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Michael Berman Joins InspireMD Board

February 11, 2013 8:01 am | by The Associated Press | News | Comments

InspireMD, Inc. ("InspireMD" or the "Company") (OTC: NSPRD) announced that Michael Berman joined its board of directors. Mr. Berman previously served as a Senior Vice President of Boston Scientific Corp., Group President of its cardiology businesses, and a member of the Executive Committee. ...

Zoll Lands FDA Clearance for Automated External Defibrillator

February 8, 2013 3:27 pm | by Mass Device | News | Comments

Zoll Medical wins 510(k) clearance for its AED Plus CPR-assist technology. Asahi Kasei (TYO:3407) subsidiary Zoll Medical won 510(k) clearance from the FDA for its fully-automated AED Plus device, which improves on the former semi-automatic model. The new automated external defibrillator allows emergency responders to pre-program a shock instead of pushing the "shock" button.

Supreme Court Denies Retractable Technologies in Patent War with BD

February 8, 2013 3:08 pm | by Mass Device | News | Comments

The Supremes last month refused to hear an appeal of a lower court's decision to overturn part of Retractable's win over BD, which the Little Elm, Texas-based medical device company sued in June 2007, claiming that Becton's Integra syringes infringe patents covering its competing VanishPoint devices.

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Data from St. Jude Medical RESPECT Trial for PFO Closure Highlighted at International Stroke Conference 2013

February 8, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Feb 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association’s International Stroke Conference 2013 in Honolulu. The RESPECT...

Two-Year Clinical Study Supports Safety and Efficacy of Covidien Solitaire™ FR Revascularization Device

February 7, 2013 6:42 pm | by The Associated Press | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the Solitaire™ FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR...

Two-Year Clinical Study Supports Safety and Efficacy of Covidien Revascularization Device

February 7, 2013 6:42 pm | by The Associated Press | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the Solitaire™ FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR...

Researchers Find a Genetic Marker for Aortic Valve Disease

February 7, 2013 2:13 pm | by Mass Device | News | Comments

A research consortium tracks down a genetic variant that doubles the risk of buildup in the aortic valve that can cause heart failure, stroke and sudden cardiac death. A team of researchers have pinpointed a gene that may be responsible for double a patient's risk of calcium buildup in the aortic valve, a condition linked with heart failure, stroke and sudden cardiac death. The finding may lead to new research and therapies, which are very limited for patients with narrowing, or stenosis, of the aortic valve.

Fully Automatic AED Plus from ZOLL Granted 510(k) Clearance by U.S. Food and Drug Administration

February 7, 2013 1:22 pm | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin U.S. distribution of the new fully...

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Sorin Group Announces Preliminary Results for 2012

February 7, 2013 12:06 pm | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Feb 7, 2013--At a meeting held today and chaired by Rosario Bifulco, the Sorin S.p.A. (MIL:SRN) Board of Directors analyzed the results for the fourth quarter 2012 and the preliminary unaudited consolidated results for the year of 2012. The final draft of the financial...

Biosensors Collaborates with Terumo to Promote NoboriT in Japan

February 7, 2013 10:05 am | by The Associated Press | News | Comments

Biosensors International Group, Ltd., a developer, manufacturer and marketer of innovative medical devices, has announced a collaboration with Terumo Corporation to promote the NoboriT drug-eluting stent (DES) system at specific specialist cardiology centers in Japan.

Cardiva Medical, Inc. Announces FDA Approval for VASCADE Vascular Closure System

February 7, 2013 9:40 am | by PRNewswire | News | Comments

Cardiva Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the VASCADE Vascular Closure System (VCS). Clinical data from a prospective, multi-center, randomized 420 patient trial demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression...

Abiomed CEO Shrugs off Impact of DoJ Probe, FDA Call

February 6, 2013 4:41 pm | by Mass Device | News | Comments

A U.S. Justice Dept. investigation and the FDA's decision to require pre-market approval for Abiomed's Impella heart pump leave CEO Michael Minogue unfazed. Cardiologists aren't paying much attention to the noise around Abiomed (NSDQ:ABMD) and its flagship medical device, the Impella heart pump, at least according to chairman, president & CEO Michael Minogue.

European patient registry in venous thromboembolism (VTE) enrols first patient

February 6, 2013 11:29 am | by PR Newswire | News | Comments

MUNICH, February 6, 2013 /PRNewswire/ -- The registry plans to gather data from more than 4,000 patients with VTE across seven European countries, providing insights into the clinical management of a disease that is a leading cause of morbidity and mortality[1] Daiichi Sankyo...

