WAUWATOSA, Wis.--(BUSINESS WIRE)--March 13, 2009--Medical testing meets medical “texting” with the US Food and Drug Administration clearance of GE Healthcare’s latest ECG (electrocardiogram) solution, the portable MAC 800, based on cell phone technology. Targeting physician’s offices and the pharmaceutical industry, GE’s entry into the portable ECG market is as practical as it is innovative.
Originally developed and introduced in China, for China in 2008, the lightweight portable device combines the keypad of a phone with a full-size color display and world-class diagnostic software to help clinicians shape the future of healthcare in regions across the world.
Full text >> http://www.reuters.com/article/pressRelease/idUS111212+13-Mar-2009+BW20090313
Friday, March 20, 2009
GE’s First Portable ECG, “Medical Texting,” Arrive in US
Olympus Medical Systems in Collaboration with Medinol Ltd. Announces the Release of the X-Suit NIR(R), a Biliary Metallic Stent
Expanding the Business of EndoTherapy Devices Through the Metallic Stent Market in Europe, the US and Parts of Asia
HAMBURG, Germany--(HSMN NewsFeed)--Olympus Medical Systems Corporation, in collaboration with Medinol Ltd., announces the release of the X-Suit NIR(R), a biliary metallic stent featuring exceptional anatomic conformability. This device will launch in Europe and parts of Asia on March 27, 2009 followed by the US on April 24, 2009. In Japan and other territories the product will be launched after obtaining marketing approval from the regulatory authorities. The president of Olympus Medical Systems Corporation, Haruhito Morishima, declared: “I am pleased to announce that we will soon be launching a new metallic stent which is an essential component of endoscopic treatment for biliary duct lesions. This product is the fruit of years of groundwork in collaboration with an Israeli company, Medinol. The product offers both excellent radial force and flexibility, which are crucial requirements for the stents. We can confidently recommend this high-quality stent system to our customers.”
Press release >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027577
LUMEDX Launches New Interventional Radiology Software
IR Solution for Electronic Procedure Records, Billing and Inventory, and JCAHO Compliance
OAKLAND, Calif., March 19 (HSMN NewsFeed) -- LUMEDX Corporation, a leading provider of fully integrated medical imaging and information systems, introduces new software to collect interventional radiology procedural information at the point of care: http://www.lumedx.com/IR/
Delivering comprehensive data capture for both general and vascular procedures, the Interventional Radiology module automatically documents JCAHO and patient safety performance measures. This new solution is the first commercial software to offer sophisticated, integrated tools for this vital service line, and was designed to meet hospitals' clinical--and business--objectives.
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Harvard Study Favors Cayenne Medical's AperFix Technology for Reconstruction of Torn ACL
"Single-Tunnel, Double-Bundle" Technique Shown to More Closely Resemble Intact ACL than "Single-Bundle" Technique
BOSTON--(HSMN NewsFeed)--Cayenne Medical, Inc., a privately held sports medicine company based in Scottsdale, announced today that a new Harvard clinical study published in the American Journal of Sports Medicine (AJSM) found that Cayenne’s AperFix(R) System and "Single Tunnel, Double Bundle™" ACL reconstruction technique better resembles the natural, intact ACL when compared to the more common, "Single-Bundle" technique.
The study, titled "Biomechanical Comparison of Single-Tunnel, Double-Bundle and Single-Bundle Anterior Cruciate Ligament Reconstructions," appears in the current issue of AJSM and was authored by Hemanth R. Gadikota, MS, Jong Keun Seon, MD, Michal Kozanek, MD, Luke S. Oh, MD, Thomas J. Gill, MD, and Guoan Li, PhD, all from the Department of Orthopaedic Surgery at Massachusetts General Hospital and Harvard Medical School; and Kenneth D. Montgomery, MD, of Tri-County Orthopaedic & Sports Medicine in Morristown, New Jersey.
Breast-Specific Gamma Imaging (BSGI) Can Reduce the Number of Unnecessary Breast Biopsies When Compared to MRI
Pivotal Study Presented at Interdisciplinary Breast Center Conference
NEWPORT NEWS, Va., March 18 (HSMN NewsFeed) -- Women that require additional diagnostic imaging after a questionable mammogram may be at risk for unnecessary biopsies when only magnetic resonance imaging (MRI) is offered, according to a new study presented at the 19th Annual National Interdisciplinary Breast Center Conference in Las Vegas.
"Our goal was to see if BSGI could be used to improve upon the specificity of MRI, and also reduce the number of biopsies. The study is important because with the addition of BSGI, we could eliminate the need for 50 percent of biopsies or possibly change a patient's decision to have more radical surgery," said Dr. Leora Lanzkowsky, Director of Women's Imaging, CHW - Nevada Imaging Centers in Las Vegas.
Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027562
Flexible Stenting Solutions, Inc. Announces IDE Submission for FlexStent(R) Femoropopliteal Self Expanding Stent System
EATONTOWN, N.J.--(HSMN NewsFeed)--Flexible Stenting Solutions Inc. (“FSS”), a leading developer of next generation peripheral arterial stents has submitted an Investigational Device Exemption (IDE) application to the FDA for its FlexStent(R) Femoropopliteal SE Stent System for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries. This next generation femoropopliteal stent and delivery system can significantly improve patient care in the high growth peripheral vascular segment.
