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Medical Device Technology
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.
 
TLT claims breakthrough in foetal heart monitoring
Sensors : 27 February, 2012
Tarilian Laser Technologies is releasing a ground-breaking early research prototype for a foetal heart monitoring sensor.
 
Barco introduces the industry's first custom medical display cart
Displays and monitors : 24 February, 2012
Barco develops a new 19-inch sealed medical display purpose-built for Rubbermaid Medical Solutions' medical carts.
 
New study to evaluate FFR's economic impact in Asia and Australia
Cardiac devices and equipment : 20 February, 2012
St Jude Medical is to evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in Japan, China, India, Korea, and Australia.
 
Multi-touch input system features glass surface
Keyboards and input devices : 20 February, 2012
Schurter's new PCI (Projected Capacitive Input) touch-screen technology expands the company's family of input systems with glass surfaces that cover the entire operating area on the front.
 
Stereotaxis gains Health Canada clearance for Vdrive system
Catheters : 10 February, 2012
Stereotaxis' Vdrive Robotic Navigation System, which provides physicians the ability to remotely manipulate traditionally non-robotic catheters, is expected to surpass 500 clinical procedures in Europe in February 2012.
 
Crossing device treats complete blockages in peripheral arteries
Cardiac devices and equipment : 09 February, 2012
Boston Scientific is launching the TruePath CTO Device, designed to facilitate the crossing of chronic total occlusions (CTOs, or complete blockages) within the peripheral vasculature, to the US market.
 
Boston Scientific launches endoscopic ultrasound aspiration needle
Needles : 08 February, 2012
Boston Scientific is launching the Expect 19 Flex Endoscopic Ultrasound Aspiration Needle, used for acquiring tissue samples under Endoscopic Ultrasound (EUS) guidance for cancer diagnosis in organs adjacent to the gastrointestinal tract.
 
ETView files 510(k) application for new endobronchial blockers
Catheters : 08 February, 2012
ETView completes the filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for the Viva EB line of innovative endobronchial blockers.
 
Schurter unveils plug-retention safeguard for power cords
Power supplies and devices : 07 February, 2012
Schurter is introducing the V-Lock system which conforms to the 'American Hospital Grade' and prevents unintentional unplugging of power cords on equipment.
 
Barco acquires patient bedside terminal provider JAOtech
Displays and monitors : 06 February, 2012
Barco signs an agreement to acquire UK-based JAOtech, a leading manufacturer of patient entertainment and point-of-care terminals for hospitals.
 
Sorin launches new portfolio of pacing and defibrillation leads
Cardiac devices and equipment : 02 February, 2012
Sorin Group receives CE Mark approval and commercial launch for a comprehensive new range of pacing, defibrillation and left ventricular leads. Designed for safety and long term reliability, TILDA pacing leads, VIGILA defibrillation leads and CELERITY left ventricular lead families offer multiple implant options to accommodate patients' needs and physicians' preferences.
 
FDA approves Medtronic's DF4 high-voltage connector for ICDs
Connectors : 02 February, 2012
Medtronic is launching the DF4 High-Voltage Connector System following receipt of US Food and Drug Administration (FDA) approval.
 
Cardinal Health partners Cook for vascular access kitting sets
Catheters : 01 February, 2012
Cardinal Health and Cook Medical are signing a two-year, exclusive agreement for the North American distribution of Cook Medical central venous catheter (CVC) sets with Cardinal Health Presource customizable procedural kits - providing clinicians with advanced technology the flexibility of customization for their vascular access needs.
 
Barco launches Healthcare Helpdesk service in Europe
Displays and monitors : 31 January, 2012
Barco is launching the company's new European Image.Care Healthcare Helpdesk service which is a new initiative that takes the company's customer service to the next level.
 
Molex forms global medical business unit
Connectors : 31 January, 2012
Molex is initiating several strategic business developments to further demonstrate its commitment to developing innovative interconnect technologies for next-generation healthcare devices.
 
Biotronik completes testing of IDC home monitoring system
Cardiac devices and equipment : 27 January, 2012
Biotronik completes the company's final interoperability testing process for Biotronik Home Monitoring, an Internet-based system for patient and implantable cardiac device information.
 
Congenital heart patients benefit from wireless cardiac implant
Cardiac devices and equipment : 27 January, 2012
A miniature, battery-free, wireless, cardiac implant being developed by a U-M researcher and the Ann Arbor company Integrated Sensing Systems, ISSYS), is receiving important funding that could get it to patients more quickly.
 
