Archive for April 2018

  On April 17, FDA Commissioner Scott Gottlieb released a statement regarding the agency’s latest efforts to enhance and modernize its approach to medical device safety and innovation. Aimed at protecting patients and promoting public health, the Medical Device Safety Action Plan outlines how the agency will encourage innovation to improve safety, detect safety risks…

  Today, Abbott announced the latest in what it has described as a planned series of cybersecurity updates for the company’s implantable cardioverter defibrillators (ICDs). The voluntary recall reportedly applies to 382,000 devices in the U.S. alone, 350,000 of which are currently implanted in patients. The FDA said in its simultaneous alert about the firmware…