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Saudi Arabia Uses ZOLL's Temperature Management Solution to Revive Pilgrims from Heat Stroke During the Hajj Pilgrimage

January 16, 2012 5:34 am | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL® Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that the Saudi Arabia Ministry of Health purchased six ZOLL intravascular temperature management (IVTM™) systems...

Humedica Releases Cutting-Edge Predictive Model to Help Prevent Congestive Heart Failure Hospitalizations

January 16, 2012 5:15 am | News | Comments

BOSTON--(BUSINESS WIRE)--Humedica, the leading clinical analytics company, today announced the launch of a new predictive analytic model that will identify patients at high-risk for a Congestive Heart Failure (CHF) hospitalization. Designed to enable providers to identify high-risk CHF patients...

Data from St. Jude Medical's ASSERT Implantable Device Monitoring Study Published in New England Journal of Medicine

January 13, 2012 5:26 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, a global medical device company, today announced the publication of results from the ASSERT cohort study in the New England Journal of Medicine (NEJM). The ASSERT study, or ASymptomatic AF and Stroke Evaluation...

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Endosense Launches TactiCath 75 Force-Sensing Catheter, Announces New Results of EFFICAS I Clinical Study

January 13, 2012 5:14 am | News | Comments

GENEVA--(BUSINESS WIRE)--Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced the European launch of the TactiCath 75 force-sensing ablation catheter...

Biosense Webster Completes Enrollment in Ground-Breaking SMART-AF Trial

January 13, 2012 5:05 am | News | Comments

DIAMOND BAR, Calif.--(BUSINESS WIRE)--Biosense Webster Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the completion of enrollment in their latest ground-breaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study.

Biosense Webster Announces FDA approval of the THERMOCOOL SF Catheter in the United States

January 13, 2012 5:03 am | News | Comments

DIAMOND BAR, Calif.--(BUSINESS WIRE)--Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the FDA approval of the new THERMOCOOL® SF irrigated ablation catheter in the United States. The THERMOCOOL® SF NAV Catheter...

Intellicell Biosciences announces the licensing of its proprietary patent, pending stromal vascular fraction manufacturing technology

January 11, 2012 4:52 am | News | Comments

NEW YORK--(BUSINESS WIRE)--Intellicell Biosciences, Inc., (“Intellicell”) or the (“Company”), has licensed its proprietary, patent, pending technology for the manufacture of stromal vascular fraction from adipose tissue to Cell-Innovations, Pty Limited a company headquartered...

Cameron Health Submits PMA Application to FDA for the S-ICD System

January 10, 2012 6:33 am | News | Comments

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Cameron Health, Inc. (“Cameron Health”) announced today that it has submitted the Premarket Approval (PMA) application to the Food and Drug Administration (FDA) for the S-ICD System, the world's only completely subcutaneous implantable defibrillator.

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US Interventional Cardiology Device Market Will Shrink by Three Percent Per Year Through 2016

January 10, 2012 6:19 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, interventional cardiology devices in the United States will see a shrinking overall market due to a maturity in procedures and heavy downward pressures...

MedPlast's Pessary Balloon Manufacture Showcases Multi-Function Technical Mastery(2)

January 10, 2012 6:09 am | News | Comments

ELKHORN, Wis. -- MedPlast, Inc.'s ability to craft the pessary balloons that enhance quality of life for many women underscores the company's commitment to premium quality output and complete mastery of many separate - and complex - processes. Today's pessaries are precision-manufactured...

SANUWAVE Issued U.S. Patent for the Application of Acoustic Shock Waves Utilizing Its PACE Devices

January 9, 2012 5:48 am | News | Comments

ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the U.S. Patent and Trademark Office...

MindFrame Inc. Awarded New Patent for Breakthrough Capture LP Thrombectomy Technology

January 6, 2012 5:21 am | News | Comments

IRVINE, Calif.--(BUSINESS WIRE)--MindFrame Inc. today announces the issuance of U.S. Patent No. 8,088,140, bringing the total number of patents awarded for its breakthrough thrombectomy technology to three. The previous two patents, U.S. Patent Nos. 8,066,757 and 8,070,791...

New generation drug-eluting stents associated with lower rates of mortality and restenosis than bare metal stents

January 6, 2012 4:56 am | News | Comments

A registry -which includes every patient in Sweden having percutaneous coronary intervention (PCI) for the treatment of acute and stable coronary artery disease- has found that PCI implantations using a new generation of drug-eluting stents is associated with lower rates of relapse...

