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An Electric Therapy for Medical-Device Malware

August 9, 2013 12:00 am | by Massachusetts Institute of Technology | News | Comments

Hospital rooms beep and flash with many devices that are increasingly getting infected with malware. But for several reasons, these gadgets are often incompatible with commercial security software. Now, new technology developed by academic researchers could catch most malware on the devices just by noting subtle changes in their power consumption.

Cordis recall of Optease vena cava filter is Class I

August 8, 2013 12:01 pm | by Mass Device | News | Comments

The recall last March of Johnson & Johnson unit Cordis Corp.'s Optease vena cava filter is Class I, according to the FDA, meaning the device could cause serious injury or death. Cordis notified healthcare providers March 29 about 33,000 Optease devices, on concerns that they could be implanted backwards, according to the FDA.

Levine Leichtman Acquires Champion Manufacturing

August 8, 2013 11:37 am | by PR Newswire | News | Comments

Levine Leichtman Capital Partners ("LLCP"), a Los Angeles-based private equity firm, announced today that it has partnered with management to complete the acquisition of Champion Manufacturing, Inc. ("Champion"), a subsidiary of Invacare Corporation. 

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How Can Formula 1 Racing Help ... Babies?

August 8, 2013 10:39 am | by TED | Videos | Comments

During a Formula 1 race, a car sends hundreds of millions of data points to its garage for real-time analysis and feedback. So why not use this detailed and rigorous data system elsewhere, like ... at children’s hospitals?     

The Pulse: MRI-Safe Stimulator Implanted

August 8, 2013 10:27 am | by Eric Sorensen, Coordinator of Multimedia Development | Videos | Comments

Welcome to the Pulse, brought to you by MDT TV. Today, we're implanting an MRI-safe spinal cord stimulator, sorting blood with a microchip, building robots out of biocompatible hydrogel, and making hydrogel move with light.           

Over 50% of U.S. News & World Report's "Best Heart Hospitals" Are Certified to Implant the SynCardia Total Artificial Heart

August 8, 2013 8:45 am | by PR Newswire | News | Comments

SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that over half of the top 50 centers honored in U.S. News & World Report's "Best Hospitals" list for cardiology and heart surgery for 2013-2014, offer the SynCardia temporary Total Artificial Heart.

Class I Medical Device Recall: Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter

August 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Optease Retrievable Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter.

Cook Medical gets its Zilver PTX back on the market

August 7, 2013 2:25 pm | by Mass Device | News | Comments

Three months after the recall of its Zilver PTX peripheral stent, Cook Medical has the device back on the market across the globe. Rob Lyles, vice president and global leader of Cook’s peripheral intervention business, told MassDevice.com today that the FDA cleared the device to go back on the U.S. market July 25.

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Bioprinting: From Concept to Reality

August 7, 2013 2:24 pm | by Stephen L. Pentoney Jr., PhD, MBA, and Sharon C. Presnell, PhD, Organovo | Articles | Comments

The field of Tissue Engineering, an interdisciplinary field focused on building or regenerating functional three-dimensional tissues, has deployed several fabrication strategies aimed at bringing cells and structure together to generate tissue.  

MedNet Solutions Partners With Heart Imaging Technologies

August 7, 2013 2:17 pm | by PR Newswire | News | Comments

MedNet Solutions, a global life sciences technology company specializing in clinical study management systems, and Heart Imaging Technologies (Heart IT), an industry leader in web-based medical image viewing and management solutions, are pleased to announce their strategic partnership and the integration of Heart IT's WebPAX® technology with MedNet's eClinical solutions.

Labeling glitch with Boston Scientific's Promus Element Plus prompts recall in Australia

August 7, 2013 12:01 pm | by Mass Device | News | Comments

Boston Scientific shipped some of its Promus Element Plus Monorail coronary stents with the wrong labels in Australia, prompting that country's Therapeutic Goods Administration to issue a recall. The Promus stents were shipped with incorrect directions for use Down Under, according to a TGA release.

Minimally Invasive Stents Show Some Advantage over Bypass in Opening Blocked Leg Arteries

August 7, 2013 10:55 am | by Johns Hopkins Medicine | News | Comments

New Johns Hopkins research suggests that people who undergo minimally invasive placement of stents to open clogged leg arteries are significantly less likely than those who have conventional bypass surgery to need a second treatment for the condition within two years.

Diamond-Based Lasers for Healthcare

August 7, 2013 10:36 am | by Engineering and Physical Sciences Research Council | News | Comments

Ground-breaking research is harnessing the unique properties of diamonds to develop a new generation of lasers that could lead to many benefits, from better treatment of skin complaints and diabetes-related eye conditions to improved pollution monitoring and aeronautical engineering.

