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Medical Device Technology
St Jude Medical receives FDA clearance of the AMPLATZER Vascular Plug 4
Catheters : 19 June, 2012
St Jude Medical receives US Food and Drug Administration (FDA) clearance and plans to immediately launch the AMPLATZER Vascular Plug 4 (AVP 4) for use in transcatheter embolization procedures (minimally invasive procedures that involve the selective blocking of blood vessels) within the peripheral vasculature.
 
Heart pump provides percutaneous haemodynamic support
Cardiac devices and equipment : 18 June, 2012
Abiomed receives Health Canada approval to market the Impella cVAD device, a new percutaneous Impella heart pump that provides peak flow of approximately four litres of blood per minute.
 
Endosense completes enrollment in force-sensing ablation catheter study
Catheters : 15 June, 2012
TOCCASTAR is a prospective, randomized, multi-centre investigational device exemption (IDE) trial designed to evaluate the safety and effectiveness of the company's TactiCath force-sensing ablation catheter in patients with symptomatic paroxysmal atrial fibrillation (AF).
 
Barco clinical displays support Chinese e-hospital project
Displays and monitors : 15 June, 2012
Barco wins an exclusive contract to provide MDRC-2120 Clinical Review Displays for an e-hospital project that includes over 60 sites in Gansu Province, China.
 
Endosense receives CE Mark approval for force-sensing ablation catheter
Catheters : 13 June, 2012
Endosense's TactiCath Quartz force-sensing ablation catheter is now CE mark approved.
 
NHS favours Intra Operative Fluid Management solutions
Pulse oximeters : 11 June, 2012
The National Health Service Technology Adoption Centre in the United Kingdom is advising hospitals to use Intraoperative Fluid Management Technologies as a way to improve patient outcomes, and includes Masimo PVI, the only noninvasive and continuous method to help clinicians manage fluid during surgeries.
 
Covidien launches bedside SpO2 patient monitoring system
Pulse oximeters : 08 June, 2012
Covidien is launching the Covidien Nellcor Bedside SpO2 Patient Monitoring System at the European Society of Anesthesiology Congress, held in Paris June 9-12, 2012.
 
Philips wireless portable detector maximises DR flexibility and efficiency
Wireless equipment : 04 June, 2012
Philips Healthcare is introducing wireless portable detector (WPD) sharing functionality on the company's static and mobile digital radiography (DR) and digital radiography/fluoroscopy (DRF) equipment.
 
MAQUET Cardiovascular acquires dual lumen catheter from Avalon Laboratories
Catheters : 31 May, 2012
MAQUET Cardiopulmonary, a business unit of MAQUET Cardiovascular, signs an agreement with Avalon Laboratories to acquire its Avalon Elite Bi-Caval Dual Lumen Catheter and complimentary vascular access kits for use during ECMO and ECLS.
 
Stryker reveals positive clinical results from the Trevo Retriever system
Endovascular medical devices : 28 May, 2012
Stryker reveals the results of the TREVO 2 clinical trial which sees the study meeting the primary effectiveness endpoint, with the Trevo Retriever achieving significantly better post-device revascularization than the Merci Retriever (86.4 percent in the Trevo Retriever arm compared to 60 percent in the Merci Retriever arm).
 
GE Healthcare and Philips commend FCC wireless medical sensor ruling
Wireless equipment : 28 May, 2012
GE Healthcare and Philips Electronics are applauding the USA's Federal Communications Commission (FCC)for its action allocating protected spectrum for wireless medical devices, called Medical Body Area Networks (MBANs), which could revolutionize the way patients are monitored and help eliminate the restrictive cables that tether patients to hospital beds.
 
TriReme Medical receives FDA approval for torqueable PTCA balloon catheter
Catheters : 25 May, 2012
TriReme Medical receives approval by the US Food and Drug Administration (FDA) of the Glider PTCA Catheter, indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion.
 
Barco's healthcare displays support NFL scouting medical evaluations
Displays and monitors : 25 May, 2012
Barco is partnering for a second year with Indiana University Health to supply the company's top-of-the-line diagnostic and clinical displays for the 2012 NFL Scouting Combine.
 
Cook expands range of endoscopic ultrasound needles with small gauge addition
Needles : 23 May, 2012
Cook Medical is adding a 25 gauge needle to its EchoTip ProCore line of fine needle biopsy (FNB) histology needles, which are designed for use in a procedure known as endoscopic ultrasound, or EUS.
 
Nonin receives FDA 510(k) for expanded labelling of fingertip pulse oximeter
Pulse oximeters : 23 May, 2012
Nonin Medical is releasing the company's Onyx Vantage 9590 professional fingertip pulse oximeter with expanded labelling claims.
 
Catheter-based parachute ventricular partitioning device reveals new clinical data
Cardiac devices and equipment : 22 May, 2012
CardioKinetix is reporting two-year clinical results for the first-of-its-kind catheter-based Parachute Ventricular Partitioning Device, a Percutaneous Ventricular Restoration (PVR) therapy for patients with ischemic heart failure.
 
Peripheral vascular Paclitaxel releasing balloon reports positive efficacy results
Balloons : 22 May, 2012
Six-month results from the BIOLUX P-I study for the Biotronik Passeo-18 Lux Paclitaxel Releasing Balloon, demonstrating excellent safety and efficacy results according to a paper presented at the EuroPCR 2012 congress by Dr Andrej Schmidt, Chief Angiologist at Herzzentrum/Park- Krankenhaus, Leipzig, Germany.
 
Covidien releases new ablation catheter for treatment of Barrett's Oesophagus
Catheters : 21 May, 2012
Covidien launches the HALO90 ULTRA Ablation Catheter, the latest addition to the HALO family of catheters for the endoscopic treatment of Barrett's oesophagus.
 
MAQUET receives 510(k) clearance for new intra-aortic balloon catheter sizes
Catheters : 17 May, 2012
MAQUET Cardiovascular receives 510(k) clearance from the US Food and Drug Administration (FDA) for its new MEGA 7.5Fr 30cc and 40cc intra-aortic balloon (IAB) catheters.
 
Covidien acquires superDimension
Minimally invasive medical devices : 17 May, 2012
Covidien completes the acquisition of superDimension, for an aggregate consideration of approximately $300 million, with future earn out payments possible.
 
Boston Scientific offers ICD and CRT-D Device warranties of up to 10 years
Cardiac devices and equipment : 15 May, 2012
Boston Scientific is introducing extended warranties of up to 10 years, depending on the model, for its ENERGEN and INCEPTA implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
 
Study shows cost-effectiveness benefits of CRT-D therapy
Cardiac devices and equipment : 15 May, 2012
Medtronic reveals findings from an economic analysis of the landmark RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) trial demonstrating that cardiac resynchronization therapy with defibrillation (CRT-D) is a cost-effective treatment for mildly symptomatic heart failure patients.
 
Biotronik launches new external pacemaker in the USA
Pacemakers : 15 May, 2012
Biotronik is launching in the USA the company's new Reocor external pacemaker.
 
St Jude Medical reveals results of SCD-HeFT 10-Year follow-up study
Cardiac devices and equipment : 14 May, 2012
St Jude Medical announces results of the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) 10-Year Follow-up Study at Heart Rhythm 2012, the Heart Rhythm Society's 33rd Annual Scientific Sessions in Boston, Massachusetts, USA.
 
LAAC device shows reduction in stroke risk benefits
Cardiac devices and equipment : 14 May, 2012
Boston Scientific is reporting results from the ASA Plavix (ASAP) Study, which studied the WATCHMAN Left Atrial Appendage Closure (LAAC) device.
 
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).
 
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