Originally Published MX July/August 2005
BUSINESS NEWS
Different PathsGE Healthcare has named Joe Hogan to succeed Sir William Castell as president and CEO when Castell retires in 2006. The appointment was made in conjunction with the announcement of a corporate reorganization for parent General Electric Co. (Fairfield, CT). The company's healthcare business will continue to be based in Chalfont St. Giles, UK.
FDA has issued a warning letter to Medtronic Inc. (Minneapolis) because of problems associated with cable connectors on the company's LifePak 12 cardiac defibrillators. The letter raised concern about Medtronic's manufacturing and quality assurance systems, and criticized the company for improper complaint handling, including failure to properly investigate a patient death.
Responding to FDA's request for input on the agency's critical path initiative, industry association AdvaMed (Washington, DC) has formed a new critical path coordination group to oversee the creation of a medical devices development model. The model will outline the process by which medical technologies progress from initialconception through their life on the market. The association believes such a model will enable device manufacturers to demonstrate to policymakers how their development models differ from those used in other healthcare sectors.
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