While stent procedures have become widespread in the treatment of coronary arterial disease, their use in the more challenging peripheral vascular disease setting had been limited in the last several years by inadequate stent design. The fully connected flexible FlexStent(R) has coupled technology with clinical needs by providing a highly durable and fatigue resistant stent. The FlexStent(R) has superior radial stiffness, as well as excellent conformability to and mobility with the treated vessel. The delivery system provides simplicity, ease-of-use and accurate, uniform stent placement for the vascular interventionalist.
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Edwards Lifesciences Completes Enrollment in Non-Surgical Study Arm of U.S. Clinical Trial for Transcatheter Valve
IRVINE, CA--(HSMN NewsFeed)--Mar 17, 2009 -- Edwards Lifesciences Corporation (NYSE:EW ), the world leader in the science of heart valves, today announced completion of enrollment in the 350-patient non-surgical study arm of its U.S. pivotal trial -- known as the PARTNER Trial -- for the Edwards SAPIEN transcatheter aortic heart valve.
"Reaching this milestone is a significant achievement for the subset of patients suffering from severe aortic stenosis who can't tolerate conventional aortic valve replacement. Without a transcatheter heart valve, they have no definitive treatment options for addressing their valve disease," said Craig Smith, M.D., interim surgeon-in-chief and chief of cardiothoracic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons, and co-principal investigator for the trial.
Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027554
OrbusNeich Files Patent Infringement Lawsuit Against Boston Scientific
FT. LAUDERDALE, Fla. and HONG KONG, March 16 (HSMN NewsFeed) -- OrbusNeich Medical, Inc. ("Orbus" or the "Company"), a designer, developer, manufacturer and marketer of innovative medical devices for the treatment of vascular diseases, today announced that it has filed a lawsuit against Boston Scientific Corporation ("BSC"). The lawsuit, filed in the United States District Court for the Eastern District of Virginia, asserts claims against BSC for patent infringement, breach of contract and for misappropriation of trade secrets. The suit seeks unspecified monetary damages and injunctive relief in connection with its claims.
Orbus is the owner by assignment of all right, title, and interest in U.S. Patent No. 7,329,277 entitled "Stent Having Helical Elements" and U.S. Patent No. 6,821,292 entitled "Crimpable Intraluminal Endoprosthesis Having Helical Elements." In its complaint Orbus alleges, among other things, that BSC has infringed these two Orbus patents relating to its proprietary luminal stent technology.
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Cordis Corporation Announces Head-to-Head Randomized Clinical Trial Comparing the NEVO Sirolimus-Eluting Coronary Stent to the XIENCE Stent
BRIDGEWATER, N.J.--(HSMN NewsFeed)--Cordis Corporation, a worldwide leader in the field of interventional cardiology, announced plans today to launch a global, head-to-head, randomized clinical trial called NEVO II which will compare the NEVO(TM) Sirolimus-eluting Coronary Stent to the XIENCE V(TM) Everolimus-eluting Coronary Stent. Cordis Corporation and Conor Medsystems, LLC are sponsors of the study. NEVO(TM) is the first and only drug-eluting stent utilizing a unique reservoir (RES) technology, which Cordis acquired from Conor Medsystems, LLC in 2007, and incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This revolutionary design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and becomes fully bare metal following drug delivery and polymer bioresorption in approximately three months.
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CytRx's Arimoclomol Demonstrates Statistically Significant Neurorestorative Results in a Preclinical Embolic Stroke Trial
Data Supports Previous Preclinical Results Indicating Improvement in Stroke Recovery Following Oral Arimoclomol Administration
LOS ANGELES--(HSMN NewsFeed)--CytRx Corporation (NASDAQ:CYTR ), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced data from an animal stroke trial indicating that treatment with its molecular chaperone amplifier drug candidate, arimoclomol, initiated at either six, 10, 24 or 48 hours post-stroke, demonstrated neurorestorative ability based on multiple behavioral tests measuring motor and sensory recovery.
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New Clinical Study Finds Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Accurate in the Noninvasive Monitoring of Fluid Status During Surgery
UCSF Researchers Presented Study Data Demonstrating the Unique Ability of Masimo PVI(TM) to Reflect Acute Changes in Intravascular Fluid Volume at the International Anesthesia Research Society 83rd Scientific Congress
IRVINE, Calif.,, March 16 (HSMN NewsFeed) -- Masimo (Nasdaq: MASI ), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low-Perfusion pulse oximetry, today announce that a new clinical study, independently conducted by researchers from the University of California-San Francisco (UCSF), demonstrates that Masimo PVI accurately and reliably reflects acute changes in intravascular fluid volume (preload).(1) The study, presented at the International Anesthesia Research Society (IARS) 83rd Scientific Congress on March 14th in San Diego, Calif., affirms PVI as a highly predictive indicator of patient fluid status.
Assessing whether a patient needs fluid to increase their cardiac index (amount of blood the heart pumps each minute) is one of the biggest challenges anesthesiologists face during surgery. Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality(2) and traditional invasive measurements are only 50 to 60% accurate at predicting improvement in cardiac index after volume administration.(3) PVI--a new method for noninvasive and automatic assessment of fluid responsiveness--has been shown in multiple studies to predict fluid responsiveness in mechanically ventilated patients, helping clinicians to optimize fluid administration and improve patient outcomes.(4-6)
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