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Medical Device Technology
St Jude Medical gains FDA approval of smaller ICD
Cardiac devices and equipment : 11 May, 2012
St Jude Medical receives US Food and Drug Administration (FDA) approval of its Ellipse implantable cardioverter defibrillator (ICD).
 
ICDs that reduce inappropriate shocks receive FDA approval
Cardiac devices and equipment : 10 May, 2012
St Jude Medical receives US Food and Drug Administration (FDA) approval of its Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
 
Boston Scientific reports first US implant of devices to treat bradycardia
Pacemakers : 09 May, 2012
Boston Scientific receives US Food and Drug Administration (FDA) approval and is launching the company's INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).
 
Medical Vision launches new arthroscopy pump with RF compatibility
Pumps and dispensers : 08 May, 2012
Medical Vision is launching of the company's new technology Double Pump RF, an arthroscopy pump that adjusts flow and pressure automatically when a shaver or an RF system is in use.
 
Hansen Medical unveils new robotic catheter system
Catheters : 08 May, 2012
Hansen Medical plans to showcase the Sensei X Robotic Catheter System at the Heart Rhythm Society's 33rd Annual Scientific Sessions from May 9-12, 2012 in Boston, Massachusetts, USA.
 
Angioslide receives FDA 510(K) clearance for new below the knee device
Balloons : 07 May, 2012
Angioslide receives FDA 510(K) clearance for the company's new 3 X 100mm PROTEUS device for treating Peripheral Artery Disease in below the knee (BTK) vasculature.
 
Masimo signs dual-source pulse oximetry deal with Novation
Pulse oximeters : 07 May, 2012
Masimo signs a three-year, dual-source agreement with Novation, the healthcare contracting services company of VHA and the University Health System Consortium (UHC).
 
Nonin Medical awarded Novation contract for pulse oximeters
Pulse oximeters : 07 May, 2012
Novation, the largest health care supply contracting company in the USA, awards a 36-month contract to Nonin Medical for its pulse oximeters and sensors.
 
Trial shows renal denervation system shows blood pressure reduction benefits
Cardiac devices and equipment : 30 April, 2012
Medtronic is reporting six month pooled outcomes from randomized and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity renal denervation system showing significant, sustained blood pressure reduction in patients with treatment-resistant hypertension.
 
UKE installs Barco's clinical review displays for dental exams
Displays and monitors : 26 April, 2012
The Center for Dental and Oral Medicine at the University Medical Center Hamburg Eppendorf, Germany, installs Barco's MDRC-2124 clinical review displays to ensure they retain the outstanding image quality throughout the imaging chain - from modality to display.
 
Boston Scientific receives CE Mark for Emerge PTCA dilatation catheter
Catheters : 26 April, 2012
Boston Scientific receives CE Mark and plans the European market launch of the Emerge PTCA Dilatation Catheter.
 
CareFusion and Cerner integrate smart pump technologies to improve safety
Pumps and dispensers : 25 April, 2012
CareFusion and Cerner are announcing the live limited commercial release of a new infusion pump connectivity solution at Oklahoma Heart Hospital, one of the USA's first all-digital hospitals exclusively focused on heart care.
 
Omnetics releases panel mounted latching micro-D connectors
Connectors : 24 April, 2012
Omnetics Connector is launching the company's Latching Micro-D connectors with a new squeeze-latch system that offers significant advantages in making quick cable connections to rack and panel equipment.
 
Accent MRI pacemaker and Tendril MRI lead achieve first implant
Pacemakers : 20 April, 2012
St Jude Medical achieves the first implant of the company's Accent MRI Pacemaker and Tendril MRI Lead IDE Study (MRI Study).
 
Stryker's DVT device delivers fiscal benefits
Endovascular medical devices : 20 April, 2012
Stryker's Sustainability Solutions division is introducing Restep, the company's pioneering deep vein thrombosis (DVT) solution.
 
OmniGuide unveils next generation CO2 laser surgery system
Laser systems : 18 April, 2012
OmniGuide, a Cambridge, Massachusetts medical device company specializing in advanced energy surgical instruments, is launching the company's new FELS-25A Intelliguide, the next generation laser system for minimally invasive CO2 laser surgery.
 
Medtronic begins landmark US drug-eluting balloon study
Balloons : 17 April, 2012
Medtronic is starting the Medtronic IN.PACT SFA II study, the company's first US clinical trial for its line of IN.PACT drug-eluting balloons.
 
Smaller ICD with physician-Inspired shape receives CE Mark
Cardiac devices and equipment : 17 April, 2012
St Jude Medical receives CE Mark approval of the company's Ellipse implantable cardioverter defibrillator (ICD) which was designed with feedback from more than 200 physicians from around the world.
 
