jude Medical Inc. | News | Comments

St. Jude Medical Inc., a global medical device company, today announced the Nanostim leadless pacemaker was awarded the 2014 Innovation Award at Cardiostim 2014, the 19th World Congress in Cardiac Electrophysiology and Cardiac Techniques...

Professor Develops Verification Tool for Trustworthy Cyber-Physical Systems

June 18, 2014 12:02 pm | by Kim Gudeman, CSL | News | Comments

Over the past few decades, information systems have increasingly replaced human operators and processes, with technology assisting in everything from flying aircraft to regulating heartbeats. As the movement toward more autonomous systems...

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Collaboration Aims to Accelerate Biomedical Research Innovations into the Marketplace

June 18, 2014 11:35 am | by National Institutes of Health | News | Comments

A collaboration between the National Science Foundation (NSF) and the National Institutes of Health will give NIH-funded researchers training to help them evaluate their scientific discoveries for commercial potential, with the aim of accelerating...

MedTech Prices Lag Behind CPI, Other Medical Goods

June 18, 2014 11:11 am | by AdvaMed | News | Comments

Medical technology prices continue their trend of consistently low growth, increasing at approximately one-third the rate of prices in the overall economy and one-fifth the rate of prices for other medical goods and services over a 23-year...

Cardiopad Brings Heart Health to Remote Cameroon Communities

June 17, 2014 10:37 am | by Reuters | Videos | Comments

A touch screen tablet invented by a 22-year-old Cameroonian engineer is helping doctors perform heart examinations on patients in remote, rural locations beyond the reach of specialists...          

Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis

June 17, 2014 9:50 am | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

At FDA’s medical devices center, we have a vision — it’s what we strive for each day in our review and assessment of new medical technology. And patients are at the very core of that vision: “Patients in the U.S. have access to high-quality...

Edwards Lifesciences Launching SAPIEN XT Valve in the U.S.

June 16, 2014 6:29 pm | by PR Newswire | News | Comments

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, has announced that it has received United States Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT...   

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Unleashing Clinical Measurements

June 16, 2014 2:38 pm | by Angelo Corsaro, Ph.D., Chief Technology Officer, PrismTech | Blogs | Comments

Medical devices are an essential element of modern medicine as they provide accurate clinical measurements such as oxygen saturation, blood pressure and temperature, x-ray and ultrasound imaging, as well as automatically administer intravenous...

BIOTRONIK Presents New Heart Stimulator at Cardiostim Conference

June 16, 2014 11:37 am | by PresseBox | News | Comments

BIOTRONIK, a leading manufacturer of cardiovascular medical technology, is presenting its new heart stimulator at the Cardiostim 2014 electrophysiology and cardiology congress. With a market-leading position in Europe, BIOTRONIK's cardiac...

How to Market Your Device

June 16, 2014 9:34 am | by U.S. Food & Drug Administration | News | Comments

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299... 

Medtronic to Buy Covidien

June 16, 2014 9:10 am | by Josh Boak, AP Business Writer | News | Comments

U.S. medical device manufacturer Medtronic has agreed to buy Ireland-based competitor Covidien for $42.9 billion in cash and stock. The combined company would have its executive offices in Dublin, where it could benefit from Ireland's lower...

Medtronic Heart Valve Approved for Broader Use

June 13, 2014 11:14 am | by The Associated Press | News | Comments

Medtronic Inc. said Thursday that the FDA approved its artificial heart valve, CoreValve, for use in more patients who face serious risks from open-heart surgery, the standard treatment. Medtronic's implant is a less invasive approach to...

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Panel Provides Unanimous Favorable Recommendation to FDA for Bard's Drug Coated Balloon

June 12, 2014 8:28 pm | by The Associated Press | News | Comments

C. R. Bard, Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter (DCB)...

Poor Cardiovascular Health Linked to Memory, Learning Deficits

June 12, 2014 12:14 pm | by American Heart Association | News | Comments

The risk of developing cognitive impairment, especially learning and memory problems, is significantly greater for people with poor cardiovascular health than people with intermediate or ideal cardiovascular health, according to a study in the Journal of the American Heart Association. Cardiovascular health plays ...