CoreValve US trial completes enrollment of extreme risk patients
Cardiac devices and equipment : 26 January, 2012
Medtronic completes patient enrollment in the extreme risk study in its CoreValve US Pivotal Trial and the company has also received approval from the US Food and Drug Administration (FDA) for an extended investigation (under the FDA's Continued Access Policy) to continue enrolling extreme risk patients under a Continued Access Study protocol.
 
IVC filter receives CE mark approval
IVC filters : 25 January, 2012
Crux Biomedical receiveds CE mark approval for the company's inferior vena cava filter (IVCF) with bi-directional retrieval (BDR).
 
St Jude Medical's FAME II trial receives positive interim analysis
Cardiac devices and equipment : 19 January, 2012
St Jude Medical is reporting that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease.
 
Biotronik opens new Asia Pacific HQ in Singapore
Pacemakers : 16 January, 2012
Biotronik, a manufacturer of high quality products for vascular intervention, implantable cardiac pacemakers and defibrillators, and the pioneer of wireless remote monitoring technology, is opening of a new regional headquarters location based in Singapore.
 
New metal pushbutton switches feature ceramic actuator faces
Electronic components : 09 January, 2012
A new model with a patented ceramic actuator face expands Schurter's MSM family of metal pushbutton switches with rugged background illumination over the full actuator surface.
 
St Jude Medical reveals cardiovascular division growth plans
Cardiac devices and equipment : 06 January, 2012
St Jude Medical plans to expand its presence in Plymouth, Minnesota, USA, with a construction project designed to expand its current facilities and consolidate operations for the company's cardiovascular division.
 
Dongbu HiTek achieves ISO13485 quality management certification
Electronic components : 06 January, 2012
Dongbu HiTek is now certified to meet all international quality management criteria set forth in the ISO13485 standard for the medical device industry.
 
St Jude Medical closes patient enrollment in RESPECT clinical trial
Cardiac devices and equipment : 04 January, 2012
St Jude Medical meets a stopping rule in its RESPECT clinical trial - triggered by reaching the protocol-required number of primary events in the trial, defined as stroke and all-cause mortality - and is closing patient enrollment.
 
Delcath's Irish operations achieves ISO 13485 certification
Drug delivery equipment : 29 December, 2011
Delcath Systems'Galway, Ireland location achieves ISO 13485:2003 Certification, which is an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU).
 
Covidien receives CE Mark for Nellcor Respiration Rate Software
Sensors : 23 December, 2011
Covidien is to label the Covidien Nellcor Respiration Rate Version 1.0 Software and the Adult Respiration Rate Sensor with the CE Mark, making the new respiratory monitoring platform available throughout the European Economic Area (EEA).
 
Smiths Medical extends multi-therapy smart infusion system availability
Pumps and dispensers : 22 December, 2011
Smiths Medical is launching the CADD-Solis VIP ambulatory infusion system with CADD-Solis medication safety software in France, Germany, Switzerland and the Netherlands.
 
TLT sensor helps detect White coat hypertension
Sensors : 21 December, 2011
Tarilian Laser Technologies (TLT) confirms, from early studies, the ability of its Sapphire sensor technology to detect white coat hypertension (WCH) during measurement of blood pressure in a clinical setting.
 
Revolutionary optical blood pressure sensor to be made in the UK
Sensors : 19 December, 2011
Tarilian Laser Technologies (TLT), developer of an optoelectronic sensor for measuring blood pressure, is planning to build manufacturing capabilities for sensor-based devices in-house at the company's Welwyn Garden City headquarters.
 
Aptus Endosystems completes first HeliFX procedures in USA
Cardiac devices and equipment : 14 December, 2011
Aptus Endosystems, a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), is reporting the successful treatment of the first series of patients in the USA with the HeliFX Aortic Securement System after having received FDA clearance.
 
Boston Scientific launches new PTA balloon catheter in the USA
Catheters : 13 December, 2011
Boston Scientific is launching in the USA the company's Charger PTA Balloon Catheter, a 0.035 inch percutaneous transluminal angioplasty (PTA) balloon catheter designed for a wide range of peripheral angioplasty procedures.
 
ALOKA helps European Prevention Centre to diagnose CHD earlier
Cardiac devices and equipment : 13 December, 2011
ALOKA is collaborating with Prof Uwe Nixdorff of the European Prevention Centre, Dusseldorf to advocate cardiologists worldwide begin using new functionalities for earlier diagnosis of coronary heart disease - enabling a preventative rather than reactionary approach to this pandemic disease.
 