Excelitas unveils White COB LED package for medical applications
LED technology : 16 April, 2012
Excelitas Technologies introduces the company's newest model in the ACULED Family of Chip-On-Board LED packages, which has been designed to meet the rigorous performance requirements of medical applications such as surgical operating room lights, examination lights, and dental operatory lights.
 
Abiomed's Impella cVAD device receives CE Mark
Cardiac devices and equipment : 13 April, 2012
Abiomed receives CE Marking approval in the European Union to market the Impella cVAD device, a new percutaneous Impella heart pump that provides peak flow of approximately four litres of blood per minute.
 
Boston Scientific launches steerable sheath in the USA
Catheters : 13 April, 2012
Boston Scientific is launching the company's Z Flex-270 Steerable Sheath in the USA which is a device that is intended for use in a wide range of electrophysiology (EP) procedures to facilitate the introduction and placement of diagnostic and therapeutic catheters within the heart.
 
Ultra-compact image sensor enables Ambu's single-use intubation scope
Sensors : 13 April, 2012
OmniVision Technologies' OV6922 CMOS image sensor is being designed into Ambu's aScope 2, a single-use intubation scope intended for medical procedures such as difficult intubation and percutaneous dilatational tracheostomy (PDT).
 
Medtronic CRT-D receives FDA approval
Cardiac devices and equipment : 12 April, 2012
The US Food and Drug Administration (FDA) approves an expanded indication for Medtronic's cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices.
 
Boston Scientific launches new family of pacemakers in Europe
Pacemakers : 12 April, 2012
Boston Scientific receives CE Mark approval and European market launch of its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).
 
Biotronik REPLACE study sets new benchmarks for CIED replacement
Cardiac devices and equipment : 11 April, 2012
The Biotronik sponsored REPLACE study is the first prospective, multicentre trial to examine a broad range of complications related to replacement of all companies' cardiovascular implantable electronic devices (CIED) which includes both pacemakers and ICDs (implantable cardiac defibrillators).
 
Covidien prepares to acquire Oridion Systems
Pulse oximeters : 11 April, 2012
Covidien signs a definitive agreement to acquire Oridion Systems.
 
Abiomed reports first patient supported with Impella cVAD
Cardiac devices and equipment : 05 April, 2012
Abiomed is reporting the successful first human use of the Impella cVAD device, a new, percutaneous Impella heart pump that provides peak flow of approximately four litres of blood per minute.
 
Ablation catheter with MVG technique provides optimal clinical results
Catheters : 30 March, 2012
Biotronik's AlCath Gold ablation catheter, together with the maximum voltage-guided (MVG) technique for radiofrequency catheter ablation of atrial flutter, is shown to provide optimal clinical results following post-hoc analysis data from the AURUM 8 clinical study which was published in the Journal of Cardiovascular Electrophysiology (JCE) (Ref 1).
 
CTAF reveals bronchial thermoplasty assessement results
Catheters : 29 March, 2012
Boston Scientific announces the first published technology assessment in support of the safety, efficacy and long-term positive health outcomes of bronchial thermoplasty (BT) as delivered by the Alair Bronchial Thermoplasty System, a catheter-based device designed to treat patients 18 years or older with severe persistent asthma.
 
New study finds pacemakers reduce fainting in patients
Cardiac devices and equipment : 28 March, 2012
Medtronic reveals results of a double-blind, randomized study, ISSUE-3, which found that patients who suffered from fainting due to neurocardiogenic syncope had fewer fainting occurrences when treated with a Medtronic pacemaker.
 
St Jude Medical selects PHRI to analyse ICD leads registry data
Cardiac devices and equipment : 27 March, 2012
St Jude Medical appoints Population Health Research Institute (PHRI), an academic health science research institute, to analyse data from three combined registries on the Riata ST Optim and Durata implantable cardioverter defibrillator (ICD) leads.
 
New guidewire for FFR measurement improves handling performance
Guidewires : 26 March, 2012
St Jude Medical receives US Food and Drug Administration (FDA) clearance for multiple enhancements to its PressureWire Fractional Flow Reserve (FFR) measurement guidewire.
 
Cardiac Mapping software release improves workflow efficiencies in EP labs
Cardiac devices and equipment : 23 March, 2012
St Jude Medical is launching worldwide the company's EnSite Velocity System Version 3.0 software which is designed to help shorten procedure times for patients undergoing electrophysiology (EP) procedures guided by a cardiac mapping system and improve workflow efficiencies in the EP lab.
 
Covidien releases new respiration rate monitoring software
Sensors : 22 March, 2012
The US Food and Drug Administration (FDA) grants 510(k) clearance to Covidien to market the Covidien Nellcor Respiration Rate Version 1.0 software and the Adult Respiratory Sensor.
 
