Kalila Medical, a privately held medical device company focused on the development of next-generation steerable catheter technologies, today announced it has received CE mark approval for its Vado™ Steerable Introducer Sheath for ...
Tags: Kalila Medical, CE mark approval, Vado™Steerable Introducer Sheath
Baxter International Inc. (NYSE:BAX) today announced completion of CE marking in Europe for the VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High ...
Oticon Medical, a manufacturer of bone anchored hearing systems, has obtained 510(k) approval the US Food and Drug Administration (FDA) to market its Ponto Plus bone anchored sound processors in regular version (down to a hearing loss of ...
Tags: Oticon Medical, Ponto Plus Bone
US-based medical technology company Medtronic has announced the randomization of the first patients in the SYMPLICITY HTN-4 clinical trial at Medical University of South Carolina, Piedmont Heart Institute and Duke University Medical Center. ...
Boston Scientific has obtained CE Mark approval for its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4 quadripolar LV ...
Tags: CRT-D Systems, CE Mark
St. Jude Medical, a medical device company, has obtained CE Mark approval in Europe for its 25mm Portico transcatheter aortic heart valve implantation system. The Portico valve system offers a minimally invasive treatment option for ...
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 ...