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Medical Device Technology
St Jude Medical receives European CE Mark approval for intracardiac echocardiography catheter
Catheters : 18 January, 2013
St Jude Medical receives European CE Mark approval of the company's ViewFlex Xtra Intracardiac Echocardiography (ICE) Catheter.
 
Covidien launches therapeutic device for treatment of resistant hypertension
Balloons : 17 January, 2013
Covidien is launching the OneShot Renal Denervation System, an over the wire balloon-based irrigated catheter technology for the treatment of high blood pressure or hypertension.
 
Open-irrigated temperature ablation catheter clinical trial sees first patient treated
Catheters : 17 January, 2013
The first patient has been treated in the Boston Scientific ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer Open-Irrigated Temperature Ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation.
 
Covidien starts patient enrollment for acute ischemic stroke study
Endovascular medical devices : 15 January, 2013
Covidien is launching a new study, SWIFT PRIME, which enrolled its first patient at the University at Buffalo.
 
Covidien acquires CV Ingenuity
Balloons : 14 January, 2013
Covidien completes the acquisition of CV Ingenuity.
 
Randomized multicentre clinical trial aims to study minimally invasive device to treat heart failure
Catheters : 10 January, 2013
CardioKinetix, a medical device company pioneering a catheter-based treatment for heart failure, is reporting that the first patients are beginning enrollment in PARACHUTE IV, the randomized pivotal US trial of the minimally invasive Parachute Ventricular Partitioning Device for the treatment of heart failure.
 
Covidien plans to acquire CV Ingenuity
Balloons : 27 December, 2012
Covidien declares a definitive agreement to acquire CV Ingenuity with the companies expecting to complete the acquisition in the first calendar quarter of 2013.
 
Avinger receives US FDA clearance for CTO crossing device with onboard imaging
Catheters : 20 December, 2012
Avinger, a medical device manufacturer of innovative, multi-functional imaging catheters for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD), receives US FDA clearance to market Ocelot | PIXL in the United States.
 
Covidien expands production of enteral feeding pumps and sets
Pumps and dispensers : 19 December, 2012
Covidien is expanding the capacity of the company's Kangaroo ePump and Kangaroo Joey enteral feeding pumps and sets.
 
St Jude Medical enrolls first patient in study to develop guidance for stent optimization
Cardiac devices and equipment : 19 December, 2012
St Jude Medical is reporting the first patient enrollment in the company's ILUMIEN I clinical study.
 
Revascularization device receives regulatory approval in Canada
Cardiac devices and equipment : 14 December, 2012
Covidien's Solitaire FR Revascularization Device, is used to restore blood flow to the brain in patients suffering from acute ischemic stroke, is approved by Health Canada.
 
US FDA panel reclassifies intra-aortic balloon pumps to A Class II designation in certain indications
Balloons : 14 December, 2012
MAQUET Cardiovascular, the leader in intra-aortic balloon (IAB) therapy, reveals that the Circulatory System Devices Panel of the US Food and Drug Administration (FDA) recently voted to support the Agency's reclassification of intra-aortic balloon pump (IABP) devices for certain indications to Class II (general controls and special controls) from Class III (general controls and pre-market approval).
 
GE Healthcare and Covidien collaborate to enhance infant safety and care in NICU
Pulse oximeters : 13 December, 2012
Covidien is integrating the company's industry-leading Nellcor pulse oximetry with OxiMax technology into GE Healthcare Giraffe and Panda infant warmers.
 
ZOLL releases the first paediatric electrodes that report CPR quality
Cardiac devices and equipment : 13 December, 2012
ZOLL Medical is claiming that the company's new FDA-cleared OneStep Pediatric CPR Electrodes are the only electrodes on the market with a built-in sensor that reports CPR quality on young children up to eight years of age.
 
Combined triple lumen/IVC filter receives CE Mark
Catheters : 11 December, 2012
BiO2 Medical receives CE Mark approval for the triple lumen Angel Catheter which is a Nitinol, Inferior Vena Cava (IVC) filter, permanently attached to a central venous catheter (CVC) for the use of preventing Pulmonary Embolism (PE) in critically ill patients.
 
FDA 515i panel recommends Class III status for Abiomed's temporary ventricular support devices
Cardiac devices and equipment : 10 December, 2012
The US Food and Drug Administration's (FDA) Circulatory System Devices Panel votes to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Abiomed's Impella.
 
Sorin Group achieves first PARADYM RF implant in North America
Cardiac devices and equipment : 07 December, 2012
Sorin Group reports the first implant of PARADYM RF in Canada at the Montreal Heart Institute.
 
Sorin Group receives Japanese PMDA approval of aortic pericardial heart valve
Cardiac devices and equipment : 06 December, 2012
Sorin Group receives the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for the company's Mitroflow Aortic Pericardial Heart Valve.
 