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Commonly Used Catheter's Safety Tied to Patient Population

August 6, 2013 12:11 pm | by Society for Healthcare Epidemiology of America | News | Comments

A new study reports that peripherally inserted central catheters (PICCs) do not reduce the risk of central line associated bloodstream infections (CLABSIs) in hospitalized patients. PICCs have become one of the most commonly used central venous catheters (CVCs) in healthcare settings since they are considered easier and safer to use, with less risk of CLABSIs.

CorMatrix Cardiovascular Receives Three Patents for Biomaterial Heart Valve

August 6, 2013 10:43 am | by Business Wire | News | Comments

CorMatrix Cardiovascular, a leading medical device developer, today announced the receipt of three U.S. Patents for replacement heart valves that utilize unique biomaterial called extracellular matrix (ECM). The established leader in cardiac biomaterial, CorMatrix has more than 120 U.S. and international patent applications pending on various ECM-based compositions and structures.

Light that Moves and Molds Gels

August 5, 2013 12:47 pm | by University of Pittsburgh | News | Comments

Some animals—like the octopus and cuttlefish—transform their shape based on environment, fending off attackers or threats in the wild. For decades, researchers have worked toward mimicking similar biological responses in non-living organisms, as it would have significant implications in the medical arena.

TAVI: Edwards wins FDA approval to begin clinical studies of next-gen Sapien 3 valve

August 5, 2013 12:29 pm | by Mass Device | News | Comments

Medical device giant Edwards Lifesciences is powering forward with its solo-hold on the U.S. market for transcatheter aortic valve implantation systems, now preparing to launch an Investigational Device Exemption clinical trial of its next-generation Sapien 3 TAVI device.

Cardiologist must cough up $17M in false Medicare billing case

August 2, 2013 1:13 pm | by Mass Device | News | Comments

A Washington, D.C., cardiologist was hit with a $17 million judgment after being found guilty of submitting false claims for nuclear imaging tests to Medicare and state health programs. Federal authorities accused Dr. Ishtiaq Malik of double-billing and submitting false claims for myocardial perfusion studies or "nuclear stress tests."

Abiomed Surpasses 15,000 Impella Patients in the United States

August 2, 2013 8:45 am | by Globe Newswire | News | Comments

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today reported that physicians have implanted more than 15,000 Impella® pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General Hospital in Sacramento, California with an Impella pump that provided prophylactic circulatory support.

Thubrikar’s Next-Generation TAVI system surpasses ISO requirement for durability and achieves other milestones

August 1, 2013 6:27 pm | by Business Wire | News | Comments

Thubrikar Aortic Valve, a privately held medical device company developing a next-generation transcatheter aortic valve implantation (TAVI) system, announced today that its Optimum TAV has surpassed 200 million cycles in an ongoing durability test - which simulates over 5 years in humans and meets the requirement set by the International Organization for Standardization (ISO) - in a third party GLP study.

FDA expands clearance for Teleflex's Arrow balloon dilatation catheters

August 1, 2013 1:29 pm | by Mass Device | News | Comments

Teleflex (NYSE:TFX) won FDA clearance for expanded sizes and uses of its Arrow GPSCath Balloon Dilatation catheter, a device the company picked up during the 2012 buyout of Hotspur Technologies. The FDA win lets Teleflex sell the catheter in new 80 cm lengths and in a higher burst pressure rating.

Camera Crushes Patient; Sparks Recall

August 1, 2013 12:40 pm | by David Mantey, Executive Editor, MDT | News | Comments

This week, the U.S. Food and Drug Administration (FDA) announced the recall of GE Healthcare’s Nuclear Medicine Systems were recalled following an incident at a VA Medical Center in which a patient died due to injuries sustained while being scanned.

Solutions for Improving First Aid in Cardiorespiratory Arrests

July 31, 2013 11:52 am | by Elhuyar Fundazioa | News | Comments

An algorithm capable of diagnosing heart rhythm with just 3 seconds’ worth of signal, and the demonstration that it is possible to come up with the diagnosis without stopping cardiac massage, constitute the types of solutions and proposals being developed by researchers in the Signal and Communications Group of the Faculty of Engineering in Bilbao.

Stem Cells in Urine Easy To Isolate and Have Potential for Numerous Therapies

July 31, 2013 10:12 am | by Wake Forest Baptist Medical Center | News | Comments

Could harvesting stem cells for therapy one day be as simple as asking patients for a urine sample? Researchers at Wake Forest Baptist Medical Center's Institute for Regenerative Medicine and colleagues have identified stem cells in urine that can be directed to become multiple cell types.

Teleflex Receives FDA Clearance for ARROW GPSCath Balloon Dilatation Catheters in Higher RBP and 80 cm Lengths

July 30, 2013 5:00 pm | by Business Wire | News | Comments

Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced that its subsidiary Hotspur Technologies, Inc., which Teleflex acquired in June 2012, received FDA 510(k) clearance to market the company’s ARROW ® GPSCath ® Balloon Dilatation Catheters in Higher Rated Burst Pressure (RBP) and 80 cm lengths.

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