The Endurant AAA stent graft system from Medtronic, Inc. continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up.
GE Healthcare Announces Commercial Availability of New Methodology That Provides a Cancer Profile on a Single SlideMay 31, 2013 9:00 am | by Business Wire | News | Comments
GE Healthcare today announced at the 2013 Annual Meeting of the American Society of Clinical Oncology its plans for the commercialization of MultiOmyx ™, a ground-breaking new pathology platform, using proprietary methodology to analyze multiple proteins at a single-cell level.
Medtronic, Inc. (NYSE: MDT) is expanding its market-leading portfolio of products for endovascular aortic repair in the United States with two new medical devices: the company recently received approval from the U.S. Food and Drug Administration (FDA) for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA’s 510(k) clearance for the Sentrant Introducer Sheath.
GE Healthcare, the healthcare division of General Electric (NYSE: GE), announced today the acquisition of Unisyn Medical Technologies’ Transactional Business, a leading national provider of comprehensive ultrasound probe repair solutions to biomedical and clinical engineers, headquartered in Golden, CO. Financial terms were not disclosed.
The technology at the heart of the next generation of medical devices is critical to our ability to offer comprehensive care in the coming decades. While our current systems of care have served us well thus far, they are crumbling under the pressures of modern expectations of care, economics, scale, and the sheer breadth of medical science.
Covidien Nellcor Pulse Oximeters Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart DiseaseMay 28, 2013 12:35 pm | by Covidien | News | Comments
Covidien’s new CCHD labeling was introduced as part of the FDA 510(k)-cleared labeling for motion tolerant Nellcor pulse oximeters. In 2011, the U.S. Department of Health and Human Services added CCHD screening to the Federal Recommended Uniform Screening Panel Guidelines.
GE Healthcare (NYSE: GE) has introduced MAVRIC SL, a novel magnetic resonance (MR) imaging technique designed to address the growing clinical need to more accurately image soft tissue and bone in patients with MR Conditional-labeled implants, such as joint replacements and other instrumentation.
Medtronic Completes Enrollment in Landmark U.S. Study of Symplicity Renal Denervation System for Treatment-Resistant HypertensionMay 23, 2013 6:06 am | by The Associated Press | News | Comments
Medtronic, Inc., today announced it has finished randomizing Symplicity HTN-3, the company's pivotal U.S. clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension. Renal denervation is a minimally invasive, catheter-based procedure to reduce activity of the renal (kidney) nerves, which are part of the sympathetic nervous system and help regulate blood pressure.
One Year Data from St. Jude Medical Study Demonstrates Safe, Rapid and Sustained Blood Pressure Reduction with EnligHTN Renal Denervation TechnologyMay 23, 2013 4:15 am | by The Associated Press | News | Comments
ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 23, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s EnligHTN ™ Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after...
New Data Demonstrate Significant And Sustained Blood Pressure Reduction With Boston Scientific Vessix™ Renal Denervation SystemMay 22, 2013 12:20 pm | by PR Newswire | News | Comments
PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today reported interim data from the REDUCE-HTN clinical program, which demonstrated a significant and sustained reduction in the blood pressure of patients treated with the Vessix™ Renal Denervation...
NEW YORK--(BUSINESS WIRE)--May 22, 2013--Wendy Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that the firm issued today a list of answers to frequently asked questions (FAQ) from hip replacement patients who received the Stryker Rejuvenate or...
St. Jude Medical EnligHTNment Study Highlighted at EuroPCR During Trials That May Change Clinical Practice SessionMay 21, 2013 9:52 am | by The Associated Press | News | Comments
ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--May 21, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the start of its landmark EnligHTNment clinical study. This is the largest randomized, prospective trial to determine whether renal denervation and...
Covidien’s Technology Platform to Diagnose Early Lung Cancer Part of New Guidelines of American College of Chest PhysiciansMay 21, 2013 6:59 am | by The Associated Press | News | Comments
MINNEAPOLIS--(BUSINESS WIRE)--May 21, 2013--Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that its superDimension Electromagnetic Navigation Bronchoscopy (ENB™) system, the first technology of its kind, is included in the new American College of Chest...
