C.R. Bard revealed a 1-2 punch today when it reported another loss in its patent infringement war with W.L. Gore and an adverse insurance decision that could cost it $25 million. The medical device company said in regulatory filings that the U.S. Patent & Trademark Office issued an initial finding in its reexamination of a Bard patent for a "Prosthetic vascular graft," known as the '135 patent.
Abiomed said the 1st patient to receive its right-side heart pump, the Impella RP, as part of a clinical trial aimed at U.S. approval was implanted with the device in Philadelphia. The Danvers, Mass.-based medical device company said the patient was implanted with the Impella RP after implantation with another type of heart pump called a left ventricular assist device.
SKANEATELES FALLS, N.Y.--(BUSINESS WIRE)--Apr 1, 2013--Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, today announced the launch of its new FlexiPort ® EcoCuff TM single-patient-use blood pressure cuff.
MORRISVILLE, N.C.--(BUSINESS WIRE)--Apr 1, 2013--SunTech Medical has updated its line of automated blood pressure monitoring with the Tango® M2 cardiac stress BP monitor. The new product provides accurate BP measurements during exercise and cardiac stress testing where noise and motion often make...
Thirteen-year-old Kyah DeSimone wanted to make cheerleading practice and good grades, not medical history. But after a frightening brush with heart failure, the eighth-grader became the first patient at Boston Children's Hospital to be implanted with a heart pump small and portable enough to restore her to normal life while she waits for a transplant.
WHEAT RIDGE, Colo.--(BUSINESS WIRE)--Mar 28, 2013--Positive clinical outcomes continue to be reported by researchers worldwide with transcatheter aortic valve implantation (TAVI). Moreover, new technologies are in development and will, in the future, offer additional minimally invasive treatment...
Varian Medical Systems Highlights Calypso® System and Other Technologies Designed to Help Reduce the Risk of Heart Disease after Radiotherapy for Breast CancerMarch 28, 2013 2:48 pm | by PR Newswire | News | Comments
PALO ALTO, Calif., March 28, 2013 /PRNewswire/ -- Varian Medical Systems (NYSE:VAR), the world leader in radiotherapy equipment and software, is highlighting its Calypso® System as a tool designed to help doctors reduce women's risk of developing heart disease years after...
Wall Street didn't move much on news of another insulation-related failure in St. Jude Medical's next-generation Durata defibrillator leads this week. The case report included a detailed analysis of an incident in which a Durata lead failed due to inside-out abrasion...
Biotronik said it's planning a mid-year launch in Europe for its Iforia MRI-safe pacemaker now that EU regulators have given the device CE Mark approval. The German medical device company said the Iforia is the world's 1st ICD/CRT-D device using the DF4 connector to be approved for magnetic resonance imaging, according to a press release.
The FDA slapped its most serious designation on the recall of hemostasis valves made by Vascular Solutions (NSDQ:VASC). The Minneapolis-based company last month recalled its Guardian II and Guardian II NC valves "due to a risk that air may be introduced into the device which may lead to an air embolism," according to the federal watchdog agency.
The FDA this month issued a new proposal on the regulatory oversight of automated external defibrillators, but at least 1 medical device maker is worried that enhanced oversight may harm public safety. Philadelphia-based CardioReady, maker of AED systems, urged that the FDA ensure that any new oversight not jeopardize the proliferation of AEDs, in the interest of public health.
Israel and Minnesota-based BioControl Medical won FDA approval to proceed with the 3rd and largest phase of its INOVATE-HF trail, evaluating its CardioFit vagal nerve stimulation system in treatment of heart failure. The global, multi-center trial aims to provide clinical data in support of BioControl's premarket approval application for FDA clearance of the CardioFit system.
In an engineering breakthrough, a Washington University in St. Louis biomedical researcher has discovered a way to use light and color to measure oxygen in individual red blood cells in real time.
U.S. Food and Drug Administration Approves Full Expansion of BioControl Medical’s INOVATE-HF Study of the CardioFit®March 26, 2013 7:00 am | by The Associated Press | News | Comments
YEHUD, Israel & NEW HOPE, Minn.--(BUSINESS WIRE)--Mar 26, 2013--BioControl Medical has received U.S. Food and Drug Administration approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption...
New Cardiac Electrical Biomarker Featured In Johns Hopkins Abstract Demonstrates Strong Correlation To High Sensitivity Troponin To Rule Out Acute Myocardial Ischemic InjuryMarch 25, 2013 12:20 pm | by The Associated Press | News | Comments
From the 2013 American College of Cardiology (ACC) Convention One of the leading complaints in the Emergency Department is chest pain and the timely detection of a heart attack is essential. Because of this, VectraCor, Inc., an emerging medical device company for cardiovascular solutions, is...
The Wyss Institute for Biologically Inspired Engineering at Harvard University announced that it was awarded a $9.25 million contract from the Defense Advanced Research Projects Agency (DARPA) to further advance a blood-cleansing technology developed at the Institute with prior DARPA support, and help accelerate its translation to humans as a new type of sepsis therapy.
Sensaris has announced that it has developed a novel, multi-sensor device for monitoring vital signs. Called the ZAO, it is currently going through the certification process and will be available mid 2013. Roughly the same size as a thick paperback book, it is designed to provide professional level diagnostic data so that it can be used by medical professionals and yet its low target volume price point of around €550 means that it can also be used by the home health market.
Have a heart problem? If it's fixable, there's a good chance it can be done without surgery, using tiny tools and devices that are pushed through tubes into blood vessels. Heart care is in the midst of a transformation. Many problems that once required sawing through the breastbone and opening up...
The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices. Defibrillators use electric shocks to jolt the heart back to normal after patients collapse from cardiac arrest.
Sorin Group (BIT:SRN) said the FDA granted conditional approval for an investigational device exemption for its SonR cardiac resynchronization device. The Italian medical device company said it will launch the Respond CRT trial to evaluate the SonR device in more than 1,000 U.S. patients with advanced heart failure.
Consumer Information on: Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) - P110013S005March 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
This is a brief overview of information related to FDA’s approval to market this product. See the links to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
A medical device industry analyst says Abbott Laboratories is unlikely to win approval anytime soon for its device used to repair heart valve problems, following a tepid endorsement by government experts. A Food and Drug Administration panel of heart experts voted 5-3 on Wednesday that the...
Intermountain Medical Center Uses SynCardia Total Artificial Heart to Bridge 31-Year-Old Father to a Heart TransplantMarch 21, 2013 11:24 am | by SynCardia Systems | News | Comments
SynCardia Systems announced today that Andrew Weaver, a 31-year-old husband and father of one who arrived at Intermountain Medical Center in Salt Lake City in grave condition, has been successfully bridged to a heart transplant with the SynCardia temporary Total Artificial Heart and discharged home.
FDA Advisory Committee Votes Favorably on Abbott's Minimally Invasive MitraClip® Device for Patients with Significant Mitral Regurgitation Who Are Too High Risk for SurgeryMarch 20, 2013 7:44 pm | by PR Newswire | News | Comments
ABBOTT PARK, Ill., March 20, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits of...
The FDA's Circulatory System Devices Panel voted today to make its recommendation regarding Abbott's (NYSE:ABT) premarket approval application for the MitraClip heart implant, agreeing unanimously that the device is safe but issuing a mixed result on the effectiveness and potential risks of the device.