Blue Medical releases new drug eluting balloon
Balloons : 22 March, 2012
Blue Medical is launching globally the company's CE approved drug eluting balloon (DEB) Protege as well as its CoCr stent on DEB Pioneer.
 
Bridge-to-transplant clinical trial adds additional patients
Cardiac devices and equipment : 20 March, 2012
The US Food and Drug Administration (FDA) approves an IDE (Investigational Device Exemption) Supplement that allows HeartWare International to enroll a fourth allotment, of 54 additional patients, in its ADVANCE bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).
 
UPMC pathology study scores Barco Coronis Fusion display highly
Displays and monitors : 20 March, 2012
A scientific study conducted by the University of Pittsburgh Medical Center's (UPMC) pathology department ranks Barco's Coronis Fusion 6MP DL medical display as number one in image quality and diagnostic confidence, outscoring other display modalities in a side-by-side comparison that also included consumer displays and medical displays, when viewing whole slide images.
 
pSivida enters tech evaluation deal with Neuron Systems
Drug delivery equipment : 15 March, 2012
pSivida is entering into a technology evaluation agreement for its bioerodible Durasert drug delivery technology in ophthalmology with Neuron Systems, an ocular drug development company based in Burlington, Massachusetts, USA.
 
Philips enhances monitor/defibrillator for EMS
Cardiac devices and equipment : 13 March, 2012
Philips is introducing the tactically enhanced HeartStart MRx Monitor/Defibrillator for emergency medical services (EMS).
 
Boston Scientific to acquire Cameron Health
Cardiac devices and equipment : 12 March, 2012
Boston Scientific is exercising its option to acquire Cameron Health, a privately held company based in San Clemente, California, USA.
 
Stryker launches heavy duty surgical power tools
Power supplies and devices : 09 March, 2012
Stryker is releasing its System 7 - the next generation of heavy duty surgical power tools for use in total joint procedures, such as hip and knee replacements.
 
Pacemaker lead expands patient access to MRI technology
Cardiac devices and equipment : 09 March, 2012
Medtronic receives the CE Mark for the CapSure Sense MRI SureScan pacing leads, which are approved for use during Magnetic Resonance Imaging (MRI).
 
Covidien launches ablation catheter to treat Barrett's oesophagus
Catheters : 08 March, 2012
Covidien is launching the HALO60 Ablation Catheter, the latest addition to the HALO family of catheters for the endoscopic treatment of Barrett's oesophagus.
 
Excelitas Technologies acquires Carsan Engineering
Power supplies and devices : 08 March, 2012
Excelitas Technologies completes the acquisition of the business of privately-held Carsan Engineering, a Golden, Colorado-based engineering design company and world leader in the manufacture of arc lamp power supplies for the medical and dental markets.
 
Covidien revascularization device receives FDA clearance
Endovascular medical devices : 07 March, 2012
Covidien's Solitaire FR revascularization device receives clearance by the US Food and Drug Administration.
 
Artificial pancreas meets efficacy endpoints
Pumps and dispensers : 01 March, 2012
In the next step toward the development of an artificial pancreas, Medtronic, reports results of the in-clinic ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study have been published online and in the March edition of Diabetes Technology and Therapeutics.
 
Digital isolator technology supports new wireless comms devices
Electronic components : 29 February, 2012
Lantronix selects Analog Devices' iCoupler digital isolator technology to enable its new EDS-MD family of wireless communication network servers which features multiport medical device servers that represent the latest in healthcare communications by providing remotely controlled system-level management of multiple medical devices in a compact, secure and lightweight plastic enclosure.
 
Haselmeier creates new pen injector assembly facility in India
Drug delivery equipment : 29 February, 2012
Haselmeier, a leading designer and manufacturer of pen injection systems, plans to set up a new manufacturing facility in Bangalore, India to produce and supply high-quality, competitively priced pen injectors for the pharmaceutical industry in India.
 
Implantable defibrillator sees first implants in China
Cardiac devices and equipment : 27 February, 2012
Boston Scientific is reporting the first implants of a TELIGEN implantable cardioverter defibrillator (ICD) in China which were performed by Farong Shen, MD, in Zhejiang Hospital, Hangzhou and Wei Hua, MD, in Fuwai Hospital, Beijing, China.
 
Avinger enrolls first European PAD patient in CONNECT II trial
Catheters : 27 February, 2012
Avinger, a medical device manufacturer of innovative, multi-functional catheters for treating patients with Peripheral Artery Disease (PAD), is reporting the enrollment of the first European patient in the CONNECT II global clinical trial.
 
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