National Innovation Centre spotlights ALFApump's cost saving benefits
Pumps and dispensers : 13 December, 2011
Sequana Medical is reporting the findings of an independent economic assessment of the ALFApump System commissioned by the National Innovation Centre, the NHS organization which supports innovators, commissioners, and clinicians to speed up the development and use of innovations that will benefit the NHS.
 
Abiomed focuses on expanding its heart recovery strategy
Cardiac devices and equipment : 12 December, 2011
Abiomed is expanding the company's heart recovery strategy along with new initiatives that are expected to enhance strong, multi-year double digit sales and earnings growth.
 
Molex strengthens micro product support for medical technology
Connectors : 08 December, 2011
Molex is offering a selected series of core micro products, which will be available for purchase, replacement and technical support for up to ten years, in order to more accurately align with medical industry design cycles.
 
Embolic protection device receives US FDA clearance
Cardiac devices and equipment : 06 December, 2011
The US Food and Drug Administration (FDA) clears Covidien's SpiderFX for the treatment of severely calcified lesions used in conjunction with plaque excision in arteries of the lower extremities.
 
University of Toledo equips new immersive simulation centre
Displays and monitors : 05 December, 2011
Barco's I-Space and CADWall systems is being installed by the University of Toledo, serving as the cornerstone of a new virtual immersive reality center designed to educate future generations of physicians, nurses and allied health professionals.
 
Boston Scientific offers leading ICD and CRT-D device warranties
Cardiac devices and equipment : 02 December, 2011
Boston Scientific's introduction of a new family of INCEPTA and ENERGEN implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) will be supported with an extended warranty for these devices in the USA and many international countries of up to 10 years, depending on model.
 
DSM develops novel scar reduction product for spine surgeries
Drug delivery equipment : 02 December, 2011
DSM signs a joint collaboration agreement with AdeTherapeutics to accelerate the company's scar reduction and pain management product development strategy in neurosurgery, specifically in spine surgery and craniotomy.
 
Report spotlights benefits of continuous home monitoring
Cardiac devices and equipment : 02 December, 2011
Biotronik is reporting the publication of 'Detection of atrial high-rate events by continuous Home Monitoring: clinical significance in the heart failure-cardiac resynchronization therapy population' in Europace by Dr Nesan Shanmugam et al.
 
St Jude Medical receives FDA approval for first quadripolar pacer
Cardiac devices and equipment : 01 December, 2011
St Jude Medical receives US Food and Drug Administration (FDA) approval for the company's Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet Left Ventricular Quadripolar Pacing Lead.
 
New family of cardiac devices offer longest warranty
Cardiac devices and equipment : 01 December, 2011
Boston Scientific receives FDA approval of its INCEPTA, ENERGEN and PUNCTUA cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) to treat heart failure and sudden cardiac death.
 
Barco installs 1,100 medical displays for Irish NIMIS PACS project
Displays and monitors : 30 November, 2011
Barco is partnering with McKesson to supply medical display systems for NIMIS, Ireland's national PACS programme.
 
Lumax 740 implantable cardiac defibrillators complete first implants
Cardiac devices and equipment : 25 November, 2011
Biotronik is reporting the first implantations of the company's new Lumax 740 implantable cardiac defibrillators - the world's first and only ICDs eligible for use with magnetic resonance imaging.
 
IsoRay receives final regulatory approval for brain cancer treatment
Catheters : 24 November, 2011
IsoRay receives final approval from the State of Washington Department of Health to manufacture its GliaSite radiation therapy system, a balloon catheter device used in the treatment of brain cancer.
 
Nonin Medical launches world's first OEM solution for regional oximetry
Pulse oximeters : 22 November, 2011
Nonin Medical is launching the world's first Regional Oximetry OEM Solution, the EQUANOX Model 7610 which is designed for medical monitoring manufacturers who desire a low-power, integration-ready solution for integrating cerebral and tissue oximetry technology into their patient monitoring systems.
 
Freescale unveils Home Health Hub telehealth solution
Electronic components : 17 November, 2011
Freescale Semiconductor is introducing a home health hub (HHH) reference platform to help medical equipment manufacturers quickly and easily create remote-access devices that can collect, connect and securely share health data for improved healthcare management.
 
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