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(ITI Global: Milford, Ohio) – Hitachi Medical Corp. has received from its parent organization, Hitachi Ltd., the 2006 Innovation Award recognizing the most innovative product and process developed for the year. Hitachi Medical received the award for the multimodality console product…
(Food and Drug Administration: Rockville, Maryland) The U.S. Food and Drug Administration has unveiled a new Web page that will keep the public informed about the status of post-approval patient studies for certain recently approved medical devices. “FDA is committed to improving its medical…
(Angiotech Pharmaceuticals Inc., Vancouver) -- Angiotech Pharmaceuticals Inc., global specialty pharmaceutical and medical device company, recently announced the appointment of Victor Diaz as senior vice president, global manufacturing and supply chain management.“With his significant…
(Pilgrim Software, Tampa, Florida) -- Pilgrim Software, a provider of enterprise compliance and quality management software solutions, has been named 2007 North American Enterprise Compliance & Quality Management (ECQM) Company of the Year within the life sciences industry by Frost…
(Sparta Systems Inc.; Holmdel, New Jersey) Sparta Systems Inc., the maker of TrackWise, and an enterprise quality and compliance process management software provider, has released the Beta version of the TrackWise eMDR Submission Manager software. The add-on software enables medical…
Five pharmaceutical manufacturing facilities scattered around the globe recently received Facility of the Year awards for significantly advancing the industry’s efforts to produce higher-quality medicines at lower costs. The winners are: Cook Pharmica—Facility of the Year for Facility…
(Underwriters Laboratories Inc.; Northbrook, Illinois) -- Underwriters Laboratories Inc., a world leader in product safety testing, and certification and management system registrations, recently unveiled a service for the medical device industry that streamlines the regulatory…
Hitachi Medical Corp. (HMC) recently received the 2006 Innovation Award in recognition of its development of new products and processes. Almost 60 North American imaging and 140 Japanese hospitals helped define the critical product capabilities that Hitachi Medical and International…
Three medical device manufacturers—two in Mexico and one in the United States— recently received Shingo Prizes. Baxter Healthcare Corp.’s North Cove Plant in Marion, North Carolina; Baxter’s Cuernavaca Plant in Morelos, Mexico; and Cordis Corp. of Juarez, Mexico, received the awards,…
Blue Mountain Quality Resources Inc. and eCalibration.com have collaborated on a spring training schedule. The courses are designed to provide unique and leading-edge training for professionals working in regulated life sciences industries. The courses include: • Facilities and Equipment…
Solectron Corp. recently created an alliance for medical device outsourcing companies. The Solectron Medical Alliance Program (S-MAP) includes ATEK Medical, Circle Medical, Proven Process Medical Devices Inc. and SRI Product Development, as well as Solectron. The alliance creates one of…
QUMAS recently made its QUMAS R&D software suite available to biotechnology and pharmaceutical companies. QUMAS provides regulatory affairs and quality management solutions, and the new research and development suite is the first of a series for the life sciences that will focus on…
Agile Software Corp., a provider of product lifecycle management solutions, recently reported that CooperVision, a fast-growing manufacturer of contact lenses, has installed Agile Product Quality Management as its global quality solution earlier than expected.“It was the easiest and…
The Food and Drug Administration recently proposed recommendations to Congress that would broaden and upgrade the agency’s drug safety plan, increase resources for television advertising review and improve drug development processes. The recommendations are part of the reauthorization…
A Food and Drug Administration senior scientist will be the next chairman for the agency’s Global Harmonization Task Force, which was established as an international effort to improve the quality of medical devices and regulatory systems. Dr. Larry Kessler is director of the office of…
Pharmatech Associates Inc. has established a Regulatory Compliance Group that’s designed to help the consultancy’s clients ensure long-term drug development compliance with Food and Drug Administration regulations. The RCG’s team members include former FDA employees who have extensive…
Solectron Corp. will host an upcoming seminar on the effect of the restriction of hazardous substances (RoHS) directive on American medical device makers. RoHS is a European requirement that prohibits the marketing of electronic and electrical equipment that contains hazardous substances—…
COLA, a clinical laboratory education and consultation accreditation organization, recently received renewed approval from the Centers for Medicare and Medicaid Services (CMS) to accredit laboratories to meet requirements set by the Clinical Laboratory Improvement Amendments. A…
Siemens Medical Solutions recently completed the EUR 4.2 billion ($5.5 billion) acquisition of Bayer Healthcare’s diagnostic division and merged it with Diagnostic Products Corp., creating Siemens Medical Solutions Diagnostics.The new wholly owned subsidiary of Siemens Medical Solutions…
The Pharmaceutical Research and Manufacturers of America (PhRMA) recently kicked off a multimedia campaign to raise public awareness of diabetes. Nearly 21 million Americans know they have diabetes, and as many as 6.2 million more have it and don’t know that they have it. The purpose of…
Pharmaceutical services company i3 has entered the next phase of its global expansion which includes organic and acquired growth in India, Latin America and Europe. Coupled with acquisitions in Canada and Asia Pacific that i3 made earlier this year, the additions will help i3’s…
Three out of four life sciences companies polled in a recent survey said that their current documentation practices are inefficient. The survey was conducted in November and focused on key areas of life sciences firms that are heavily involved with complex documentation practices,…
Abbott Laboratories has completed its acquisition of Kos Pharmaceuticals Inc., which specializes in treatments for cardiovascular, metabolic and respiratory diseases, and is now a wholly owned subsidiary of Abbott Labs. Abbott reports that the acquisition broadens its portfolio of products…
Heartbeat Software Inc. has named Six Sigma Black Belt Irena Petsche its new vice president for professional services. Heartbeat Software is a provider of software for the life sciences industry. Petsche has 20 years’ experience in the software industry and was most recently director of…
The current research and development of dozens of major cancer therapies will spur enormous sales potential in the market over the next 15 years, according to a study by Pharmacor and Decision Resources Inc. The report says that five new classes of cancer drugs will jointly account for…