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Medical Device Technology
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.
 
Volcano receives CE Mark and 510(k) clearance for digital IVUS catheter
Catheters : 09 October, 2012
Volcano receives clearance to market the company's new Visions PV .035 Digital IVUS Catheter in both the USA and Europe.
 
Creganna-Tactx Medical completes acquisition of ABT
Balloons : 08 October, 2012
Creganna-Tactx Medical acquires ABT Medical which is a company that designs and manufactures medical balloons for minimally invasive devices serving a global portfolio of medical device companies.
 
Boston Scientific receives FDA approval of completely subcutaneous implantable defibrillator
Cardiac devices and equipment : 03 October, 2012
The US Food and Drug Administration has granted 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).
 
Boston Scientific launches new PTCA balloon dilatation catheter in the USA
Catheters : 02 October, 2012
Boston Scientific receives US Food and Drug Administration clearance for the Emerge Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter and has begun marketing the device in the United States.
 
Cook Medical extends European distribution support
Minimally invasive medical devices : 02 October, 2012
Cook Medical is extending the company' European operations with the opening of a new Euros 15m distribution centre in Baesweiler, Germany.
 
Maxim Integrated develops telehealth reference design for vital signs monitoring shirt
Electronic components : 24 September, 2012
Maxim Integrated is collaborating with Clearbridge VitalSigns and Orbital Research to develop a reference design for a highly integrated, telehealth fitness (′Fit’) shirt to enable patient monitoring and lower the cost of medical diagnoses.
 
New con​figurable AC-DC powe​r supply achieves Thir​d Edition IEC 60601 ​Medical Safety Stand​ard
Power supplies and devices : 20 September, 2012
All versions of Emerson Network Power's configurable ac-dc power supplies that feature medical safety approvals are now compliant with the third edition of the ANSI/AAMI ES60601-1:2005 / IEC 60601-1 medical safety standard.
 
Aptus Endosystems receives FDA clearance for thoracic-length HeliFX aortic securement system
Cardiac devices and equipment : 19 September, 2012
Aptus Endosystems receives 510(k) clearance from the US Food and Drug Administration (FDA) for its thoracic-length HeliFX Aortic Securement System.
 
DT Research releases first fully battery powered all-in-one medical cart computer
Power supplies and devices : 18 September, 2012
DT Research unveils the DT590 All-in-One Medical Cart Computer, which is fully powered by swappable batteries for anywhere, anytime operations.
 
Covidien releases new device for endovascular treatment of peripheral vascular disease
Catheters : 18 September, 2012
Covidien is launching the Viance Crossing Catheter and Enteer Re-entry System for treating chronic total occlusions (CTOs) endovascularly.
 
University of Kentucky Medical Center transplants State's first SynCardia total artificial heart patient
Cardiac devices and equipment : 17 September, 2012
SynCardia Systems the manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, reveals that University of Kentucky (UK) Medical Center has successfully transplanted its first patient to receive the SynCardia temporary Total Artificial Heart.
 
QIAGEN partners Lepu Medical to provide rapid diagnosis of heart attacks
Cardiac devices and equipment : 17 September, 2012
QIAGEN signs an agreement with Lepu Medical Technology (Beijing), a leading medical device company in China, to provide QIAGEN's ESEQuant Lateral Flow System for use in emergency rooms with Lepu's tests for cardiac markers that diagnose acute myocardial infarction (heart attack).
 
World's smallest pacemakers feature algorithms to improve patient safety
Pacemakers : 14 September, 2012
Sorin Group receives marketing approval from China's State Food and Drug Administration (SFDA) and full commercial launch in China of the REPLY and ESPRIT families of pacemakers.
 
Abiomed receives FDA 510(k) clearance for percutaneous heart pump
Catheters : 11 September, 2012
Abiomed receives 510(k) clearance from the US Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella device providing peak flows of approximately four litres of blood per minute.
 
Cook Medical unveils otolaryngology/head and neck surgery division
Needles : 11 September, 2012
Cook Medical launches its new Otolaryngology/Head and Neck Surgery (OHNS) clinical division to bring the benefits of the company's devices for non-surgical procedures to a new group of physicians and the patients they treat.
 
Endoscopic ablation system data offers single procedure chronic success rates in AF treatments
Cardiac devices and equipment : 10 September, 2012
CardioFocus, the developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), is reporting new data showing pulmonary vein isolation (PVI) with its technology leads to a 99 percent acute success rate and up to an 82 percent chronic success rate at 12 months follow-up.
 