CareFusion and Cerner implements integrated solution to streamline IV medication management
Pumps and dispensers : 04 December, 2012
CareFusion is implementating a solution that connects the company's Alaris System smart infusion pumps with the Cerner Millennium electronic health record (EHR) at Children's Hospitals and Clinics of Minnesota.
 
IWK Health Centre standardises on Masimo SET pulse oximetry solution
Pulse oximeters : 29 November, 2012
The IWK Heath Centre, Atlantic Canada's leading health centre providing specialised, quality care to women, children, youth and families, has converted to Masimo SET pulse oximetry and sensor technologies, the standard-of-care at leading health organizations worldwide.
 
St Jude Medical receives CE Mark approval of implantable ICDs and CRT-Ds
Cardiac devices and equipment : 29 November, 2012
St Jude Medical receives European CE Mark approval of the Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
 
Boston Scientific defibrillators receive CE Mark for extended longevity
Cardiac devices and equipment : 22 November, 2012
Boston Scientific receives CE Mark approval for increased longevity projections for the INCEPTA, ENERGEN, PUNCTUA, COGNIS and TELIGEN implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
 
Sparton acquires Onyx
Cardiac devices and equipment : 22 November, 2012
Sparton, a premier supplier of electromechanical devices, sub-assemblies and related services for highly regulated environments in the Medical, military, aerospace and industrial markets announces that its wholly owned subsidiary, Sparton Onyx completed its acquisition of Onyx EMS on November 15, 2012 in a $43.25 million all-cash transaction, subject to certain post-closing adjustments.
 
NDS Surgical Imaging releases new surgical display solutions
Displays and monitors : 12 November, 2012
NDS Surgical Imaging (NDSsi) is expanding the company's family of advanced LED backlight surgical displays with the release of the new 24-inch Radiance G2, 55-inch Radiance G2 and 24-inch EndoVue monitors.
 
Improved device programming reduces inappropriate therapy for implantable defibrillator patients
Cardiac devices and equipment : 08 November, 2012
Boston Scientific and the University of Rochester Medical Center are presenting positive results from the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) clinical trial that demonstrated improved programming of the Boston Scientific dual-chamber implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) heart devices can reduce inappropriate therapy and risk of death.
 
Skagit Valley Hospital standardises on Masimo SET pulse oximetry solutioni
Pulse oximeters : 08 November, 2012
Skagit Valley Hospital is standardising the hospital system-wide to Masimo's SET Pulse Oximetry.
 
Study shows that renal denervation technology is safe and sustained at six months
Catheters : 06 November, 2012
New data released in the Clinical Science and Special Reports Session during the annual American Heart Association (AHA) meeting indicates that St Jude Medical's EnligHTN renal denervation system provides a safe, effective and sustained reduction in office and ambulatory blood pressure measurements at six months.
 
Ege University Hospital in Turkey discharges first SynCardia Total Artificial Heart patient
Cardiac devices and equipment : 02 November, 2012
For the first time in Izmir, Turkey, a patient implanted with the SynCardia temporary Total Artificial Heart is discharged from the hospital.
 
Kennedy Health System renews system-wide pulse oximetry deal with Masimo
Pulse oximeters : 02 November, 2012
Kennedy Health System, which encompasses three acute care New Jersey hospitals on the cutting edge of new technology and medical procedures, is renewing the health system's long-standing contract and commitment to Masimo SET as its pulse oximetry standard-of-care.
 
New safety IV catheter receives CE clearance
Catheters : 31 October, 2012
Smiths Medical's Jelco IntuitIV Safety IV Catheter for intravenous infusion receives the CE mark for clinical use in the European Economic Area (EEA) and other countries accepting CE-marked devices.
 
Molex adds next generation medical devices to the MediSpec portfolio
Connectors : 31 October, 2012
Molex Incorporated is expanding the company's suite of MediSpec interconnect technologies and reinforcing its commitment to innovative medical electronics with the recent acquisition of Affinity Medical Technologies.
 
Trial shows FFR-guided PCI is cost effective and improves patient outcomes
Guidewires : 26 October, 2012
Data from the FAME II Trial shows that St Jude Medical's Fractional Flow Reserve (FFR)-guided treatment using PressureWire was cost effective for coronary interventions when compared to the best available medical therapy.
 
CardioKinetix receives CE Mark approval for full range of sizes for percutaneous treatment device
Cardiac devices and equipment : 25 October, 2012
CardioKinetix receives CE Mark approval for the full size matrix of its Parachute Ventricular Partitioning Device for Percutaneous Ventricular Restoration (PVR) therapy.
 
Transcatheter aortic valve system virtually eliminates aortic regurgitation with no vascular complications
Catheters : 25 October, 2012
Transcatheter heart valve innovator Direct Flow Medical's DISCOVER CE Mark trial met its primary mortality endpoint.
 