Blood Product Sterilization Taken too Far?

June 12, 2014 11:11 am | by Jean-François Huppé, Université Laval | News | Comments

Certain processes used to sterilize blood products could potentially cause serious health issues in transfusion recipients, according to an international study published in the journal Platelets and led by Dr. Patrick Provost of Université Laval's Faculty of Medicine and the CHU de Québec Research Center. These processes ...

The Quest for Long-Lasting Blood

June 11, 2014 4:10 pm | by University of Essex | News | Comments

Haemoglobin is the key protein in red blood cells that carries oxygen around our bodies. The Haem02 team aim to create an artificial haemoglobin-based oxygen carrier (HBOC) that could be used as a substitute for blood lost in ...    

Ohio State First to Implant Newly-Approved Wireless Heart Failure Monitor

June 10, 2014 4:03 pm | by Ohio State University Wexner Medical Center | News | Comments

Doctors at The Ohio State University Wexner Medical Center are the first in the country to begin treating some heart failure patients with a new wireless, implantable hemodynamic monitor that was just approved by the U.S. Food and Drug Administration. The monitor will ...

First Patient Receives HeartAssist5 VAD Following CE Mark Approval

June 9, 2014 5:23 pm | by ReliantHeart | News | Comments

Privately-held ReliantHeart, a leading innovator in mechanical circulatory support therapies, announced the first advanced stage heart failure patient received its next generation HeartAssist5 Ventricular Assist Device (VAD) since the company...

Hansen Medical's Sensei X Robotic Catheter System to Be Featured at Cardiostim Congress

June 9, 2014 10:28 am | by The Associated Press | News | Comments

Hansen Medical, Inc., a global leader in intravascular robotics, will showcase its new Sensei X2 Robotic System prototype at Cardiostim Congress from June 18 - 21 at the Acropolis Convention Center in Nice, France. The Sensei X2 features...

Medical Robotics and Computer-Assisted Surgery Markets to Reach $4.6 Billion in 2019

June 9, 2014 10:25 am | by BCC Research | News | Comments

According to a new report from BCC Research, the global market for medical robotics and computer-assisted surgical (MRCAS) technologies is expected to grow to $4.6 billion by 2019, with a five-year compound annual growth rate (CAGR) of 7%...

The Quest for Long-Lasting Blood

June 9, 2014 8:58 am | by University of Essex | News | Comments

A team of scientists at the University of Essex are hoping to develop a one-size-fits-all, third generation artificial blood substitute. Every day thousands of people around the world have their lives saved or improved thanks to someone...

Photos of the Day: Life-Saving Shirt

June 9, 2014 8:51 am | by Johns Hopkins | News | Comments

Johns Hopkins biomedical engineering students have designed a lightweight, easy-to-conceal shirt-like garment to deliver life-saving shocks to patients experiencing serious heart problems. The students say their design improves upon a wearable...

Heart-Shocking ‘Shirt’ May Save Lives when Paramedics Are Not Nearby

June 9, 2014 8:51 am | by Johns Hopkins | News | Comments

Johns Hopkins biomedical engineering students have designed a lightweight, easy-to-conceal shirt-like garment to deliver life-saving shocks to patients experiencing serious heart problems. The students say their design improves upon a wearable...

Shifamed Introduces Coaxial Steerable Catheter Technology In 4 Fr Size

June 9, 2014 7:27 am | by PR Newswire | News | Comments

Shifamed LLC, a medical technology incubator, today announced that it will formally introduce its patented coaxial steerable catheter technology in 4 Fr size at MD&M East on June 10-12, 2014 at the Jacob K. Javits Convention Center, New...

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