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
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
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 ...
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
US-based Boston Scientific has obtained an approval from the US Food and Drug Administration (FDA) for its Promus PREMIER everolimus-eluting platinum chromium coronary stent system. The company's next-generation durable polymer ...
Global medical company Sorin has obtained CE Mark approval for the XL version of Perceval, a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive ...
Tags: Sorin, CE Mark, Aortic Valve
BonAlive Biomaterials, a manufacturer of implantable medical devices for bone regeneration, has announced the CE Mark approval and the launch of a patented, ready-to-use and mouldable version of its osteostimulative BonAlive bioactive glass ...
Global medical company Sorin has announced the CE Mark approval and first implantation of the new Solo Smart biological aortic pericardial heart valve in Europe. Solo Smart is the evolution of the company's Freedom Solo pericardial aortic ...
Tags: Heart Valve, Health, Medicine
The Direxion Torqueable Microcatheter-a microcatheter for shrinking tumors or blocking aneurysms-has won FDA and CE Mark approval, Boston Scientific recently announced. The FDA granted the Direxion a 510(k) clearance because it retains ...
Tags: Boston Scientific Microcatheter, FDA Approval, Direxion a 510(k)
A biomedical engineer is developing a clinical-grade open-source 12-lead ECG. The device includes support for Android devices and is designed to meet all relevant medical device manufacturing standards, like ISO 60601-1. According to early ...