San Raffaele Hospital discharges first SynCardia Total Artificial Heart patient home
Cardiac devices and equipment : 22 October, 2012
San Raffaele Hospital in Milan, Italy, discharges the hospital's first patient to receive the SynCardia temporary Total Artificial Heart.
 
Medtronic launches Japan's first MR-conditional pacemaker system
Pacemakers : 22 October, 2012
Medtronic receives Japanese regulatory approval and plans to launch the Advisa DR MRI SureScan pacing system which is the first and only MR-Conditional pacemaker available to patients in Japan, the world's second largest market for medical devices.
 
OncoSec receives CE Mark for new electroporation device
Electroporation equipment : 19 October, 2012
OncoSec Medical receives authorization to CE mark the company's proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, for use in the European Economic Area (EEA).
 
First-in-Human study starts for valvuloplasty scoring balloon for critical aortic valve stenosis
Balloons : 18 October, 2012
AngioScore successfully initiates enrollment in the 'CardioSculpt' Valvuloplasty Scoring Balloon for Critical Aortic Valve Stenosis First-in-Human (FIH) Study.
 
Vention Medical launches online store for heat shrink tubing, multi-layer tubing, and balloons
Balloons : 18 October, 2012
Vention Medical launches a new online store to respond to the need for faster, more timely delivery of its medical grade heat shrink tubing, multi-layer tubing, and medical balloons for medical device manufacturers.
 
Masimo initiates release of new pulse oximetry sensor system
Pulse oximeters : 17 October, 2012
Masimo is making a limited market release of the Universal ReSposable Pulse Oximetry Sensor System, offering the Measure-Through Motion and Low Perfusion performance and accuracy of SET, as well as the comfort of its single-patient-use adhesive sensors with the cost-effectiveness and environmental advantages of a reusable sensor.
 
New needlefree connector improves the management of neonatal and paediatric patient fluids
Connectors : 17 October, 2012
ICU Medical is introduceing the NanoClave low-profile neutral displacement needlefree connector, designed to keep neonatal and pediatric patients safe by minimizing flush volumes while providing a safe and effective microbial barrier.
 
ZOLL licensing deal aims to help users improve CPR quality with real time feedback
Cardiac devices and equipment : 17 October, 2012
GS Elektromedizinische Geraete G Stemple, who markets defibrillators under the corpuls brand, signs a licensing agreement with ZOLL Medical which allows corpuls to incorporate ZOLL's Real CPR Help feedback technology into corpuls devices to help their customers improve CPR quality.
 
Masimo unveils fractional arterial oxygen saturation sensor
Sensors : 16 October, 2012
Masimo receives the CE Mark and is unveiling the new fractional arterial oxygen saturation, SpfO2, parameter through the rainbow Universal ReSposable SuperSensor, the first noninvasive sensor to provide simultaneous monitoring of SpHb, SpCO, SpMet, SpfO2, SpOC, Perfusion Index, PVI, and Measure-Through Motion and Low Perfusion SpO2 and pulse rate.
 
Clinical study evaluates new imaging catheter to cross CTOs in patients with PAD
Catheters : 15 October, 2012
Avinger reveals results from the CONNECT II global clinical trial results at the Vascular Interventional Advances (VIVA) Conference 2012 in Las Vegas, Nevada.
 
Study confirms effectiveness of directional atherectomy as a therapy to treat PAD
Cardiac devices and equipment : 12 October, 2012
Covidien reveals final 12-month results from the company's DEFINITIVE LE (Determination of Effectiveness of SilverHawk/TurboHawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities) study.
 
Surefire Medical receives FDA clearance for angiographic catheters
Catheters : 12 October, 2012
Surefire Medical receives 510(k) FDA clearance to market the company's range of Surefire Angiographic Catheters which will be launched in the USA later in 2012.
 
Terumo Medical receives FDA clearance for next-generation welder and data management system
Tubes and tubing : 11 October, 2012
The US Food and Drug Administration (FDA) clears Terumo Medical's TSCD II/Trucise Data Management System for use in the USA.
 
Boston Scientific launches guidewire for crossing resistant lesions in peripheral arteries
Guidewires : 11 October, 2012
Boston Scientific is launching the company's Victory guidewire in the USA and Europe.
 
Boston Scientific receives FDA approval of S-ICD system for patients at risk of SCA
Cardiac devices and equipment : 09 October, 2012
The US Food and Drug Administration grants Boston Scientific regulatory approval for the company's S-ICD System, the world's first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA).
 
First SynCardia Total Artificial Heart patient receives heart transplant in Slovenia
Cardiac devices and equipment : 09 October, 2012
The University Medical Center (UMC) Ljubljana transplants Slovenia's first patient to receive the SynCardia temporary Total Artificial Heart.
 
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