• After Regulatory Issues Raised, Medtronic Plans to Heighten Postmarketing Safety Monitoring

    After a string of "headline-grabbing" recalls involving medical devices in recent months, Minneapolis-based medical device manufacturer Medtronic is announcing its intent to increase its postmarketing safety surveillance of its implantable products, reports Reuters . "The US Food and Drug Administration (FDA) alone does not have the infrastructure," said Medtronic CEO Omar Ishrak in an interview with Reuters , "so companies have to play a leading role in this." "We ne...
  • Report: Postmarketing Regulatory Troubles at St. Jude Depress Share Value

    The regulatory issues faced by St. Jude as a result of unfavorable reports concerning the safety of its Riata defibrillator leads-as well as the company's cessation of sales for its Quicksite and QuickFlex defibrillator leads-are causing more than just publicity problems for the company, reports Reuters . The regulatory issues are "raising concerns on Wall Street that doctors will curb use of the company's products, weakening its position in the $6.5 billion global mark...