Medical equipment industry
The Food and Drug Administration's (FDA) delayed response to a flawed heart defibrillator has been criticized for costing a college student's life, highlighting the agency's alleged complicity in the silence. A report by Barry Meier revealed that the FDA received a report from the
Medical equipment industry
Boston Scientific Corporation (BSX) has announced the U.S. Food and Drug Administration (FDA) approval for the Wingspan Stent System with Gateway PTA Balloon Catheter, a device designed to treat atherosclerotic lesions in brain arteries. The Wingspan Stent System is the only device available in the U.S. for treating
Medical equipment industry
Boston Scientific Corp. is being sued by a Florida doctor and inventor who alleges that the company's artery-repair device, the Enovus AAA stent-graft, infringes on his patents. The device, which uses a stent-graft combination to repair abdominal aortic aneurysms, is still being tested in the United States but
Medical equipment industry
Boston Scientific's TAXUS clinical trials have been recognized by the European Society of Cardiology (ESC) for providing definitive evidence for treatment decisions in cardiology. The ESC guidelines emphasize the need for large-scale, multi-center, randomized, controlled trials with adequately powered primary clinical endpoints. Boston Scientific's TAXUS IV,
Medical equipment industry
SmallCap Sentinel's report "Innovations in Biotechnology" has been made available free of charge on their website, addressing stents and stent-related companies, including MIV Therapeutics, Inc. (OTCBB: MIVT), Angiotech Pharmaceuticals Inc. (NasdaqNM: ANPI), Conor Medsystems Inc. (NasdaqNM: CONR), and Guidant Corp. (NYSE: GDT). The report focuses on
Medical equipment industry
Guido J. Neels, a seasoned professional with over 30 years of experience in the medical industry, has been appointed to Biopure Corporation's board of directors. Neels brings a wealth of knowledge and expertise, having held various leadership positions at companies such as Guidant Corporation and Eli Lilly and
Medical equipment industry
The European Union's approval of Johnson & Johnson's proposed purchase of Guidant Corp. with conditions has left the final regulatory hurdle as the U.S. antitrust approval. The deal, valued at $25 billion, was agreed upon in December and approved by Guidant shareholders in April. However,
Medical equipment industry
Johnson & Johnson, a pharmaceutical and consumer goods company, has cleared a major hurdle in its $25.4 billion acquisition of Guidant Corp. The European Union's executive commission has approved the deal, provided that operations in some niche markets for cardiovascular devices are sold to guarantee fair competition
Medical equipment industry
TriPath Imaging, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu protein. This clearance expands the utility of VIAS as an aid to the clinical assessment of breast cancer. The system,
Medical equipment industry
TriPath Imaging Inc., a leader in molecular diagnostics, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu. This latest clearance expands the utility of VIAS as
Medical equipment industry
St. Jude Medical, a leading manufacturer of medical devices, has received approval from the U.S. Food and Drug Administration (FDA) for its SJM Biocor(R) and Biocor(R) Supra family of stented tissue valves. This approval marks a significant milestone for the company, allowing it to expand its portfolio
Medical equipment industry
Scott + Scott, LLC, a law firm specializing in complex litigation, including securities fraud, was surprised to learn that a New York Times Freedom of Information Act Request to the Food and Drug Administration (FDA) for information on faulty Guidant defibrillators was denied. The information sought by the Times concerned the