Medtronic Finds TAVI with CoreValve System Cost Effective for Treating Patients with Severe Aortic StenosisMay 21, 2013 4:06 am | by The Associated Press | News | Comments
Focused on offering devices that provide both clinical and economic value, Medtronic, Inc. unveiled the results of a cost-effectiveness model comparing transcatheter aortic valve implantation with the CoreValve System to medical management. Presented at EuroPCR 2013, the United Kingdom-based analysis compared the "real world" Medtronic CoreValve ADVANCE study to the medical management cohort of the PARTNER B study.
Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced that its Nellcor™ pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for motion claims.
NISKAYUNA, N.Y.--(BUSINESS WIRE)--May 20, 2013--To commemorate National Cancer Research Month, a team of scientists from GE Global Research, the technology development arm of the General Electric Co. (NYSE: GE), are joined together in a technology “relay race” against cancer. They collectively are...
Expanding its portfolio of medical technology for the interventional treatment of cardiovascular disease, Medtronic, Inc. (NYSE: MDT) announced today that the Export Advance aspiration catheter recently received the CE (Conformité Européenne) mark and will soon be launched in Europe and other international markets.
Legal-Bay LLC, the Lawsuit Settlement Funding Company, has issued an update on two major hip implant litigations in the mass tort market. And the results are completely different. Legal-Bay believes the Stryker hip litigation on the ABG II and the Rejuvenate which have been already recalled by the company will see a smoother road for plaintiffs looking for a settlement in the not so distant future.
At an event held at Hospital for Special Surgery, GE Healthcare introduced MAVRIC SL, a novel magnetic resonance imaging technique designed to address the growing clinical need to more accurately image soft tissue and bone in patients with MR Conditional-labeled implants, such as joint replacements and other instrumentation.
Stryker's Sustainability Solutions division announced today it has received two prestigious awards from the group purchasing organization Novation for supplier excellence. Novation named Stryker's reprocessing division Purchased Services Supplier of the Year and presented it with top honors in...
St. Jude Medical Announces First Patient Enrollment in EnligHTN III Renal Denervation Study of Next-Generation EnligHTN SystemMay 14, 2013 8:00 am | by The Associated Press | News | Comments
ST. PAUL, Minn.--(BUSINESS WIRE)--May 14, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced enrollment of the first patient in the EnligHTN III trial. This study will evaluate the safety and performance of the new second-generation EnligHTN ™ Renal...
Medtronic has announced new data demonstrating that simultaneously pacing the lower chambers of the heart, or biventricular (BiV) pacing with a cardiac resynchronization therapy (CRT) device, significantly improves heart failure symptoms and quality of life in a subset of heart failure patients.
Data Show Medtronic-Exclusive LIA Software Detects Non-Medtronic Lead Issues at a Greater Rate Than Standard Impedance MonitoringMay 10, 2013 4:06 pm | by The Associated Press | News | Comments
MINNEAPOLIS and DENVER - May 10, 2013 - Data presented today at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions, show that Medtronic, Inc. (NYSE:MDT) Lead Integrity Alert (LIA) software detected pace/sense lead issues in non-Medtronic leads at a...
Medtronic's current internal analysis and testing shows iPad technology presents no risk of electromagnetic interference with Medtronic implantable cardiac rhythm devices when used per manufacturer's instructions. However, as a precaution, patients implanted with a pacemaker or ICD are advised to follow Apple and Medtronic labeling recommendations and maintain a distance of six inches between the iPad and implanted device.
Gain best practices in overcoming international labeling challenges at the Medical Device Global Labeling Strategies Conference, July 24-25, 2013 in Minneapolis, MN. This premier marcus evans event will bring together leading medical device labeling professionals to discuss how to successfully create a label on both a national and international scale.