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An Outside Perspective: Joining Forces to Bring New Technology to Market

January 5, 2012 10:53 am | by John Havard | Articles | Comments

Medical device manufacturers that attempt to handle too many tasks in the product development process without the sufficient level of competency are simply setting themselves up for failure. It is vital for them to maintain a strong expertise in those core competencies and look outside for strategic partners who can aid them. This article examines that for the product design process.

CircuLite Awarded Grant from Cardiovascular Medical Research and Education Fund to Develop Right-Heart Circulatory Support System for Patients with Pulmonary Arterial Hypertension (PAH)

January 5, 2012 5:27 am | News | Comments

SADDLE BROOK, N.J.--(BUSINESS WIRE)--CircuLite®, Inc. today announced that it has received a grant from the Cardiovascular Medical Research and Education Fund, Inc. (CMREF) to fund the development of a right-heart circulatory support system based upon CircuLite's Synergy® Micro-pump...

Roche and Itamar-Medical Move Forward in Developing EndoPAT for Pre-Clinical Longitudinal Studies

January 5, 2012 5:15 am | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Itamar-Medical, the world's leader of non-invasive devices for diagnosis of cardiovascular health, announced achievement of the next milestone of the international pharmaceutical company, Roche, to further develop the EndoPAT technology for pre-clinical trials.

Implantable Pulse Generators ‘Stimulate’ Medical Device Industry

January 4, 2012 11:46 am | by Chris Vaillancourt | Articles | Comments

In recent years, there has been great excitement about the use of neuromodulation to treat a wide array of medical conditions and diseases. The technology uses electrical signals to stimulate or block different nerve impulses in the body and is adapted from technology used in cardiac rhythm management. Advanced ceramic materials are playing an important role in the technology and are poised to play an even greater one as these medical devices flood onto the market to treat an increasing number of ailments.

SeptRx reports first 20 patients have been enrolled in its “InterSEPT" CE Mark trial of the SeptRx Intrapocket PFO Occluder

January 4, 2012 5:44 am | News | Comments

FREMONT, Calif.--(BUSINESS WIRE)--SeptRx, an emerging medical device company that has developed the SeptRx® Intrapocket PFO Occluder (IPO) - a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO) - reported today that it has completed...

BioLineRx Announces Initiation of CE Mark Registration Trial for BCM (BL-1040), a Novel Medical Device for Prevention of Cardiac Remodeling Following Acute Myocardial Infarction

January 4, 2012 5:35 am | News | Comments

JERUSALEM--(BUSINESS WIRE)--BioLineRx, a biopharmaceutical development company, announced today the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling...

Presage® ST2 Assay Enters Routine Use for Heart Failure Patient Care

January 3, 2012 4:34 am | News | Comments

SAN DIEGO--(BUSINESS WIRE)--Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, announced today that a major European medical center, Hospital Germans Trias i Pujol in Barcelona Spain, is now using the company's Presage® ST2 Assay for routine care...

Bard Acquires Lutonix, Inc.

December 22, 2011 5:45 am | News | Comments

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. today announced that it has acquired Lutonix, Inc. for a purchase price of approximately $225 million paid at closing, with an additional $100 million to be paid upon PMA approval of Lutonix's drug-coated percutaneous transluminal angioplasty (PTA) balloon.

Tryton Announces DRG Reimbursement Code for Side Branch Stent in Germany

December 21, 2011 6:39 am | News | Comments

DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, announced that the German Institute for Medical Documentation and Information (DIMDI, Cologne) has revised the procedure code for the treatment of coronary bifurcations lesions...

CADD-Solis VIP Ambulatory Infusion System Launches in Additional European Markets

December 21, 2011 6:34 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Smiths Medical, a leading global medical device manufacturer, announced today it launched the CADD®-Solis VIP ambulatory infusion system with CADD™-Solis medication safety software in France, Germany, Switzerland and the Netherlands.

AtriCure's Synergy Ablation System Receives FDA Approval for the Treatment of Atrial Fibrillation

December 20, 2011 4:51 am | News | Comments

WEST CHESTER, Ohio--(BUSINESS WIRE)--AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, today announced that the U.S. Food and Drug Administration (FDA) has approved...

Berlin Heart's EXCOR Pediatric Ventricular Assist Device (VAD) Receives FDA Approval

December 20, 2011 4:46 am | News | Comments

THE WOODLANDS, Texas & BERLIN--(BUSINESS WIRE)--The Berlin Heart Group announced today that the FDA has granted “Humanitarian Device Exemption” (HDE) approval of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). The Berlin Heart EXCOR® Pediatric VAD...

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