• 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...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

    The medical device industry is being shaken by a series of issues involving St. Jude Medical's defibrillator leads, reports The New York Times , leading to serious questions about transparency, adequate regulation and patient safety. The medical device leads have been implicated in a series of serious adverse events, including some where the wire contained inside the defibrillator leads have failed, leaving the wires to become exposed. The Times reports two other med...
  • Study: Medical Device Safety Could Be Improved With Help of Software

    • 09 March 2012
    A new study published in the American Health Association's journal Circulation: Cardiovascular Quality and Outcomes says that commercially available software could discover problems with medical devices well before traditional adverse event tracking systems are able to, reports Fierce Health IT . The study looked at 2710 implantable cardioverter-defribrillator leads, of which 107 failed during the study. Software used by the study was able to successfully alert the au...