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Merit Medical Partners With Verite Mobile Tools and Strategies to Create an Innovative Medical Device Conversion App

February 6, 2013 9:00 am | by The Associated Press | Merit Medical Systems, Inc. | News | Comments

Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, and Vérité, a digital communications agency, announced the release of a cutting-edge iPhone App, Merit Convert, available on...

TherOx Begins IDE Study of Next-Generation Supersaturated Oxygen Therapy for AMI

February 6, 2013 8:00 am | by The Associated Press | News | Comments

IRVINE, Calif.--(BUSINESS WIRE)--Feb 6, 2013--TherOx, Inc., a privately held medical device company focused on the treatment of Acute Myocardial Infarction (AMI), today announced the initiation of its multicenter Investigational Device Exemption (IDE) pilot study of a second generation system that...

Vasomedical, Inc. to Present Live Webcast at RetailInvestorConferences.com on February 7th

February 6, 2013 8:00 am | by PR Newswire | News | Comments

NEW YORK, Feb. 6, 2013 /PRNewswire/ -- Vasomedical, Inc. ("Vasomedical") (OTC BB: VASO), a diversified medical technology company specializing in the design, manufacture and sale of medical devices for noninvasive cardiology including EECP® systems, the gold standard of ECP...

Abiomed Announces Revenue of $38.3 Million, Up 19% and Record Impella Patient Usage, Up 26%

February 6, 2013 3:44 am | by GlobeNewswire | News | Comments

Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2013 revenue of $38.3 million, up 19% compared to revenue of $32.2 million in the same period of fiscal 2012, on record quarterly patient usage, up 26% compared to the same period of fiscal 2012.

ZOLL Receives Shonin Approval from Japan to Market Intravascular Temperature Management Technology

February 6, 2013 12:05 am | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 6, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to enter the Japanese market with its Intravascular Temperature...

Thoratec Reports Fourth Quarter And Full Year Fiscal 2012 Financial Results

February 5, 2013 4:02 pm | by PR Newswire | News | Comments

PLEASANTON, Calif., Feb. 5, 2013 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today reported its financial results for the fourth quarter of 2012. "Thoratec...

Cook Medical Study of Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions Exceeds 50% Enrollment

February 5, 2013 9:03 am | by The Associated Press | News | Comments

BLOOMINGTON, Ind.--(BUSINESS WIRE)--Feb 5, 2013--With more than 100 patients enrolled, Cook Medical has exceeded 50 percent enrollment in the Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions trial. The first-of-its-kind, prospective, multicenter study is evaluating the retrograde...

MGC Diagnostics Corporation Announces National Jewish Health Selects the Company as Preferred Provider for Cardiopulmonary Diagnostic Instrumentation

February 5, 2013 8:00 am | by PR Newswire | News | Comments

SAINT PAUL, Minn., Feb. 5, 2013 /PRNewswire/ -- MGC Diagnostics Corporation (NASDAQ: MGCD) (formerly Angeion Corporation), a global medical technology company, today announced that National Jewish Health has selected MGC Diagnostics as its preferred provider of cardiopulmonary...

Pacemaker Payment Plans, Courtesy of Medtronic

February 5, 2013 7:29 am | by Mass Device | News | Comments

Medtronic offers patients in India the option to pay off a pricey cardiac implants in installments. Medtronic's (NYSE:MDT) India division is offering patients an "easy monthly installment" plan to help families cope with the high cost of cardiac implants. The EMI program is available in 60 hospitals in 18 cities and applies to a handful of medical devices...

Edwards Lifesciences Reports Strong Fourth Quarter Results

February 4, 2013 4:03 pm | by The Associated Press | News | Comments

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended December 31, 2012, of $91.1 million, or $0.77 per diluted share, compared to net income of $63.1 million, or $0.53 per...

Medtronic Announces CE Mark of Evera® Portfolio of Implantable Cardioverter-Defibrillators

February 4, 2013 8:06 am | by The Associated Press | News | Comments

Medtronic today announced CE Mark of the Evera portfolio of implantable cardioverter-defibrillators. With increased longevity and the most advanced shock reduction technology available, the new family of ICDs is the first to feature the PhysioCurve design, a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30%.

St. Jude Announces First Implant Evaluating New Size of Portico Heart Valve in European Trial

February 4, 2013 8:00 am | by The Associated Press | News | Comments

St. Jude Medical, Inc. announced the first patient implant of its 25 mm Portico Transcatheter Aortic Heart Valve using the Transfemoral Delivery System in its ongoing European trial. The Portico valve system offers a minimally invasive treatment option for patients with severe aortic stenosis – a narrowing of the aortic valve that obstructs blood flow from the heart.

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