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.
ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 20, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced publication of results from its landmark RESPECT trial in The New England Journal of Medicine. The study results show that device closure using the AMPLATZER™ PFO...
Sorin Group Receives Conditional FDA Approval to Conduct RESPOND CRT Clinical Trial Using Innovative Heart Failure Management TechnologyMarch 20, 2013 10:00 am | by The Associated Press | News | Comments
MILAN--(BUSINESS WIRE)--Mar 20, 2013--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device...
Newly Published Data Indicates St. Jude Medical Trifecta Heart Valve Closely Resembles the Hemodynamic Performance of a Natural, Healthy Heart ValveMarch 19, 2013 4:15 pm | by The Associated Press | News | Comments
ST. PAUL, Minn.--(BUSINESS WIRE)--Mar 19, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced that its Trifecta ™ biological pericardial aortic valve has demonstrated positive results in a new study published online in The Journal of Thoracic and Cardiovascular...
Massachusetts-based medical device startup DC Devices closed a $10.7 million funding round in support of its minimally invasive treatment for heart failure. DC Devices "seeks to become the leading medical device company for the treatment of congestive heart failure," according to its page on the website of venture capital firm General Catalyst.
Douglas Harrington, MD Addresses Select Group of Physicians Regarding Latest Advances in Cardiovascular Risk AssessmentMarch 19, 2013 2:44 pm | by The Associated Press | News | Comments
SAN FRANCISCO--(BUSINESS WIRE)--Mar 19, 2013--Aviir Inc., a biotechnology company dedicated to enhanced detection and prevention of cardiovascular disease through innovative diagnostic tests, announced that Douglas Harrington, MD, Clinical Professor of Pathology at USC and Aviir, Inc. CEO,...
Medical device start-up Topera Medical closed a $25 million funding round, according to federal Securities & Exchange Commission filings. The San Diego, Calif.-based startup, which came out of stealth mode at the Heart Rhythm Society meeting last year, has FDA 510(k) clearance for its RhythmView 3D mapping system.
SynCardia Systems won 2 new Humanitarian Use Device designations for its 50cc Total Artificial Heart as a cardiac bridge transplant device. The new HUD designations apply to use with children, smaller women and other people with small stature.
A review of the actionable news that came out of last week's American College of Cardiology conference in San Francisco, including mixed feelings about Boston Scientific's Watchman stroke prevention device and incremental findings for renal denervation.