New software tool enables accurate projection of large-scale medical images
Displays and monitors : 07 September, 2012
Barco is releasing Conference CloneView for projecting high-quality medical images onto a large-screen display.
 
St Jude Medical realigns business units to support future growth
Cardiac devices and equipment : 03 September, 2012
St Jude Medical is realigning the company's product divisions into two new operating units: the Implantable Electronic Systems Division (IESD) and the Cardiovascular and Ablation Technologies Division (CATD).
 
Renal denervation technology demonstrates safe, rapid reduction in blood pressure
Cardiac devices and equipment : 30 August, 2012
St Jude Medical reveals interim data which demonstrates the company's EnligHTN renal denervation system is safe and effective for the treatment of resistant hypertension.
 
OmniGuide completes USD35m financing with OrbiMed
Laser systems : 30 August, 2012
OmniGuide closes a $35 million non-dilutive financing with an affiliate of OrbiMed Advisors in a financing structure that allows OmniGuide significant flexibility for the next several years as the company grows its business and advances toward profitability.
 
Catheter Connections signs distribution deal with Merit Medical Systems
Catheters : 30 August, 2012
Catheter Connections is entering into an exclusive distribution agreement with Merit Medical Systems, a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology.
 
IABP-SHOCK II clinical trial reveals results for cardiogenic shock
Balloons : 29 August, 2012
MAQUET Cardiovascular reveals 30-day results from the large, randomized, multicentre IABP-SHOCK II clinical trial in patients with acute myocardial infarction (AMI) who were in cardiogenic shock and undergoing early revascularization.
 
Trial results reveal better patient outcomes with FFR-guided cardiac stenting
Cardiac devices and equipment : 29 August, 2012
St Jude Medical is reporting results of the FAME II Trial demonstrating that patients with FFR-guided stenting plus the best available medical therapy had superior outcomes to those treated with medical therapy alone.
 
Left atrial appendage closure device receives CE Mark approval for expanded use
Cardiac devices and equipment : 28 August, 2012
European regulators have approved an expanded indication for the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure Device.
 
Smiths Medical agrees distribution deal with Nexus Medical
Catheters : 22 August, 2012
Smiths Medical signs an agreement with Nexus Medical to distribute the company's family of Nexus TKO anti-reflux needle free valves and extension sets in the USA and Canada.
 
IMS becomes sole distributor for RxEnergy NeverDie lithium ion batteries
Power supplies and devices : 21 August, 2012
IMS is named as the sole distributor for RxEnergy's NeverDie lithium ion batteries.
 
ZOLL enters technoloy partnership with Inovise Medical
Cardiac devices and equipment : 21 August, 2012
ZOLL Medical is entering into an agreement to license Inovise Medical's ambulatory AUDICOR technology as part of the advanced patient diagnostics in the LifeVest Wearable Defibrillator.
 
New sensor reveals next generation of intraoral digital radiography
Sensors : 15 August, 2012
Sirona Dental Systems is launching Schick 33, a new intraoral digital sensor and image management system which claims to be the most advanced sensor in dentistry, delivering an unparalleled combination of high-resolution images, dynamic image management, and it integrates with existing Schick systems.
 
Value Plastics unveils new tubing connector design
Connectors : 10 August, 2012
Value Plastics, a Nordson Company, is introducing the BPL Series of tubing connectors, a new alternative to Luer fittings.
 
Berlin Heart gains approval for paediatric VAD post approval study protocol
Cardiac devices and equipment : 08 August, 2012
The FDA grants approval for Berlin Heart's Post Approval Study, a condition of the 'Humanitarian Device Exemption' (HDE) approval that Berlin Heart received for the EXCOR Pediatric Ventricular Assist Device (VAD) on December 16, 2011.
 
CardioNet plans to acquire CardioCORE Lab
Cardiac devices and equipment : 08 August, 2012
CardioNet is entering into a definitive merger agreement with cardioCORE Lab, a leading centralied cardiac testing laboratory with locations near Washington, DC, San Francisco, California and London, UK.
 
Analog Devices unveils lowest power single-lead heart-rate monitor AFE
Electronic components : 07 August, 2012
Analog Devices is introducing a low-power, single-lead, heart-rate monitor analogue front end (AFE) for a wide range of vital sign monitoring applications.
 
