• 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...
  • 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...