Premier Healthcare Alliance awarded several new contracts for drug-eluting stents, traditional stents and other intervention products to 8 heavy hitters in the cardiology space. Abbott, Boston Scientific, and Medtronic all landed supplier deals for drug-eluting and traditional stents.
Meeting Notice: September 11-12, 2013 Circulatory System Devices Panel of the Medical Devices Advisory CommitteeAugust 13, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
On September 11, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of external cardiac compressor (ECC) devices, one of the remaining preamendments class III devices regulated under the section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) (510(k)) pathway.
Medicomp, Inc. introduces the SAVI Air, the only Wireless Event Monitor to offer beat-to-beat analysis of the entire ECG, a patented feature previously unavailable to healthcare. Prior to the release of the SAVI Air, wireless event monitors relied on algorithms that could only analyze limited aspects of the ECG, therefore increasing the risk of missing significant arrhythmias.
Abbott’s investigational Absorb™ Bioresorbable Vascular Scaffold was recently named one of R&D Magazine’s 2013 top 100 technologies as part of its 51st annual R&D 100 Awards. Absorb joins a number of innovative technologies being honored by the awards, which recognize the 100 most technologically significant products introduced into the marketplace over the past year.
Former President George W. Bush’s recent heart stent operation will further increase the popularity of what is often an unnecessary and wasteful procedure, says an analyst with research and consulting firm GlobalData. The ex-US President received a stent to prop open a clogged coronary artery on Tuesday morning, following a regularly scheduled visit to his doctor.
Surgery to relieve the damaging pressure caused by hemorrhaging in the brain is a perfect job for a robot. That is the basic premise of a new image-guided surgical system under development at Vanderbilt University. It employs steerable needles about the size of those used for biopsies to penetrate the brain with minimal damage and suction away the blood clot that has formed.
Surviving sudden cardiac arrest depends largely on the people around you and easy access to an automated defibrillator, or AED. It turns out that the gym is the best indoor location for cardiac arrest victims' survival chances, likely because of the increased presence of AEDs and well-placed instruction manuals.
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.
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 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.
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?
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 HeartAugust 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.
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.
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.
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, 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.
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.
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.
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.
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, 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.
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.
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.
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."