The year ends with China on the precipice of big challenges. Growth is widely expected to slow again in 2014, as the country's economy matures and old standbys like exports and infrastructure spending lose some of their punch. Beijing has ...
Tags: Agriculture, Food
After seeing its revenue fall over the past years, Boston Scientific is looking to boost its bottom line in China. The company is adding employees in China and is debuting surgeon-training centers there, according to a Wall Street Journal ...
Despite significant headwinds, several medtech companies flourished in the past year while several stumbled. Here are five of the most successful: DexCom, a glucose monitoring specialist, has seen the value of its stock nearly triple in ...
Tags: medical device, medtech companies
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
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
Boston Scientific has reported favorable results assessing real-world experience with the Precision Spectra spinal cord stimulator system. New retrospective data highlighting the Boston Scientific Precision Spectra spinal cord stimulator ...
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 ...
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)
Let's say a large medical device company has developed a new computer heart simulator that the FDA thinks is acceptable for running tests--or a new clinical trial design in a cutting-edge field. In the past, a small, early-stage company ...
Tags: Big Medtechs, public-private Medical Device Innovation Consortium, FDA
US-based Boston Scientific has obtained CE Mark approval for its Vercise deep brain stimulation (DBS) system for the treatment of intractable primary and secondary dystonia. Dystonia is a neurological movement disorder characterized by ...
Tags: Dystonia Treatment, DBS System
Boston Scientific, a medical device company, has obtained the US Food and Drug Administration clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to facilitate selective access and delivery of diagnostic, ...
Tags: Boston Scientific, Microcatheter
Posted in Cardiovascular by Qmed Staff on November 19, 2013 The Sapien 3 could be used in a broader range of patients than earlier TAVR products introduced internationally. Edwards Lifesciences (Irvine, CA) is in the news after The ...
Boston Scientific has reported the first two commercial implants of Lotus valve system in a German hospital. Dr Gerhard Schuler and Dr Axel Linke led the procedures at the Heart Center - University Hospital Leipzig, Germany. CE Mark ...
Tags: Boston Scientific, Lotus Valve
In August, Medtronic was forced to remove its CoreValve percutaneuous heart valves from the market in Germany in light of a ruling that found that the device infringed on patents held by Edwards Lifesciences. A German appeals court, ...
Medtronic has obtained the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software for use with non-Medtronic leads to detect defibrillator lead issues. LIA software has been approved by the FDA to ...
Tags: Medtronic, PDA, LIA, non-medtronic