Actuated Medical gains FDA clearance for TubeClear patient feeding tubes
Tubes and tubing : 03 August, 2012
The US Food and Drug Administration (FDA) determines substantial equivalence of Actuated Medical's TubeClear system specific to nasogastric (NG) feeding and decompression tubes.
 
Proteus Digital Health receives FDA clearance of ingestible sensor
Sensors : 01 August, 2012
The US Food and Drug Administration (FDA) clears Proteus Digital Health's ingestible sensor for marketing as a medical device.
 
Family of pacemakers receives CE Mark approval for use in MRI scans
Pacemakers : 30 July, 2012
Boston Scientific receives CE Mark approval for use of its INGENIO and ADVANTIO pacemakers in patients in need of a magnetic resonance imaging (MRI) scan.
 
Maquet equips new Japanese hybrid OR demo and training facility with Barco surgical displays
Displays and monitors : 26 July, 2012
Maquet, a global market leader in surgical medical equipment, is equipping the company's brand-new showroom in Kobe, Japan, with Barco MDSC-2124 HD surgical displays.
 
Industry's first octal ultrasound receiver reduces processor overhead in ultrasound systems
Electronic components : 24 July, 2012
Analog Devices introduces the industry's first octal (eight-channel) ultrasound receiver with on-chip digital I/Q demodulation and decimation filtering.
 
Covidien's Solitaire FR revascularization device receives regulatory approval in Brazil
Cardiac devices and equipment : 23 July, 2012
Covidien's Solitaire FR Revascularization Device has been approved by Brazil's National Health Surveillance Agency.
 
Salford Royal NHS Foundation Trust infusion pumps to pain management test
Pumps and dispensers : 18 July, 2012
For the past eight years the Salford Royal NHS Foundation Trust put to the test CME Medical's infusion pumps to the test.
 
St Jude Medical launches first small quadripolar CRT-D device in Japan
Cardiac devices and equipment : 18 July, 2012
St Jude Medical is launching the Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) in Japan.
 
New bipolar resection software application helps minimise hospital costs
Sensors : 16 July, 2012
Covidien unveils the North American introduction of a new bipolar resection in saline software application for its ForceTriad energy platform.
 
MAQUET rolls out new international marketing and service organizations
Cardiac devices and equipment : 13 July, 2012
MAQUET is continuing its international expansion strategy by setting up new subsidiaries in Colombia, South Africa and South East Europe and the take-over of the Cardiac Assist business division from USCI in Japan.
 
Angioslide completes first successful below-the-knee procedures in the USA
Balloons : 13 July, 2012
Angioslide deploys a 3X100mm PROTEUS device for treating Peripheral Artery Disease in below-the-knee (BTK) vasculature at Community Hospital in Munster, Indiana, USA.
 
New study shows accuracy of instrument to screen for CO poisoning
Pulse oximeters : 11 July, 2012
Masimo announces a new study in Respiratory Physiology and Neurobiology shows that noninvasive carboxyhaemoglobin (SpCO) and methaemoglobin (SpMet) measurements with Masimo rainbow Pulse CO-Oximetry are accurate and conclude they can be used as an effective first screening test with emergency room patients suspected of suffering carbon monoxide (CO) poisoning (Ref 1).
 
Nice University Hospital installs non-invasive cardiac support pump
Cardiac devices and equipment : 11 July, 2012
Nice University Hospital in Nice, France is equipping the hospital and the local fire brigade with the ZOLL Medical's AutoPulse Non-invasive Cardiac Support Pump.
 
Sorin Group invests in Cardiosolutions to develop mitral valve technology
Catheters : 10 July, 2012
Sorin Group is making a minority investment in Cardiosolutions, an early-stage company focused on the development of an innovative percutaneous system to treat patients with moderate to severe mitral valve regurgitation.
 
US military opts for Masimo Rad-57's handheld pulse CO-Oximeter
Pulse oximeters : 05 July, 2012
The US Department of Defense Military Health System selects the Masimo Rad-57 Handheld Pulse CO-Oximeter as the military's standardized handheld pulse oximeter for use worldwide.
 
Boston Scientific completes enrollment in study for first-in-class LAA closure device
Cardiac devices and equipment : 04 July, 2012
Boston Scientific completes enrollment in the PREVAIL confirmatory study, designed to gain US Food and Drug Administration (FDA) approval for the WATCHMAN Left Atrial Appendage (LAA) Closure device.
 
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