Archive for ◊ May, 2013 ◊

• Friday, May 31st, 2013

GE Healthcare Announces 510(k) Clearance of New Brivo Plus C-arm for the US New OEC Brivo Plus C-arm is the first from GE’s Brivo line to be available in the US SALT LAKE CITY–(BUSINESS WIRE)–GE Healthcare announced today FDA 510(k) clearance of its latest Brivo Plus C-arm, now available in the US. With legacy OEC […]

• Friday, May 31st, 2013

New institute aims to attract 100 research scientists to Indiana Indianapolis, Ind., May 30, 2013 –Indiana Governor Mike Pence joined Indiana-based global life sciences and research university executives today to unveil the Indiana Biosciences Research Institute, the first industry-led collaborative life sciences research institute in the country. The Indiana Biosciences Research Institute is a statewide […]

• Friday, May 31st, 2013

A new, streamlined approach to genetic engineering drastically reduces the time and effort needed to insert new genes into bacteria, the workhorses of biotechnology, scientists are reporting. Published in the journal ACS Synthetic Biology, the method paves the way for more rapid development of designer microbes for drug development, environmental cleanup and other activities. Keith […]

• Friday, May 31st, 2013

Edwards Lifesciences Comments on FDA Warning Letter IRVINE, CA–Edwards Lifesciences Corporation (NYSE: EW) announced today that it has received a warning letter from the Denver District Office of the U.S. Food and Drug Administration (FDA) resulting from an inspection of Edwards’ facility in Draper, Utah, that concluded in Feb. 2013. The FDA warning relates specifically […]

• Friday, May 31st, 2013

Resistance to treatment with Tamiflu (oseltamivir) and similar drugs in people who have the H7N9 flu virus has now been confirmed, according to new research published in The Lancet. Described as one of the most detailed virological studies of the H7N9 virus to date, the study was led by Dr Zhenghong Yuang of the Shanghai Public […]

• Friday, May 31st, 2013

Advances in 3D and 4D ultrasound technology now offer capabilities ranging from better visualization of congenital birth defects to dynamic, multiplanar views of the fetal heart. Along with advances on the research front, the growing availability of 3D and 4D ultrasound technology has also increased public access to these ultrasound services—increasing the potential for safety […]

• Thursday, May 30th, 2013

While Intuitive Surgical (Sunnyvale, CA) faces dozens of patient injury lawsuits related to its da Vinci robotic surgery system, its first patient injury lawsuit has ended in victory for the company, according to Bloomberg. In the 10–2 verdict, a Washington jury decided that the company did not demonstrate negligence in its robotic surgery training program. […]

• Thursday, May 30th, 2013

Heli-FX™ Guide Designed to Treat Wide Neck Abdominal Aortic Aneurysms Receives FDA Clearance SUNNYVALE, Calif.–(BUSINESS WIRE)– Aptus Endosystems, Inc. announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 28mm Tip Reach Heli-FX Guide. A line extension of the original Heli-FX System, the new product enhances treatment of […]

• Thursday, May 30th, 2013

Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent Recall Class: Class I Date Recall Initiated: April 18, 2013 Product: Zilver PTX Drug-Eluting Peripheral Stent, catalog number ZIV6-35-125-6-80-PTX This recall includes all sizes, diameters and lot numbers prior to April 16, 2013. Bare metal versions of Cook’s Medical Zilver Flex use a different delivery system and […]

• Thursday, May 30th, 2013

Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for use of the GUIDE DBS System, the world’s first deep brain stimulation (DBS) visualization system. GUIDE DBS provides clinicians with 3D visualization information that simulates stimulation output, which may reduce programming time and enable more precise targeting of therapy. With GUIDE DBS, physicians are […]