Vascular Solutions, a medical device company, has obtained Shonin approvals from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its GuideLiner guide extension catheter and the SuperCross FT microcatheter. Japan Lifeline, ...
Tags: Vascular Solutions, medical device, MHLW, extension catheter
The US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority that the benefits of the Boston Scientific's WATCHMAN left atrial appendage closure device ...
Tags: FDA, Boston Scientific, WATCHMAN, left atrial appendage closure device
US-based SynCardia Systems has announced the implantation of the 150th SynCardia temporary total artificial heart in 2013. The 150th SynCardia temporary total artificial heart has been implanted on 26 November 2013. In 2012, a total of ...
Tags: Heart Implant, Syncardia Systems
Sorin, a medical device company, has received CE Mark approval for its Intensia family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices. The Intensia family includes single-chamber ...
Tags: medical device, CRT-D Devices
Saint-Gobain Glass has launched SGG DECORGLASS, a range of clear patterned glass. Providing an alternative to what is currently available on the market, this exclusive range offers six new designs creatively named WATERDROP, ENTRELAZADO, ...
Tags: glass, decoration
Medtronic's latest iteration of its Activa neurostimulator is not just a therapy device, but a brain activity information recorder that could provide insights into such devastating neurological disorders as Parkinson's disease. The first ...
Tags: health, Medtronic, neurostimulator, neurological disorders, Parkinson
Jarvik Heart, a manufacturer of cardiac assist devices, has announced the Shonin approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the Jarvik 2000 heart, a small left ventricular assist device implanted inside ...
Medtronic, a medical technology company, has announced CE Mark approval in Europe and Therapeutic Goods Administration (TGA) listing in Australia for its Symplicity Spyral catheter and Symplicity G3 radio frequency (RF) generator. ...
Tags: Medtronic, medical technology
US-based Sense4Baby has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its smartphone-based maternal/fetal monitoring system. The company has also obtained CE Mark approval from the European Commission for its ...
PrimeraDx, a molecular diagnostics company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ICEPlex C. difficile assay kit and the ICEPlex system. The ICEPlex system is a multiplex real-time PCR system ...
American Medical Systems, a subsidiary of Endo Health Solutions, has obtained CE Mark approval for its RetroArc retropubic sling system, designed to treat female stress urinary incontinence (SUI). In collaboration with leading physicians, ...
Germany-based eZono has obtained CE Mark approval in Europe for its eZono 4000 tablet ultrasound system with eZGuide. Incorporating the company's proprietary eZGuide needle guidance technology, the eZono 4000 is specifically designed for ...
Tags: Tablet Ultrasound System, Medicine
AB SCIEX, a developer of mass spectrometry products, has announced the launch of its AB SCIEX IVD-MS analyzer CE marked for general in vitro diagnostic use in Europe. The release of this mass spectrometry-based analyzer is in response to ...
Echo Therapeutics, a medical device company, has reported positive results from its clinical trial of the Symphony CGM wireless continuous glucose monitoring system in surgical patients in hospital critical care units. Echo Therapeutics ...
US-based Bruker has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its MALDI Biotyper CA system to identify Gram negative bacterial colonies cultured from human specimens. Bruker's MALDI Biotyper CA system ...